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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: | NCT00324974 |
This study will assess the safety and efficacy of once daily administration of Lansoprazole Microgranules Oral Suspension in infants with gastroesophageal reflux symptoms during a 4-week treatment period.
Condition | Intervention | Phase |
---|---|---|
Gastroesophageal Reflux Disease |
Drug: Lansoprazole Microgranules suspension Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase 3, Randomized, Multi-Center, Double-Blind, Placebo-Controlled, Parallel Group Study Assessing the Safety and Efficacy of Lansoprazole Microgranules Oral Suspension in Infants With Symptomatic Gastroesophageal Reflux |
Enrollment: | 162 |
Study Start Date: | June 2006 |
Study Completion Date: | May 2007 |
Primary Completion Date: | May 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: Lansoprazole Microgranules suspension
Lansoprazole microgranules 0.2-0.3 mg/kg/day suspension, orally, once daily for up to 28 days for infants less than 10 weeks; Lansoprazole microgranules 1.0-1.5 mg/kg/day suspension, orally, once daily for up to 28 days for infants greater than 10 weeks. |
2: Placebo Comparator |
Drug: Placebo
Lansoprazole placebo-matching suspension, orally, once daily for up to 28 days.
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This study will be conducted by approximately 20 investigative sites in the U.S. and Poland. Subjects who qualify will be randomized in equal proportions to receive either lansoprazole Pediatric Suspension (0.2-0.3 mg/kg/day in infants <10 weeks of age or 1.0-1.5 mg/kg/day in infants >10 weeks of age) or Placebo. This study consists of three periods: Pretreatment Period of 7-14 days, Double-Blind Treatment Period of 4 weeks (Dosing), and the Post-Treatment Period of 30 days (Follow-Up).
Ages Eligible for Study: | 1 Month to 11 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Florida | |
Tampa, Florida, United States | |
United States, Illinois | |
Park Ridge, Illinois, United States | |
United States, Louisiana | |
Shreveport, Louisiana, United States | |
United States, Michigan | |
Flint, Michigan, United States | |
United States, Nebraska | |
Omaha, Nebraska, United States | |
United States, New York | |
Buffalo, New York, United States | |
United States, Ohio | |
Cincinnati, Ohio, United States | |
Youngstown, Ohio, United States | |
United States, Virginia | |
Vienna, Virginia, United States | |
Poland | |
Bialystok, Poland | |
Cracow, Poland | |
Katowice, Poland | |
Lodz, Poland | |
Wroclaw, Poland | |
Rzeszow, Poland | |
Warsawa, Poland | |
Lublin, Poland |
Study Director: | Medical Director | Takeda Global Research & Development Center, Inc. |
Responsible Party: | Takeda Global Research & Development Center, Inc. ( Sr. VP Clinical Sciences ) |
Study ID Numbers: | P-GI05-109, EudraCT# 2006-000957-23 |
Study First Received: | May 9, 2006 |
Last Updated: | January 13, 2009 |
ClinicalTrials.gov Identifier: | NCT00324974 |
Health Authority: | United States: Food and Drug Administration; Poland: Ministry of Health |
Gastroesophageal Reflux Disease infant lansoprazole oral suspension PPI |
Deglutition Disorders Esophageal Motility Disorders Digestive System Diseases Esophageal disorder |
Gastrointestinal Diseases Lansoprazole Esophageal Diseases Gastroesophageal Reflux |
Anti-Infective Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses Anti-Ulcer Agents |
Gastrointestinal Agents Enzyme Inhibitors Pharmacologic Actions |