Dyspepsia Clinical Trial
Official title:
Supportive Test for Acid-Related Symptoms (STARS II) With Esomeprazole and a Following 7-week, Double-blind, Randomized, Placebo Controlled Treatment Period in Uninvestigated Subjects With Upper Gastrointestinal Symptoms.
Verified date | January 2011 |
Source | AstraZeneca |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Health Canada |
Study type | Interventional |
The aim is to evaluate if the resolution of upper abdominal symptoms (pain or burning) during an acid suppressive test trial of esomprazole given daily for 7 days predicts symptoms resolution at the end of a subsequent treatment period of 7 weeks.
Status | Completed |
Enrollment | 1200 |
Est. completion date | January 2005 |
Est. primary completion date | January 2005 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 50 Years |
Eligibility |
Inclusion Criteria: - At least 3 months of symptoms of pain or burning centered in the upper abdomen prior to enrollment. - Helicobacter pylori test performed at enrollment must be negative (Helicobacter pylori is a bacterial infection of the stomach). Exclusion Criteria: - Patients with symptoms of other gastrointestinal diseases, such as Gastroesophageal Reflux Disease (GERD), Irritable Bowel Syndrome (IBS) or Inflammatory Bowel Disease (IBD). - Helicobacter pylori eradication treatment during the last 12 months prior to enrollment. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Austria | Research Site | Braunau | |
Austria | Research Site | Graz | |
Austria | Research Site | Krems | |
Austria | Research Site | Linz | |
Austria | Research Site | Salzburg | |
Austria | Research Site | Sankt Pölten | |
Austria | Research Site | St. Johann | |
Austria | Research Site | Wien | |
Austria | Research Site | Wiener Neustadt | |
Austria | Research Site | Zell am See | |
Belgium | Research Site | Ans | |
Belgium | Research Site | Brussels (Uccle) | |
Belgium | Research Site | Gozée | |
Belgium | Research Site | Halle | |
Belgium | Research Site | Kontich | |
Belgium | Research Site | Kortenberg | |
Belgium | Research Site | Kraainem | |
Belgium | Research Site | Liège | |
Belgium | Research Site | Linkebeek | |
Belgium | Research Site | Massemen | |
Belgium | Research Site | Moerkerke | |
Belgium | Research Site | Natoye | |
Belgium | Research Site | Oud-Heverlee | |
Belgium | Research Site | Saint-Médard | |
Belgium | Research Site | Soignies | |
Belgium | Research Site | Waremme | |
Belgium | Research Site | Wezembeek- Oppem | |
Belgium | Research Site | Wingene | |
Belgium | Research Site | Zoersel | |
Belgium | Research Site | Zolder | |
Belgium | Research Site | Zonhoven | |
Canada | Research Site | Ajax | Ontario |
Canada | Research Site | Bay Roberts | Newfoundland and Labrador |
Canada | Research Site | Brampton | Ontario |
Canada | Research Site | Burlington | Ontario |
Canada | Research Site | Calgary | Alberta |
Canada | Research Site | Charlesbourg | Quebec |
Canada | Research Site | Charlottetown | Prince Edward Island |
Canada | Research Site | Dorchester | Ontario |
Canada | Research Site | Edmonton | Alberta |
Canada | Research Site | Elmsdale | Nova Scotia |
Canada | Research Site | Granby | Quebec |
Canada | Research Site | Halifax | Nova Scotia |
Canada | Research Site | Hamilton | Ontario |
Canada | Research Site | Kanata | Ontario |
Canada | Research Site | Kelowna | British Columbia |
Canada | Research Site | Kitchener | Ontario |
Canada | Research Site | London | Ontario |
Canada | Research Site | Markham | Ontario |
Canada | Research Site | Mississauga | Ontario |
Canada | Research Site | Niagara Falls | Ontario |
Canada | Research Site | North York | Ontario |
Canada | Research Site | Orleans | Ontario |
Canada | Research Site | Oshawa | Ontario |
Canada | Research Site | Ottawa | Ontario |
Canada | Research Site | Parkdale | Prince Edward Island |
Canada | Research Site | Penticton | British Columbia |
Canada | Research Site | Richmond Hill | Ontario |
Canada | Research Site | Saint-Leonard | Quebec |
Canada | Research Site | Sainte Gedeon-de-Beauce | Ontario |
Canada | Research Site | Sainte-Foy | Quebec |
Canada | Research Site | Scarborough | Ontario |
