Clinical Trial: Efficacy of Esomeprazole in Patients With Frequent Heartburn

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase III Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial of 14 Day Treatment With Esomeprazole 20 mg Once Daily in Subjects With Frequent Hear

Brief Summary: This study will investigate the efficacy of esomeprazole 20 mg once a day in the treatment of frequent heartburn

Detailed Summary:
Sponsor: AstraZeneca

Current Primary Outcome:

• Percentage of Heartburn Free 24 Hour Days During 14 Days of Randomized Treatment [ Time Frame: From randomisation to day 14 ]
• Percentage of Heartburn Free 24 Hour Days During 14 Days of Randomized Treatment [ Time Frame: From randomization to day 14 ]

Original Primary Outcome: Determine efficacy during free 24-hour days during 14 days of treatment [ Time Frame: During 2 weeks of treatment ]

Current Secondary Outcome:

• Number of Subjects Reporting Heartburn 2 Days or Less During the 14 Days Randomized Treatment Period [ Time Frame: From randomisation to day 14 ]
  Randomized treatment period is considered as both weeks 1 and 2 between V3 and V4.
• Comparison of Number of Subjects With 0, 1, 2, 3 or 4 Days With no Heartburn Over Days 1 to 4 Between Esomeprazole 20 mg and Placebo [ Time Frame: From randomisation to the day 14 ]
  The first 4 consecutive days subjects were on randomized treatment, between V3 and V4.
• Number of Subjects With Heartburn 1 Day or Less During the Final Week, Second Week, First Week of Treatment [ Time Frame: From randomisation to day 14 ]
  There were three separate 7 day time periods during the treatment period; The first week (days 1-7), the second week (days 8-14), and the last 7 consecutive days (last day subject reported and the prior 6). For a given subject, the second week and last 7 consecutive days are the same if the subject has recorded measurements for the entire 14 day treatment period. However, for subjects reporting anything less than 14 days the two will not be identical. For all three 7 day time periods, days when a subject did not call in (i.e., missing values) were imputed as a day with heartburn.

Original Secondary Outcome:

• Determine proportion of subjects during the final week of treatment [ Time Frame: During last 7 days of the 2 week treatment ]
  Determine the proportion of subjects with resolution of frequent heartburn as defined by a subject reporting 1 day of heartburn or less during the final week of treatment.
• Determine efficacy over days 1-4 [ Time Frame: During first 4 days of the 2 week treatment ]
  Determine efficacy of esomeprazole 20 mg daily for the treatment of frequent heartburn by the proportion of days with no heartburn over days 1-4.

Dates:
Date Received: June 1, 2011
Date Started: August 2011
Date Completion:
Last Updated: February 12, 2013
Last Verified: February 2013