Evaluation Of Fondaparinux (Also Called ARIXTRA) 2.5 mg Subcutaneously Once Daily For The Treatment Of Superficial Thrombophlebitis (Also Known As Superficial Vein Thrombosis)

Thrombosis, Venous Clinical Trial

Official title:

See Detailed Description

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00443053
• Other study ID #: ART108053
• Status: Completed
• Phase: Phase 3
• First received: March 2, 2007
• Last updated: February 18, 2016
• Start date: March 2007
• Est. completion date: July 2009

Study information

• Verified date: February 2013
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medicines Evaluation Board (MEB)
• Study type: Interventional

Clinical Trial Summary

To evaluate fondaparinux 2.5mg subcutaneously once daily for 45 days in the treatment of acute (recent) superficial thrombophlebitis.

Description:

Comparison of ARIXTRA™ in lower LImb Superficial Thrombophlebitis with placebo (CALISTO). An International, Multicentre, Randomised, Double-blind, Placebo-controlled, Two-parallel Group, Phase III Study to Evaluate the Efficacy and Safety of ARIXTRA (2.5 mg subcutaneously) for the Treatment of Patients with Acute Symptomatic Isolated Superficial Thrombophlebitis of the Lower Limbs to prevent Thromboembolic Complications

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3002
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Acute symptomatic superficial thrombophlebitis of the lower limbs at least 5 cm long diagnosed by compression ultrasound.

Exclusion criteria:

• Superficial thrombophlebitis that is within 3 cm from the sapheno-femoral junction,

• deep vein thrombosis on ultrasound exam, deep vein thrombosis or pulmonary embolism within last 6 months, treatment for cancer during last 6 months,

• anticoagulant medication for more than 48 hours prior to inclusion,

• need for oral non-steroidal anti-inflammatory drugs during the study, significant bleeding event during past month,

• major surgery within last 3 months, low platelet count (below 100×109/L),

• kidney disease (Calculated creatinine clearance < 30 mL/min), woman of child-bearing potential not using reliable contraceptive method

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Thrombophlebitis
• Thrombosis
• Thrombosis, Venous
• Venous Thrombosis

Intervention

Drug:
• Fondaparinux 2.5mg or placebo
Fondaparinux 2.5mg or matching placebo subcutaneously once daily up to day 45 day

