Esomeprazole for Relief of Upper Gastrointestinal Symptoms Associated With Continuous Use of NSAIDs

Phase 3

Completed

• Conditions: NSAIDs; Upper GI Symptoms

• Registration Number: NCT00241527
• Lead Sponsor: AstraZeneca

Brief Summary

This study was a randomised, double-blind, parallel-group and placebo controlled study comparing the efficacy of esomeprazole 40 mg orally qd vs placebo and esomeprazole 20 mg orally qd vs placebo when given to patients on continuous use of NSAIDs, including COX-2 selective NSAIDs, for a treatment period of 4 weeks for relief of upper GI symptoms.

Detailed Description

Not available

Study Timeline

• Study Start: 2000-12
• Primary Completion: 2002-09
• Study Completion: 2002-09
• Study First Submitted: 2005-10-18
• Study First Submitted QC: 2005-10-18
• Study First Posted: 2005-10-19
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-21
• Last Update Posted: 2011-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 556

Inclusion Criteria

• Signed informed consent.
• 18 years of age, or older.
• Capable of completing the diary card.
• Ability to complete the HRQL questionnaires.
• A clinical diagnosis of a chronic condition (e.g., osteoarthritis or rheumatoid arthritis) that requires continuous daily NSAID treatment for at least 7 months. Daily NSAID treatment is defined as taking the prescribed dose for at least 5 of 7 days in any given week and can include COX-2 selective NSAIDs, multiple NSAIDs, and high-dose aspirin (>325 mg/day).
• Daily NSAID treatment dose and type: (Must have been stable for at least 4 weeks prior to baseline endoscopy and; Are expected to remain stable for the duration of the study. and; Must be administered orally for the duration of the study. If more than one type of NSAID treatment is used, at least one type must be given orally.)
• Hp negative by UBT, serology or biopsy based test, at visit 1.

Exclusion Criteria

• Current, or history of, gastric or duodenal ulcer
• Current, or history of, esophageal, gastric or duodenal surgery.
• History of GERD, not associated with NSAID use.
• Pain, discomfort or burning in the upper abdomen precipitated by exercise or relieved by defecation.
• Pain, discomfort or burning in the upper abdomen not associated with the use of NSAIDs, including COX-2 selective NSAIDs, as judged by the investigator.
• Endoscopic Barrett's esophagus(>3 cm) or significant dysplastic changes in the esophagus.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Mean change in the upper GI symptoms (pain, discomfort or
burning in the upper abdomen), rated on a 7-graded severity scale

Secondary Outcome Measures

Name	Time	Method
- Mean change in the upper GI symptom score
- The proportion of days with an upper GI symptom score of 'None' at 2 and 4 weeks of treatment.
- Mean upper GI symptom score by day over the duration of the study.
- Cumulative proportion of patients who achieve relief of upper GI symptoms by Week 2 and Week 4.
- Proportions of patients with upper GI symptoms during night, over the duration of the study.
- The proportion of patients with resolution or relief of investigator-recorded symptoms of heartburn, acid regurgitation, nausea & upper abdominal bloating at the 2-week, and 4-week visits.
- The mean change in the three dimensions Reflux, Abdominal pain and Indigestion of the Gastrointestinal Symptom Rating Scale (GSRS)
- Mean change in the three dimensions Emotional distress, Sleep disturbance and Food/Drink problems
- Patient's global evaluation of relief of upper GI symptom (Overall Treatment Evaluation, OTE) at the 2-week, and 4-week visits.
-Short Form-36 (SF-36) score at baseline.

Trial Locations

Locations (2)

Research Site; 🇬🇧 Yoxall, United Kingdom

Sweden; 🇸🇪 Gävle, Sweden