NCT00251914CompletedPhase 3
Supportive Test for Acid-Related Symptoms (STARS I) With Esomeprazole and a Following 7-week, Double-blind, Randomized, Placebo Controlled Treatment Period in Subjects With Upper Gastrointestinal Symptoms and With Normal Findings at Esophagogastroduodenoscopy.
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- AstraZeneca
- Enrollment
- 1,500
- Locations
- 215
- Primary Endpoint
- The primary outcome is whether the patient is a responder or not after 8 weeks treatment.
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •At least 3 months of symptoms of pain or burning centered in the upper abdomen prior to enrollment.
- •Both Helicobacter pylori positive and negative patients eligible (Helicobacter pylori is a bacterial infection of the stomach)
Exclusion Criteria
- •Presence of clinical significant abnormal findings at the endoscopy (examination of esophagus and stomach) prior to enrollment.
- •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.
Outcomes
Primary Outcomes
The primary outcome is whether the patient is a responder or not after 8 weeks treatment.
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 primary efficacy outcome is based on symptom score recorded daily during the study in a patient diary.
Secondary Outcomes
- Presence/absence of specific GI symptoms after 4 and 8 weeks of therapy
- 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,
Investigators
Study Sites (215)
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