Locations

Country	Name	City	State
Bulgaria	GSK Investigational Site	Sofia
Czech Republic	GSK Investigational Site	Brno
Czech Republic	GSK Investigational Site	Olomouc
Czech Republic	GSK Investigational Site	Plzen
Czech Republic	GSK Investigational Site	Praha 10
Czech Republic	GSK Investigational Site	Praha 10
Czech Republic	GSK Investigational Site	Praha 2
Czech Republic	GSK Investigational Site	Praha 4
Czech Republic	GSK Investigational Site	Praha 5
Czech Republic	GSK Investigational Site	Praha 6
Czech Republic	GSK Investigational Site	Ricany
Czech Republic	GSK Investigational Site	Tabor
Estonia	GSK Investigational Site	Saku
Estonia	GSK Investigational Site	Tallinn
Estonia	GSK Investigational Site	Tallinn
Estonia	GSK Investigational Site	Tartu
France	GSK Investigational Site	Abbeville
France	GSK Investigational Site	Ales
France	GSK Investigational Site	Amiens
France	GSK Investigational Site	Annecy
France	GSK Investigational Site	Annonay
France	GSK Investigational Site	Arras
France	GSK Investigational Site	Bordeaux
France	GSK Investigational Site	Brest
France	GSK Investigational Site	Clermont Ferrand
France	GSK Investigational Site	Grenoble
France	GSK Investigational Site	Montpellier
France	GSK Investigational Site	Nice
France	GSK Investigational Site	Nîmes Cedex 9
France	GSK Investigational Site	Saint Aubin sur Scie
France	GSK Investigational Site	Saint-Priest en Jarez
France	GSK Investigational Site	Tarbes
France	GSK Investigational Site	Toulon
France	GSK Investigational Site	Toulouse
France	GSK Investigational Site	Valenciennes
France	GSK Investigational Site	Villeurbanne
Germany	GSK Investigational Site	Altenburg	Thueringen
Germany	GSK Investigational Site	Augsburg	Bayern
Germany	GSK Investigational Site	Bad Bevensen	Niedersachsen
Germany	GSK Investigational Site	Baesweiler	Baden-Wuerttemberg
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Chemnitz	Sachsen
Germany	GSK Investigational Site	Dahlwitz-Hoppegarten	Brandenburg
Germany	GSK Investigational Site	Darmstadt	Hessen
Germany	GSK Investigational Site	Dresden	Sachsen
Germany	GSK Investigational Site	Eschwege	Hessen
Germany	GSK Investigational Site	Essen-Kettwig	Nordrhein-Westfalen
Germany	GSK Investigational Site	Frankenthal	Rheinland-Pfalz
Germany	GSK Investigational Site	Frankfurt	Hessen
Germany	GSK Investigational Site	Freiburg	Baden-Wuerttemberg
Germany	GSK Investigational Site	Grossheirath	Bayern
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Heidelberg	Baden-Wuerttemberg
Germany	GSK Investigational Site	Hemau	Bayern
Germany	GSK Investigational Site	Jena	Thueringen
Germany	GSK Investigational Site	Karlsbad	Baden-Wuerttemberg
Germany	GSK Investigational Site	Karlsruhe	Baden-Wuerttemberg
Germany	GSK Investigational Site	Kirchberg	Sachsen
Germany	GSK Investigational Site	Koeln	Nordrhein-Westfalen
Germany	GSK Investigational Site	Koeln-Junkersdorf	Nordrhein-Westfalen
Germany	GSK Investigational Site	Lauffen	Baden-Wuerttemberg
Germany	GSK Investigational Site	Leer	Niedersachsen
Germany	GSK Investigational Site	Leipzig	Sachsen
Germany	GSK Investigational Site	Ludwigshafen	Rheinland-Pfalz
Germany	GSK Investigational Site	Moenchengladbach	Nordrhein-Westfalen
Germany	GSK Investigational Site	Muehldorf	Bayern
Germany	GSK Investigational Site	Muenchen	Bayern
Germany	GSK Investigational Site	Muenchen	Bayern
Germany	GSK Investigational Site	Muenchen	Bayern
Germany	GSK Investigational Site	Neunkirchen	Saarland
Germany	GSK Investigational Site	Neuss	Nordrhein-Westfalen
Germany	GSK Investigational Site	Neustadt	Rheinland-Pfalz
Germany	GSK Investigational Site	Noerdlingen	Bayern
Germany	GSK Investigational Site	Nordhausen	Thueringen
Germany	GSK Investigational Site	Nuernberg	Bayern
Germany	GSK Investigational Site	Oberhausen	Nordrhein-Westfalen
Germany	GSK Investigational Site	Osnabrueck	Niedersachsen
Germany	GSK Investigational Site	Potsdam	Brandenburg
Germany	GSK Investigational Site	Rostock	Mecklenburg-Vorpommern
Germany	GSK Investigational Site	Waldbroel	Nordrhein-Westfalen
Germany	GSK Investigational Site	Wiesbaden	Hessen
Germany	GSK Investigational Site	Wuerzburg	Bayern
Germany	GSK Investigational Site	Wuppertal	Nordrhein-Westfalen
Greece	GSK Investigational Site	Alexandroupolis
Greece	GSK Investigational Site	Athens
Greece	GSK Investigational Site	Athens
Greece	GSK Investigational Site	Heraklion
Greece	GSK Investigational Site	Larisa
Greece	GSK Investigational Site	Melissia Athens
Greece	GSK Investigational Site	Thessaloniki
Greece	GSK Investigational Site	Thessaloniki
Hungary	GSK Investigational Site	Bekescsaba
Hungary	GSK Investigational Site	Budapest
Hungary	GSK Investigational Site	Budapest
Hungary	GSK Investigational Site	Budapest
Hungary	GSK Investigational Site	Budapest
Hungary	GSK Investigational Site	Budapest
Hungary	GSK Investigational Site	Budapest
Hungary	GSK Investigational Site	Budapest
Hungary	GSK Investigational Site	Debrecen
Hungary	GSK Investigational Site	Esztergom
Hungary	GSK Investigational Site	Gyula
Hungary	GSK Investigational Site	Kaposvár
Hungary	GSK Investigational Site	Miskolc
Hungary	GSK Investigational Site	Nyiregyháza
