EUCTR2012-001681-15-ITActive, not recruitingPhase 1
A Phase 2 Multicenter, 36-Week Study to Assess the Safety andEffectiveness of Daily Oral Administration of Dexlansoprazole Delayed-Release Capsules for Healing of Erosive Esophagitis and Maintenance ofHealed Erosive Esophagitis and Relief of Heartburn, in Adolescent SubjectsAged 12 to 17 Years
TAKEDA EUROPE RESEARCH & DEVELOPMENT CENTRE LTD0 sites62 target enrollmentStarted: October 17, 2012Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 62
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •The subjects must be aged between 12 and 17 years, with a history of symptoms of gastroesophageal reflux disease (GERD) at least 3 months before screening, according to the investigator assessments. To be enrolled in the study, the subject must have heartburn for at least 3 days out of 7 during the screening as logging on daily electronic diary and endoscopically proven EE.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 60
- •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
Exclusion Criteria
- •Subjects with an unusual or allergic reaction to dexlansoprazolo or any component of dexlansoprazolo, any of the other proton pump inhibitors (including lansoprazole, omeprazole, rabeprazole, esomeprazole, or pantoprazole), or with antacids containing magnesium hydroxide and / or hydroxide aluminum or simethicone. Individuals with evidence of cardiovascular disease, pulmonary, central nervous system, liver, hematopoietic, renal, metabolic, endocrine or gastrointestinal, or severe allergies, asthma or allergic skin rash that suggests the underlying disease or condition and uncontrolled clinically significant (different from the disease in study), which may affect the subject's ability to participate or could potentially confound the results of the study or any clinically significant discovery resulting from physical examinations and clinical laboratory results, in the opinion of the investigator. Those who need to take prescription drugs or over the counter, which are listed under Drugs & treatments except the Protocol (Section 7.3).
Investigators
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