Comparing the Efficacy, Safety, and Tolerability of Rabeprazole ER 50 mg With Placebo in Subjects With Symptomatic Gastroesophageal Reflux Disease (sGERD)
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|ClinicalTrials.gov Identifier: NCT00911534|
Recruitment Status : Completed
First Posted : June 2, 2009
Results First Posted : February 2, 2016
Last Update Posted : February 2, 2016
|Condition or disease||Intervention/treatment||Phase|
|Symptomatic Gastroesophageal Reflux Disease (sGERD)||Drug: rabeprazole sodium Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||305 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Multicenter Randomized Double-Blind Study to Compare the Efficacy, Safety, and Tolerability of Rabeprazole ER 50 mg With Placebo in Subjects With Symptomatic Gastroesophageal Reflux Disease (sGERD)|
|Study Start Date :||January 2009|
|Actual Primary Completion Date :||July 2009|
|Actual Study Completion Date :||October 2009|
Drug: rabeprazole sodium
One rabeprazole extended release (ER) 50 mg capsule daily; rescue medication will be provided to subjects to take as needed.
Other Name: rabeprazole sodium extended release
|Placebo Comparator: 2||
One rabeprazole placebo capsule daily; rescue medication will be provided to subjects to take as needed.
- Mean Percentage of Diary-Recorded Heartburn-Free Days at Week 4 [ Time Frame: Week 4 ]Participants completed a daily symptom diary. A heartburn-free day was defined as participant report of 'No Heartburn' from nighttime and daytime of the diary for the same day.
- Change From Baseline in Average Daily Severity Score of Gastroesophageal Reflux Disease (GERD)-Related Symptoms at Week 4 [ Time Frame: Baseline and Week 4 ]Participants collected GERD-associated symptoms of daytime heartburn, nighttime heartburn and regurgitation in daily symptom diary. Daytime episodes were defined as those that occurred after arising in the morning until retiring in the evening, and nighttime episodes were defined as those that occurred during the night while sleeping or trying to sleep. The severity score was calculated was based on a 5-point Likert scale ranging from 0 (no symptom) to 4 (very severe symptom); higher scores indicated greater disease activity.
- Percentage of Participants With Complete Heartburn Relief [ Time Frame: Week 2 and Week 4 ]Participants completed a daily symptom diary.
- Time to Achieve First 24-Hour Period Without Heartburn [ Time Frame: Baseline to Week 4 ]Participants completed a daily symptom diary.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00911534
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|Study Director:||Guillermo Rossiter, MD||Eisai Inc.|