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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)|
|Estimated 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|
|Primary Completion Date :||January 2005|
|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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|