Canada | Research Site | St Catherines | Ontario |
Canada | Research Site | St. John's | Newfoundland and Labrador |
Canada | Research Site | Stirling | Ontario |
Canada | Research Site | Thunder Bay | Ontario |
Canada | Research Site | Toronto | Ontario |
Canada | Research Site | Tottenham | Ontario |
Canada | Research Site | Whitby | Ontario |
Canada | Research Site | Winnipeg | Manitoba |
Finland | Research Site | Espoo | |
Finland | Research Site | Helsinki | |
Finland | Research Site | Kouvola | |
Finland | Research Site | Lempäälä | |
Finland | Research Site | Pirkkala | |
Finland | Research Site | Pori | |
Finland | Research Site | Sahalahti | |
Finland | Research Site | Tampere | |
Finland | Research Site | Vääksy | |
France | Research Site | Angers | |
France | Research Site | Dambach La Ville | |
France | Research Site | Dijon | |
France | Research Site | La Seyne Sur Mer | |
France | Research Site | Laxou | |
France | Research Site | Louviers | |
France | Research Site | MONT DE MARSAN Cedex | |
France | Research Site | NANCY Cedex | |
France | Research Site | Saint-ouen | |
France | Research Site | Vieux Conde | |
Germany | Research Site | Lochham | |
Germany | Research Site | München | |
Germany | Research Site | Rödental | |
Hungary | Research Site | Budaörs | |
Hungary | Research Site | Budapest | |
Hungary | Research Site | Esztergom | |
Hungary | Research Site | Hatvan | |
Hungary | Research Site | Nagykanizsa | |
Hungary | Research Site | Siófok | |
Hungary | Research Site | Tát | |
Hungary | Research Site | Zalaegerszeg | |
Mexico | Research Site | Culiacán | |
Mexico | Research Site | Guadalajara | |
Mexico | Research Site | León | |
Mexico | Research Site | Mexico | D.F |
Mexico | Research Site | México | |
Mexico | Research Site | Torreón | |
Norway | Research Site | Bekkestua | |
Norway | Research Site | Bergen | |
Norway | Research Site | Hønefoss | |
Norway | Research Site | Lier | |
Norway | Research Site | Lysaker | |
Norway | Research Site | Moss | |
Norway | Research Site | Oslo | |
Norway | Research Site | Østerås | |
Norway | Research Site | Paradis | |
Norway | Research Site | Rådal | |
Norway | Research Site | Rykkinn | |
Norway | Research Site | Sandefjord | |
Norway | Research Site | Skien | |
Norway | Research Site | Søgne | |
Norway | Research Site | Tvedestrand | |
South Africa | Research Site | Bloemfontein | |
South Africa | Research Site | Boksburg | |
South Africa | Research Site | Cape Town | |
South Africa | Research Site | Durban | |
South Africa | Research Site | Halfway House | |
South Africa | Research Site | Lenasia | Gauteng |
South Africa | Research Site | Lyttelton Manor | |
South Africa | Research Site | Pretoria | |
Sweden | Research Site | Ängelholm | |
Sweden | Research Site | Fritsla | |
Sweden | Research Site | Göteborg | |
Sweden | Research Site | Halmstad | |
Sweden | Research Site | Höganäs | |
Sweden | Research Site | Ingelstad | |
Sweden | Research Site | Jönköping | |
Sweden | Research Site | Kalmar | |
Sweden | Research Site | Kilafors | |
Sweden | Research Site | Kristinehamn | |
Sweden | Research Site | Kungsör | |
Sweden | Research Site | Motala | |
Sweden | Research Site | Munkedal | |
Sweden | Research Site | Nässjö | |
Sweden | Research Site | Norrtälje | |
Sweden | Research Site | Rättvik | |
Sweden | Research Site | Staffanstorp | |
Sweden | Research Site | Sundsbruk | |
Sweden | Research Site | Trollhättan | |
Sweden | Research Site | Uddevalla | |
Sweden | Research Site | Upplands Väsby | |
Sweden | Research Site | Vällingby | |
Sweden | Research Site | Västerås | |
Sweden | Research Site | Växjö | |
Switzerland | Research Site | Aarau | |
Switzerland | Research Site | Brittnau | |
Switzerland | Research Site | Egg bei Zürich | Zürich |
Switzerland | Research Site | Küttigen | |
Switzerland | Research Site | Schaffhausen | |
Switzerland | Research Site | Schönbühl-Urtenen | Bern |
Switzerland | Research Site | Winterthur | Zürich |
Switzerland | Research Site | Zürich | |
United Kingdom | Research Site | Audley | |
United Kingdom | Research Site | Blackburn | |
United Kingdom | Research Site | Blackpool | |
United Kingdom | Research Site | Chesterfield | |
