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|ClinicalTrials.gov Identifier: NCT00251992|
Recruitment Status : Completed
First Posted : November 11, 2005
Last Update Posted : January 24, 2011
|Condition or disease||Intervention/treatment||Phase|
|Gastrointestinal Disease Signs and Symptoms, Digestive Dyspepsia||Drug: Esomeprazole||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||1200 participants|
|Intervention Model:||Parallel Assignment|
|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.|
|Study Start Date :||December 2002|
|Actual Primary Completion Date :||January 2005|
|Actual Study Completion Date :||January 2005|
- The primary outcome is whether the patient is a responder or not after 8 weeks treatment.
- The primary efficacy outcome is based on symptom score recorded daily during the study in a patient diary.
- 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).
- The secondary efficacy outcomes are whether the patient is a responder or not after 4 weeks,
- The average symptom score and the percentage of symptom-free days during the 7-week treatment period,
- Presence/absence of specific GI symptoms after 4 and 8 weeks of therapy
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00251992
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|Study Director:||AstraZeneca Nexium Medical Sciences Director, MD||AstraZeneca|