Osteoarthritis Clinical Trial
Official title:
Assessing the Impact of MOVALIS on Health Related Quality of Life
| NCT number | NCT00619177 |
| Other study ID # | 107.273 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | February 8, 2008 |
| Last updated | January 30, 2015 |
| Start date | March 2007 |
The objective of the observational study is to examine the effect of MOVALIS (Meloxicam) therapy on Health Related Quality of Life (HRQoL) in the diverse region of Central and Eastern Europe. The Medical Outcomes Study 12 Item Short Form Health Survey version 2 (SF-12v2) will be used as the instrument to measure any change in physical wellbeing (Physical Component Summary, PCS) and mental wellbeing (Mental Component Summary, MCS) of patients following MOVALIS (Meloxicam) therapy.
| Status | Completed |
| Enrollment | 3569 |
| Est. completion date | |
| Est. primary completion date | May 2008 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria (according to Summary of Product Characteristics (SPC) ): 1. Male or female patients aged 18 years or above 2 Females of child bearing age must be using adequate contraception (hormonal or barrier method of birth control) 3. Patients with symptoms of acute, painful osteoarthritis or rheumatoid arthritis 4. Patients requiring therapy with non-steroidal anti-inflammatory drugs (NSAIDs) 5. Patients requiring either parenteral and/or oral NSAIDs 6. Patients who have not taken another NSAID or Cyclo-oxygenase-2 (COX-2) inhibitor in the previous 7 days Pain intensity on the visual analogue scale (VAS) 25 mm and above Exclusion Criteria (according to contraindications of Summary of Product Characteristics (SPC) ): 1. Known hypersensitivity to meloxicam or any excipient of the product, known or suspected hypersensitivity to analgesics, antipyretics or NSAIDs 2. Patients who have developed signs of asthma, nasal polyps, angio-oedema or urticaria following the administration of aspirin or other NSAIDs 3. Active peptic ulcer, gastrointestinal perforation or bleeding within the last 6 months 4. Severe liver failure 5. Non-dialysed severe renal failure 6. Pregnancy or breastfeeding 7. Haemostasis disorders or concomitant treatment with anticoagulants 8. Severe congestive heart failure |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Croatia | Boehringer Ingelheim Investigational Site | Split | |
| Croatia | Boehringer Ingelheim Investigational Site | Zagreb | |
| Czech Republic | Boehringer Ingelheim Investigational Site | As | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Babice | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Benátky nad Jizerou | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Benesov | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Benesov nad Ploucnicí | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Benesov u Prahy | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Beroun | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Bílina | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Bílovec | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Bílovice nad Svitavou | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Blansko | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Blatnice pod svatým Antonínkem | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Bohusovice nad Ohrí | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Bolatice | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Boskovice | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Bratríkov | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Breclav | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Brno | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Broumov | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Bruntál | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Buchlovice | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Bysice | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Bystrice nad Pernstejnem | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Cáslav | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Cernosice | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Cernozice | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Ceská Lípa | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Ceská Trebová | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Ceské Budojovice | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Ceský Tesín | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Cheb | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Chodov | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Chomutov | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Chropyne | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Chrudim | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Decín | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Dobrany | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Dobrís | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Dobruska | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Dol . Lou. | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Dolní Benesov | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Dolní Berkovice | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Domazlice | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Drnovice | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Dvur Králové nad Labem | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Frenstát | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Frýdek-Místek | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Frýdlant | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Fulnek | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Hanusovice | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Havírov | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Havlíckuv Brod | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Hermanuv Mestec | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Hlucín | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Hluk | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Hodonice | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Hodonín | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Holesov | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Holice | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Horice v Podkrkonosí | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Horní Berkovice | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Horní Slavkov | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Horovice | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Hostinné | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Hostka | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Hradec Králové | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Hrádek n.N. | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Hronov | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Hrusovany nad Jevisovkou | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Hulín | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Hustopece | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Hustopece u Brna | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Jablonec | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Jablonec n.N. | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Jablunkov | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Jaromer | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Javorník | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Jeseník | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Jicín | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Jihlava | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Jirkov | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Kadan | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Kaplice | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Karlovy Vary | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Karviná | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Kladno | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Klásterec n. Ohrí | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Klatovy | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Klobouky | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Kolín | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Konice | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Koprivnice | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Kosmonosy | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Kostelec nad Orlicí | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Kralupy nad Vltavou | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Králuv Dvur | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Krnov | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Kromeríz | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Krouna | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Krupka | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Kunovice | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Kurim | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Kyjov | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Lanskroun | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Ledec nad Sázavou | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Lenesice | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Letohrad | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Liberec | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Libesice | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Libochovice | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Lipová Lázne | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Litomerice | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Litovel | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Litvínov | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Lomnice n.P. | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Louny | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Lovosice | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Ludgérovice | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Mariánské Lázne | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Melník | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Mesto Albrechtice | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Milín | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Milovice | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Míretice | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Mladá Boleslav | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Mlázovice | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Mnísek pod Brdy | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Modrice | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Mohelnice | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Mor.Budejovice | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Mor.Krumlov | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Mor.Nová Ves | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Moravany | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Most | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Mýto | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Náchod | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Námest nad Oslavou | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Nasavrky | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Nechanice | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Neratovice | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Nová Ves pod Plesí | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Nové Mesto nad Metují | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Nový Bor | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Nový Bydzov | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Nový Jicín | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Nový Knín | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Nymburk | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Obratan | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Obríství | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Olomouc | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Opava | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Opocno | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Orlová | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Ostrava | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Otrokovice | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Pacov | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Pardubice | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Pelhrimov | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Petrvald | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Pierov | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Písek | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Planá | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Plzen | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Polná | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Postoloprty | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Postrelmov | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Prachatice | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Praha | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Prelouc | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Prestice | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Príbram | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Prostejov | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Radonice | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Rakovník | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Raspenava | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Revnice | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Rícany u Brna | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Rokycany | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Roudnice nad Labem | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Roznov pod Radhostem | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Ruda nad Moravou | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Rudná u Prahy | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Rumburk | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Rychnov nad Kneznou | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Rýmarov | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Saratice | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Semily | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Senov u NJ | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Skutec | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Slaný | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Slatinany | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Slavicín | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Slusovice | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Smidary | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Smirice | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Sokolov | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Spálené Porící | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Stáhlavy | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Staré Mesto | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Starý Plzenec | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Stenovice | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Stetí | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Strakonice | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Stríbro | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Studená | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Studénka | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Sumperk | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Svetlá nad Sázavou | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Tábor | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Teplice | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Tisnov | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Tlucná | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Touzim | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Trebíc | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Tremosná | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Trest | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Trinec | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Trutnov | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Tupesy | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Turnov | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Uherské Hradiste | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Uherský Brod | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Ústek | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Ústí nad Labem | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Ústí nad Orlicí | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Val.Bystrice | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Valasské Mezirící | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Vamberk | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Vápenná | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Varnsdorf | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Velká Bítes | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Velké Mezirící | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Velké Opatovice | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Velké Porící | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Veselí nad Moravou | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Vintírov | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Vlasim | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Vodnany | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Votice | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Vrbno pod Pradedem | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Vsetín | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Vyskov | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Vysoké Mýto | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Zábieh | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Zamberk | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Zastávka u Brna | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Zatec | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Zbýsov | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Zdár nad Sázavou | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Zinkovy | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Zirovnice | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Zlín | |
| Czech Republic | Boehringer Ingelheim Investigational Site | Znojmo | |
| Estonia | Boehringer Ingelheim Investigational Site | Elva | |
| Estonia | Boehringer Ingelheim Investigational Site | Haapsalu | |
| Estonia | Boehringer Ingelheim Investigational Site | Johvi | |
| Estonia | Boehringer Ingelheim Investigational Site | Kohtla-Jarve | |
| Estonia | Boehringer Ingelheim Investigational Site | Kose | |
| Estonia | Boehringer Ingelheim Investigational Site | Laane-Virumaa | |
| Estonia | Boehringer Ingelheim Investigational Site | Narva | |
| Estonia | Boehringer Ingelheim Investigational Site | Paide | |
| Estonia | Boehringer Ingelheim Investigational Site | Parne | |
| Estonia | Boehringer Ingelheim Investigational Site | Polva | |
| Estonia | Boehringer Ingelheim Investigational Site | Rakvere | |
| Estonia | Boehringer Ingelheim Investigational Site | Sillamae | |
| Estonia | Boehringer Ingelheim Investigational Site | Tallinn | |
| Estonia | Boehringer Ingelheim Investigational Site | Tartu | |
| Estonia | Boehringer Ingelheim Investigational Site | Viljandi | |
| Russian Federation | Boehringer Ingelheim Investigational Site | Bryansk | |
| Russian Federation | Boehringer Ingelheim Investigational Site | Dmitrov | |
| Russian Federation | Boehringer Ingelheim Investigational Site | Dolgoprudnii | |
| Russian Federation | Boehringer Ingelheim Investigational Site | Dzerzinsk | |
| Russian Federation | Boehringer Ingelheim Investigational Site | Gukovscii | |
| Russian Federation | Boehringer Ingelheim Investigational Site | Ivanovo | |
| Russian Federation | Boehringer Ingelheim Investigational Site | Moscow | |
| Russian Federation | Boehringer Ingelheim Investigational Site | Nijnii Novgorod | |
| Russian Federation | Boehringer Ingelheim Investigational Site | Nizhni Novgorod | |
| Russian Federation | Boehringer Ingelheim Investigational Site | Podolsk | |
| Russian Federation | Boehringer Ingelheim Investigational Site | Ryazan | |
| Russian Federation | Boehringer Ingelheim Investigational Site | Smolensk | |
| Russian Federation | Boehringer Ingelheim Investigational Site | Vladimir | |
| Russian Federation | Boehringer Ingelheim Investigational Site | Yaroslavl | |
| Slovakia | Boehringer Ingelheim Investigational Site | Bánovce/Bebravou | |
| Slovakia | Boehringer Ingelheim Investigational Site | Bardejov | |
| Slovakia | Boehringer Ingelheim Investigational Site | Bosany | |
| Slovakia | Boehringer Ingelheim Investigational Site | Bran? | |
| Slovakia | Boehringer Ingelheim Investigational Site | Handlová | |
| Slovakia | Boehringer Ingelheim Investigational Site | Humenné | |
| Slovakia | Boehringer Ingelheim Investigational Site | Kezmarok | |
| Slovakia | Boehringer Ingelheim Investigational Site | Kluknava | |
| Slovakia | Boehringer Ingelheim Investigational Site | Kosice | |
| Slovakia | Boehringer Ingelheim Investigational Site | Krompachy | |
| Slovakia | Boehringer Ingelheim Investigational Site | Liptovský Mikulás | |
| Slovakia | Boehringer Ingelheim Investigational Site | Malacky | |
| Slovakia | Boehringer Ingelheim Investigational Site | Martin | |
| Slovakia | Boehringer Ingelheim Investigational Site | Michalovce | |
| Slovakia | Boehringer Ingelheim Investigational Site | Námestovo | |
| Slovakia | Boehringer Ingelheim Investigational Site | Nitra | |
| Slovakia | Boehringer Ingelheim Investigational Site | Nove Mesto/Váhom | |
| Slovakia | Boehringer Ingelheim Investigational Site | Pies?any | |
| Slovakia | Boehringer Ingelheim Investigational Site | Poprad | |
| Slovakia | Boehringer Ingelheim Investigational Site | Presov | |
| Slovakia | Boehringer Ingelheim Investigational Site | Ruzomberok | |
| Slovakia | Boehringer Ingelheim Investigational Site | Se?ovská Polianka | |
| Slovakia | Boehringer Ingelheim Investigational Site | Senec | |
| Slovakia | Boehringer Ingelheim Investigational Site | Spisská Nová Ves | |
| Slovakia | Boehringer Ingelheim Investigational Site | St. ?ubov?a | |
| Slovakia | Boehringer Ingelheim Investigational Site | Stará Turá | |
| Slovakia | Boehringer Ingelheim Investigational Site | Stropkov | |
| Slovakia | Boehringer Ingelheim Investigational Site | Svinia | |
| Slovakia | Boehringer Ingelheim Investigational Site | Topo??any | |
| Slovakia | Boehringer Ingelheim Investigational Site | Torna?a | |
| Slovakia | Boehringer Ingelheim Investigational Site | Trebisov | |
| Slovakia | Boehringer Ingelheim Investigational Site | Tren?ín | |
| Slovakia | Boehringer Ingelheim Investigational Site | Trhoviste | |
| Slovakia | Boehringer Ingelheim Investigational Site | Vranov/Top?ou | |
| Slovakia | Boehringer Ingelheim Investigational Site | Vrútky | |
| Slovakia | Boehringer Ingelheim Investigational Site | Zilina |
| Lead Sponsor | Collaborator |
|---|---|
| Boehringer Ingelheim |
Croatia, Czech Republic, Estonia, Russian Federation, Slovakia,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Mean Change in Medical Outcomes Study 12-item Short-Form Health Survey, Version 2 Score From Baseline to Final Visit. | Physical Component Summary (PCS) Mean Difference final-baseline score. The Medical Outcomes Study 12-item Short-Form Health Survey, version 2 (SF-12v2) was used as the instrument to measure any changes in physical wellbeing (physical component summary, PCS) and mental wellbeing (mental component summary, MCS) in patients taking MOVALIS® therapy for approximately 4 weeks. Worst value 0 (lowest wellbeing), best value 100 (highest wellbeing) | baseline and final visit (approximately 4 weeks) | No |
| Primary | Mean Change in SF 12 MCS Score From Baseline to Final Final Visit.Medical Outcomes Study 12-Item Short-Form Health Survey, Version 2 | Mental Component Summary (MCS). Mean Difference final-baseline score. Worst value 0 (lowest wellbeing), best value 100 (highest wellbeing) | Baseline and final visit (approximately 4 weeks) | No |
| Secondary | Change From Baseline of Pain Intensity on Visual Analogue Scale | The effect of MOVALIS® on reduction of pain intensity was assessed by the change from baseline in patient assessment of pain intensity on a Visual Analogue Scale (VAS) ranging from 0 (no pain) to 100 (severe pain) | Approximately four weeks of treatment | No |
| Secondary | Patient Assessment of Efficacy | Patient assessment of general efficacy of MOVALIS® using a 5-point scale (1 excellent; 2 very good; 3 good; 4 fair; 5 poor) was performed at visit 2. The patients have been placed into categories according to the points on a scale. |
after approximately 4 weeks of treatment | No |
| Secondary | Physician Assessment of Efficacy | Physician assessment of general efficacy of MOVALIS® using a 5-point scale (1 excellent; 2 very good; 3 good; 4 fair; 5 poor) was performed at visit 2. The patients have been placed into categories according to the points on a scale. |
after approximately 4 weeks of treatment | No |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
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