United Kingdom | Research Site | Coventry | |
United Kingdom | Research Site | Ely | Cambridgeshire |
United Kingdom | Research Site | Enfield | |
United Kingdom | Research Site | Glasgow | |
United Kingdom | Research Site | Hadleigh | |
United Kingdom | Research Site | Harrow | |
United Kingdom | Research Site | Irvine | |
United Kingdom | Research Site | Mansfield | |
United Kingdom | Research Site | Nottingham | |
United Kingdom | Research Site | Sheffield | |
United Kingdom | Research Site | Shrewsbury | |
United Kingdom | Research Site | Slough | |
United Kingdom | Research Site | Titchfield | |
United Kingdom | Research Site | Tonbridge | |
United Kingdom | Research Site | Tunbridge Wells | |
United Kingdom | Research Site | Watford | |
United Kingdom | Research Site | Woking | Surrey |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca |
Austria, Belgium, Canada, Finland, France, Germany, Hungary, Mexico, Norway, South Africa, Sweden, Switzerland, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The primary outcome is whether the patient is a responder or not after 8 weeks treatment. | |||
Primary | The primary efficacy outcome is based on symptom score recorded daily during the study in a patient diary. | |||
Primary | The patient will judge their symptoms of pain or burning centered in the upper abdomen on a four-graded scale (none, mild, moderate or severe). | |||
Secondary | The secondary efficacy outcomes are whether the patient is a responder or not after 4 weeks, | |||
Secondary | The average symptom score and the percentage of symptom-free days during the 7-week treatment period, | |||
Secondary | Presence/absence of specific GI symptoms after 4 and 8 weeks of therapy |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06094062 -
Smartphone App-assisted PPI
|
N/A | |
Completed |
NCT03941288 -
Efficacy and Safety of Cannabidiol for Gastroparesis and Functional Dyspepsia
|
Phase 2 | |
Completed |
NCT04429802 -
The Effect of Prucalopride (Resolor®) on Gastric Motor Function and Gastric Sensitivity
|
N/A | |
Not yet recruiting |
NCT06369753 -
Visible Abdominal Distension
|
N/A | |
Withdrawn |
NCT02863822 -
Study to Evaluate Dietary Modification in Patients With Functional Dyspepsia.
|
N/A | |
Recruiting |
NCT00978159 -
Esomeprazole or Famotidine in the Management of Aspirin Related Non-Ulcer Dyspepsia
|
Phase 4 | |
Completed |
NCT00723502 -
Efficacy and Safety Study of Finafloxacin Used in Helicobacter Pylori Infected Patients
|
Phase 2 | |
Completed |
NCT00148603 -
Montelukast in the Treatment of Duodenal Eosinophilia
|
N/A | |
Completed |
NCT00217347 -
Evaluation of Efficiency of Esophageal Capsule Endoscopy in the Screening of Patients With Gastroesophageal Reflux Disease or Dyspepsia as Compared to Upper Endoscopy
|
N/A | |
Terminated |
NCT00220844 -
Tricyclic Antidepressants (TCAs) on Gastric Emptying
|
N/A | |
Completed |
NCT00232102 -
Extension Study to Assess the Long-Term Safety of Tegaserod in Women With Symptoms of Dyspepsia
|
Phase 3 | |
Completed |
NCT00232037 -
Extension Study to Assess the Long-Term Safety of Tegaserod in Women With Symptoms of Dyspepsia
|
Phase 3 | |
Completed |
NCT00164996 -
Ultrathin Versus Conventional Esophagogastroduodenoscopy in Unsedated Patient With or Without Local Pharyngeal Anaesthesia
|
Phase 3 | |
Completed |
NCT00110968 -
Long-term Safety and Efficacy of Itopride Hydrochloride (HCl) in Patients Suffering From Functional Dyspepsia
|
Phase 3 | |
Recruiting |
NCT05718960 -
Traditional Dietary Advice Versus Reassurance-alone in Postprandial Functional Dyspepsia
|
N/A | |
Completed |
NCT05750641 -
The Efficacy of Removal of Animal Milk From the Diet in Functional Dyspepsia: A Cross-sectional Study
|
||
Terminated |
NCT04247100 -
A Study of Randomized Sham-control Auricular TENS Unit Stimulation in Pediatric Functional Gastrointestinal Disorders
|
N/A | |
Completed |
NCT04697641 -
Helicobacter Pylori Eradication in Functional Dyspepsia
|
N/A | |
Completed |
NCT03252743 -
ICBT for Pain-predominant FGIDs in Children and Adolescents: an Implementation Study.
|
N/A | |
Recruiting |
NCT04918329 -
Functional Digestive Disorders Observatory
|