Hungary	GSK Investigational Site	Pécs
Hungary	GSK Investigational Site	Székesfehérvár
Hungary	GSK Investigational Site	Szikszó
Hungary	GSK Investigational Site	Zalaegerszeg
Israel	GSK Investigational Site	Afula
Israel	GSK Investigational Site	Ashkelon
Israel	GSK Investigational Site	Haifa
Israel	GSK Investigational Site	Kfar Saba
Israel	GSK Investigational Site	Petach Tikva
Israel	GSK Investigational Site	Safed
Israel	GSK Investigational Site	Tel-Aviv
Italy	GSK Investigational Site	Chieti Scalo	Abruzzo
Italy	GSK Investigational Site	Firenze	Toscana
Italy	GSK Investigational Site	Milano	Lombardia
Italy	GSK Investigational Site	Milano	Lombardia
Italy	GSK Investigational Site	Milano	Lombardia
Italy	GSK Investigational Site	Napoli	Campania
Italy	GSK Investigational Site	Padova	Veneto
Italy	GSK Investigational Site	Palermo	Sicilia
Italy	GSK Investigational Site	Pavia	Lombardia
Italy	GSK Investigational Site	Piacenza	Emilia-Romagna
Italy	GSK Investigational Site	Reggio Emilia	Emilia-Romagna
Italy	GSK Investigational Site	Rimini	Emilia-Romagna
Italy	GSK Investigational Site	Venezia	Veneto
Latvia	GSK Investigational Site	Daugavpils
Latvia	GSK Investigational Site	Riga
Latvia	GSK Investigational Site	Riga
Latvia	GSK Investigational Site	Riga
Netherlands	GSK Investigational Site	Alkmaar
Netherlands	GSK Investigational Site	Amsterdam
Netherlands	GSK Investigational Site	Amsterdam
Netherlands	GSK Investigational Site	Den Haag
Netherlands	GSK Investigational Site	Maastricht
Netherlands	GSK Investigational Site	Weerselo
Poland	GSK Investigational Site	Bialystok
Poland	GSK Investigational Site	Bydgoszcz
Poland	GSK Investigational Site	Gniewkowo
Poland	GSK Investigational Site	Grudziadz
Poland	GSK Investigational Site	Poznan
Poland	GSK Investigational Site	Wroclaw
Russian Federation	GSK Investigational Site	Arkhangelsk
Russian Federation	GSK Investigational Site	Barnaul
Russian Federation	GSK Investigational Site	Ekaterinburg
Russian Federation	GSK Investigational Site	Ekaterinburg
Russian Federation	GSK Investigational Site	Irkutsk
Russian Federation	GSK Investigational Site	Kemerovo
Russian Federation	GSK Investigational Site	Kursk
Russian Federation	GSK Investigational Site	Lipetsk
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	Perm
Russian Federation	GSK Investigational Site	Perm
Russian Federation	GSK Investigational Site	Rostov-na-Donu
Russian Federation	GSK Investigational Site	Ryazan
Russian Federation	GSK Investigational Site	Saint-Petersburg
Russian Federation	GSK Investigational Site	Saint-Petersburg
Russian Federation	GSK Investigational Site	Samara
Russian Federation	GSK Investigational Site	Saratov
Russian Federation	GSK Investigational Site	St. Petersburgh
Russian Federation	GSK Investigational Site	Stavropol
Russian Federation	GSK Investigational Site	Tomsk
Russian Federation	GSK Investigational Site	Tomsk
Russian Federation	GSK Investigational Site	Tumen
Russian Federation	GSK Investigational Site	Ufa
Russian Federation	GSK Investigational Site	Voronezh
Russian Federation	GSK Investigational Site	Yaroslavl
Russian Federation	GSK Investigational Site	Yaroslavl
Slovakia	GSK Investigational Site	Bardejov
Slovakia	GSK Investigational Site	Bratislava
Slovakia	GSK Investigational Site	Bratislava
Slovakia	GSK Investigational Site	Kosice
Slovakia	GSK Investigational Site	Kosice
Slovakia	GSK Investigational Site	Nitra
Slovakia	GSK Investigational Site	Presov
Slovakia	GSK Investigational Site	Zilina
Spain	GSK Investigational Site	Avila
Spain	GSK Investigational Site	Boadilla del Monte (Madrid)
Spain	GSK Investigational Site	Cartagena (Murcia)
Spain	GSK Investigational Site	Getafe
Spain	GSK Investigational Site	Gijon
Spain	GSK Investigational Site	Hospitalet de Llobregat
Spain	GSK Investigational Site	Marid
Spain	GSK Investigational Site	Mataro
Spain	GSK Investigational Site	Palma de Mallorca
Spain	GSK Investigational Site	Sabadell (Barcelona)
Spain	GSK Investigational Site	San Juan De Alicante
Spain	GSK Investigational Site	Segovia
Spain	GSK Investigational Site	Valencia
Spain	GSK Investigational Site	Valladolid
Spain	GSK Investigational Site	Zamora
Switzerland	GSK Investigational Site	Bern
Switzerland	GSK Investigational Site	Bruderholz
Switzerland	GSK Investigational Site	Fribourg
Switzerland	GSK Investigational Site	Geneve
Switzerland	GSK Investigational Site	Lausanne
Switzerland	GSK Investigational Site	Luzern
Switzerland	GSK Investigational Site	Zuerich
Ukraine	GSK Investigational Site	Dnipropetrovsk
Ukraine	GSK Investigational Site	Dnipropetrovsk
Ukraine	GSK Investigational Site	Donetsk
Ukraine	GSK Investigational Site	Ivano-Frankivsk
Ukraine	GSK Investigational Site	Kharkiv
Ukraine	GSK Investigational Site	Kyiv
Ukraine	GSK Investigational Site	Kyiv
Ukraine	GSK Investigational Site	Kyiv
Ukraine	GSK Investigational Site	Lviv
Ukraine	GSK Investigational Site	Sevastopol
Ukraine	GSK Investigational Site	Uzhgorod
Ukraine	GSK Investigational Site	Vinnitsa
Ukraine	GSK Investigational Site	Zaporizhzhya
Ukraine	GSK Investigational Site	Zaporizhzhya
Ukraine	GSK Investigational Site	Zaporizhzhya

