Nexium Dyspepsia/AST
Phase 3
Completed
- Conditions
- Gastrointestinal DiseaseSigns and Symptoms, DigestiveDyspepsia
- Registration Number
- NCT00251992
- Lead Sponsor
- AstraZeneca
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1200
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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).
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Research Site
🇬🇧Watford, United Kingdom