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Sponsored by: |
Takeda Global Research & Development Center, Inc. |
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Information provided by: | Takeda Global Research & Development Center, Inc. |
ClinicalTrials.gov Identifier: | NCT00847210 |
The purpose of this study is to asses the pharmacokinetics and safety of dexlansoprazole in adolescent subjects.
Condition | Intervention | Phase |
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Gastroesophageal Reflux |
Drug: Dexlansoprazole MR |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Pharmacokinetics Study |
Official Title: | A Phase 1, Randomized, Open-Label, Parallel Group, Multicenter Study to Evaluate the Pharmacokinetics and Safety of Dexlansoprazole Modified Release Capsules (30 mg and 60 mg) in Adolescents With Symptomatic Gastroesophageal Reflux Disease |
Estimated Enrollment: | 36 |
Study Start Date: | March 2009 |
Estimated Study Completion Date: | September 2009 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: Dexlansoprazole MR
Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 7 days.
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2: Experimental |
Drug: Dexlansoprazole MR
Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 7 days.
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Gastroesophageal reflux disease is a condition of multifactorial etiology resulting in the reflux of gastric contents into the esophagus through the lower esophageal sphincter. The prevalence of Gastroesophageal reflux disease in the pediatric population is becoming increasingly recognized and documented. It is a chronic disease that can persist through adulthood with symptoms in older children and adolescents being similar to those seen in adults. The prevalence of gastroesophageal reflux disease increases with age, from 2.5% of children between the ages of 3 and 9 years, to 8.5% of those between the ages of 10 and 17 years.
Younger children generally present with extra-esophageal manifestations, regurgitation, and epigastric pain, while older children and adolescents typically present with adult-type gastroesophageal reflux disease symptoms of heartburn and regurgitation. Treatment for gastroesophageal reflux disease is aimed at alleviating symptoms and healing the esophageal inflammation.
This study will evaluate the safety of dexlansoprazole MR in the pediatric population (ages 12-17) and to determine if the pharmacokinetic profile is similar to that in adults given the same dose.
Ages Eligible for Study: | 12 Years to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Takeda Study Registration Call Center | 800-778-2860 | medicalinformation@tpna.com |
Study Director: | Medical Director Pharmacovigilance | Takeda Global Research & Development Center, Inc. |
Responsible Party: | Takeda Global Research & Development Center, Inc. ( Sr. VP, Clinical Science ) |
Study ID Numbers: | T-P107-163 |
Study First Received: | February 18, 2009 |
Last Updated: | February 19, 2009 |
ClinicalTrials.gov Identifier: | NCT00847210 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Esophageal Reflux Gastro-Esophageal Reflux Gastroesophageal Reflux Disease GERD |
Regurgitation, Gastric Heartburn Drug Therapy Adolescent |
Deglutition Disorders Esophageal Motility Disorders Pyrosis Digestive System Diseases Esophageal Disorder |
Gastrointestinal Diseases Heartburn Lansoprazole Esophageal Diseases Gastroesophageal Reflux |
Anti-Infective Agents Molecular Mechanisms of Pharmacological Action Gastrointestinal Diseases Gastrointestinal Agents Enzyme Inhibitors Gastroesophageal Reflux Pharmacologic Actions |
Esophageal Motility Disorders Deglutition Disorders Digestive System Diseases Therapeutic Uses Anti-Ulcer Agents Esophageal Diseases Lansoprazole |