Safety and Efficacy of Dexlansoprazole Delayed-Release Capsules in Treating Symptomatic Non-Erosive Gastroesophageal Reflux Disease in Adolescents
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|ClinicalTrials.gov Identifier: NCT01642602|
Recruitment Status : Completed
First Posted : July 17, 2012
Results First Posted : August 6, 2014
Last Update Posted : August 6, 2014
|Condition or disease||Intervention/treatment||Phase|
|Gastroesophageal Reflux Disease||Drug: Dexlansoprazole||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||104 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Open-Label, Multicenter, 4-Week Study to Assess the Safety and Effectiveness of Daily Oral Administration of Dexlansoprazole Delayed-Release Capsules for Relief of Heartburn, in Adolescent Subjects Aged 12 to 17 Years With Symptomatic Non-Erosive Gastroesophageal Reflux Disease|
|Study Start Date :||July 2012|
|Actual Primary Completion Date :||January 2014|
|Actual Study Completion Date :||January 2014|
Experimental: Dexlansoprazole 30 mg
Dexlansoprazole 30 mg delayed-release capsules orally once daily for up to 4 weeks.
Dexlansoprazole delayed-release capsules.
- Percent of Participants Who Experience Each Treatment Emergent Adverse Event Experienced by ≥5% of Participants While Receiving Dexlansoprazole During the 4 Week Treatment Period [ Time Frame: 4 weeks ]A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that started or worsened on or after Study Day 1 (defined as first dose day), and no more than 30 days after the last dose of study drug.
- The Percentage of Days With Neither Daytime Nor Nighttime Heartburn Over the 4 Weeks of Treatment [ Time Frame: 4 weeks ]Participants documented the presence or absence and the degree to which daytime and nighttime heartburn symptoms hurt daily in an electronic daily 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): NCT01642602
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|Study Director:||Medical Director Clinical Science||Takeda Global Research and Development Center, Inc.|