A Study of Dexlansoprazole Modified Release Formulation to Treat Night Heartburn
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|ClinicalTrials.gov Identifier: NCT00627016|
Recruitment Status : Completed
First Posted : February 29, 2008
Results First Posted : May 6, 2010
Last Update Posted : April 28, 2011
|Condition or disease||Intervention/treatment||Phase|
|Gastroesophageal Reflux||Drug: Dexlansoprazole Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||305 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||A Phase 3 Multicenter, Randomized, Double-Blind, Parallel Group, Placebo Controlled Trial to Evaluate the Efficacy of TAK-390MR (30 mg QD) Compared to Placebo on Relief of Nocturnal Heartburn in Subjects With Symptomatic Gastroesophageal Reflux Disease (GERD)|
|Study Start Date :||March 2008|
|Primary Completion Date :||March 2009|
|Study Completion Date :||March 2009|
|Experimental: Dexlansoprazole 30 mg QD||
30 mg capsule, orally, once daily for 4 weeks
|Placebo Comparator: Placebo||
1 capsule, orally, once daily for 4 weeks
- Median Percentage of Nights Without Heartburn Over 4 Weeks as Assessed by Daily Diary. [ Time Frame: 4 Weeks ]Percentage calculated by the number of heartburn-free nights out of the total number of nights during the treatment period with a diary entry indicating presence or absence of nighttime heartburn in subjects who had ≥1 diary entry indicating presence or absence of nighttime heartburn, as indicated by the subject's daily diary. Subjects indicate the presence (Yes/No) of nocturnal heartburn symptoms in a Daily Electronic Diary. Nights missing diary results were excluded from the numerator and denominator.
- Percent of Subjects With Relief of Night Time Heartburn Over the Last 7 Days of Treatment as Assessed by Daily Diary. [ Time Frame: Last 7 days of treatment ]Relief of nighttime heartburn was defined as 6 of 7 nights with no heartburn and at most 1 night with mild heartburn; lack of relief of nighttime heartburn was defined as 2 or more out of 7 nights with heartburn, or 1 night with at least moderate heartburn. Subjects indicate the presence and severity (mild, moderate, severe, or very severe) of nocturnal heartburn in a Daily Electronic Diary. The percentage was calculated as the number of subjects with relief of nighttime heartburn divided by the number of subjects whose relief status could be determined.
- Percentage of Participants With Relief of Gastro-Esophageal Reflux Disease (GERD) Associated Sleep Disturbances Over the Last 7 Days of Treatment as Assessed by Daily Diary. [ Time Frame: Last 7 days of treatment ]Relief of GERD-associated sleep disturbance was defined as 6 of 7 nights with no GERD associated sleep disturbances; lack of relief of GERD-associated sleep disturbance was defined as 2 or more out of 7 nights with GERD-associated sleep disturbance. Subjects indicate the presence (Yes/No) of GERD associated sleep disturbance in a Daily Electronic Diary. The percentage was calculated as the number of subjects with relief of GERD-associated sleep disturbance divided by the number of subjects whose relief status could be determined.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00627016
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|Study Chair:||Medical Director||Takeda|