Clinical Trial: Acid-Associated Heartburn Symptoms and Dose of Esomeprazole
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A 4-week Study to Investigate the Relationship Between Resolution of Acid-Associated Heartburn Symptoms and Dose of Esomeprazole Magnesium
Brief Summary: This is a multi-center, double-blind, parallel-group, randomized, proof of concept trial to investigate the relationship between dose of esomeprazole magnesium and acid-associated heartburn symptoms during 4 weeks of treatment. The safety and tolerability of esomeprazole magnesium in doses up to 40 mg BID will also be assessed.
Detailed Summary:
Sponsor: AstraZeneca
Current Primary Outcome: Sustained resolution of heartburn during the 4th week of treatment, defined as 7 consecutive days with a daily e-diary heartburn assessment of "None".
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Relief of heartburn during the 4th week of treatment
- Cumulative daily sustained resolution rate through 4 weeks of treatment
- Time to first day of the first 7-day period of sustained resolution of heartburn
- Time to the first day of the first 7-day period of relief of heartburn
- Percentage of subject-reported heartburn-free days through 4 weeks of treatment
- Percentage of subject-reported heartburn-free nights through the 4 weeks of treatment
- Safety and tolerability: adverse events, clinical laboratory tests, vital signs, physical examination.
Original Secondary Outcome: Same as current
Information By: AstraZeneca
Dates:
Date Received: September 12, 2005
Date Started: November 2004
Date Completion:
Last Updated: November 18, 2010
Last Verified: November 2010
