A Phase 2 Open-Label, Multicenter, 4-Week Study to Assess the safety andEffectiveness of Daily Oral Administration of Dexlansoprazole Delayed-Release Capsules for Relief of Heartburn, in Adolescent subjects Aged 12 to17 Years With Symptomatic Non-Erosive Gastroesophageal Reflux Disease
- Conditions
- Heartburn in Adolescent subjects With Symptomatic Non-Erosive Gastroesophageal Reflux DiseaseMedDRA version: 14.1Level: LLTClassification code 10018203Term: GERDSystem Organ Class: 100000004856MedDRA version: 14.1Level: LLTClassification code 10042079Term: Stomach burning sensation ofSystem Organ Class: 100000004856Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2012-001680-72-IT
- Lead Sponsor
- TAKEDA EUROPE RESEARCH & DEVELOPMENT CENTRE LTD
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 104
The subjects must be aged between 12 and 17 years (inclusive) and have a history of symptoms of gastroesophageal reflux disease (GERD) at least 3 months prior to screening, based on assessments of the investigator. To be enrolled in the study, patients must have heartburn for at least 3 days out of 7 during the screening period, bringing in the daily electronic diary.
Are the trial subjects under 18? yes
Number of subjects for this age range: 100
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
patients with erosive esophagitis. Subjects with a history of hypersensitivity or allergic to dexlansoprazolo, any of its components, antacids or any proton pump inhibitor (PPI) (including lansoprazole, omeprazole, rabeprazole, pantoprazole and esomeprazole). Subjects who show evidence of cardiovascular, pulmonary, central nervous system, liver, hematopoietic, renal, metabolic, endocrine or gastrointestinal, or with severe allergies, asthma or skin rashes suggestive of allergic origin of diseases or conditions are not controlled and significant (different from the disease under study) that could interfere with the ability to participate in the subject or potentially confuse the results of the study, or clinically important findings arising from the results of physical examination or laboratory analysis, in the opinion of the investigator. Persons who must take prescription drugs or over the counter drugs and treatments listed in the section except the protocol (Section 7.3).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Timepoint(s) of evaluation of this end point: An electronic daily diary is maintained and a full examination and evaluation of end points takes place during week 4 of treatment at the final visit;Main Objective: To assess the safety and effectiveness of treatment with once daily oral administration of dexlansoprazole delayed-release capsules (30 mg) in adolescent subjects aged 12 to 17 years, with symptomatic non-erosive GERD.;Secondary Objective: NA;Primary end point(s): Treatment-emergent adverse events (TEAE) experienced by =5% of subjects while receiving dexlansoprazole during the 4 week Treatment Period.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): The percentage of days with neither daytime nor nighttime heartburn over the 4 weeks of treatment as assessed by electronic daily diary.;Timepoint(s) of evaluation of this end point: An electronic daily diary is maintained and a full examination and evaluation of end points takes place during week 4 of treatment at the final visit