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.
Signs and Symptoms, Digestive
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|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.|
- 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
|Study Start Date:||December 2002|
|Study Completion Date:||January 2005|
|Primary Completion Date:||January 2005 (Final data collection date for primary outcome measure)|
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|Study Director:||AstraZeneca Nexium Medical Sciences Director, MD||AstraZeneca|