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Bulgaria,  Czech Republic,  Estonia,  France,  Germany,  Greece,  Hungary,  Israel,  Italy,  Latvia,  Netherlands,  Poland,  Russian Federation,  Slovakia,  Spain,  Switzerland,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With at Least on Event of Venous Thromboembolism (VTE) and/or Death From Any Cause Recorded up to Day 47	VTE was defined as a composite of symptomatic deep-vein thrombosis (DVT), symptomatic pulmonary embolism (PE), symptomatic extension of superficial vein thrombosis (SVT), or symptomatic recurrence of SVT. All VTEs were confirmed by objective tests and then adjudicated by an independent central adjudication committee (CAC), whose members were blinded to treatment assignment.	Baseline to Day 47	No
Secondary	Number of Participants With at Least One Event of Venous Thromboembolism (VTE) and/or Death From Any Cause Recorded up to Day 77	VTE was defined as a composite of symptomatic deep-vein thrombosis (DVT), symptomatic pulmonary embolism (PE), symptomatic extension of superficial vein thrombosis (SVT), or symptomatic recurrence of SVT. All VTEs were confirmed by objective tests and then adjudicated by an independent central adjudication committee (CAC), whose members were blinded to treatment assignment.	Baseline to Day 77	No
Secondary	Number of Participants With at Least One Occurrence of Each Adjudicated Component of the Primary Efficacy Endpoint at Days (D) 47 and 77	VTE was defined as a composite of symptomatic DVT; symptomatic PE; symptomatic extension of SVT, defined as downstream progression of the initial SVT by at least 2 cm and to within <=3 cm from the sapheno-femoral junction; or symptomatic recurrence of SVT, defined as a new episode in any other superficial venous location, meeting the following criteria: the new SVT was in a different superficial vein and not directly contiguous upstream with the index SVT, or it was in the same superficial vein but clearly distinct from the index SVT with an open venous segment of at least 10 cm in length.	Days 47 and 77	No
Secondary	Number of Participants Who Required Surgery to Treat Superficial Vein Thrombosis Recurrence at Days 47 and 77	The number of participants requiring surgery was measured.	Days 47 and 77	No
Secondary	Number of Adjudicated Major Bleeding Events and Deaths at Days 47 and 77	Major bleeding was defined as bleeding that was fatal and/or (1) in a critical area/organ (e.g., intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome); (2) associated with a fall in hemoglobin >=20 g/L (1.24 mmol/L); (3) led to a transfusion of >=2 units of packed red blood cells/whole blood. The revision of the Day 47 time point was to account for participants with treatment duration longer than 45 days. Adverse events were evaluated "On-Treatment," defined as from randomization up to the last injection +4 days.	Days 47 (or last dose plus 4 days) and 77	No
Secondary	Number of Adjudicated Non-Major Bleeding Events at Days 47 and 77	Clinically relevant non-major bleeding was defined as clinically relevant bleeding that did not qualify as major but satisfied a priori criteria, and/or any bleeding that resulted in clinical consequences for a participant. The revision of the Day 47 time point was to account for participants with treatment duration longer than 45 days. Adverse events were evaluated "On-Treatment," defined as from randomization up to the last injection +4 days.	Days 47 (or last dose plus 4 days) and 77	No
Secondary	Number of Any Adjudicated Bleeding Events at Days 47 and 77	The sum of adjudicated major bleeds, non-major clinically relevant bleeds, and minor bleeds was calculated. Minor bleeding was defined as other clinically overt bleeding events that did not meet the criteria for major or clinically relevant non-major bleeding. The revision of the Day 47 time point was to account for participants with treatment duration longer than 45 days. Adverse events were evaluated "On-Treatment," defined as from randomization up to the last injection +4 days.	Days 47 (or last dose plus 4 days) and 77	No