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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: | NCT00174928 |
The study is being conducted to understand how quickly the study drug works to improve feeding and to study the safety of the drug in premature babies or babies less than 28 days of age.
Condition | Intervention | Phase |
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Gastroesophageal Reflux Disease |
Drug: Lansoprazole |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Pharmacokinetics/Dynamics Study |
Official Title: | A Phase 1, Single- and Repeated-Dose, Randomized, Open-Label, Multi-Center Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety of Lansoprazole in Neonates With Clinically-Evident Gastroesophageal Reflux Disease. |
Enrollment: | 24 |
Study Start Date: | May 2005 |
Study Completion Date: | August 2005 |
Primary Completion Date: | August 2005 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: Lansoprazole
Lansoprazole 0.5 mg/kg/day suspension, orally, once daily for up to 5 Days.
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2: Experimental |
Drug: Lansoprazole
Lansoprazole 1.0 mg/kg/day suspension, orally, once daily for up to 5 Days.
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A Phase 1, multi-center, pharmacokinetic/pharmacodynamic and safety, study in which neonates will be randomized in an open-label fashion to receive 5 days of open-label treatment with either lansoprazole pediatric suspension 1.0 mg/kg/day orally or lansoprazole pediatric suspension .5 mg/kg/day orally. On dosing Days 1 and 5, blood samples will be obtained for drug assay. All subjects will be evaluated for inclusion in the pH monitoring portion of the study and will undergo pH monitoring, provided it is clinically indicated, at the discretion of the investigator. Intragastric pH monitoring (up to 24 hours) will be performed at baseline, on dosing Day 1 (or Day 2) and on dosing Day 5 (or Day 6). Intraesophageal pH may be done in addition to intragastric pH at the discretion of the investigator. Subjects will be evaluated for safety, including a follow-up visit on post-dosing Day 14.
Ages Eligible for Study: | up to 28 Days |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Takeda Global Research & Development Center, Inc. ( Sr. VP Clinical Sciences ) |
Study ID Numbers: | C03-042 |
Study First Received: | September 9, 2005 |
Last Updated: | December 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00174928 History of Changes |
Health Authority: | United States: Food and Drug Administration; Poland: Ministry of Health |
Pediatric GERD Pediatric Gastroesophageal Reflux Disease Neonates lansoprazole |
Deglutition Disorders Esophageal Motility Disorders Anti-Infective Agents Digestive System Diseases Esophageal Disorder |
Gastrointestinal Diseases 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 |