The Use of Lansoprazole to Treat Infants With Symptoms of Gastroesophageal Reflux
This study has been completed.
Sponsor:
Takeda Global Research & Development Center, Inc.
Information provided by:
Takeda Global Research & Development Center, Inc.
ClinicalTrials.gov Identifier:
NCT00324974
First received: May 9, 2006
Last updated: July 20, 2010
Last verified: July 2010
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this study is to assess the safety and efficacy of lansoprazole microgranules oral suspension, once daily (QD), 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 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Takeda Global Research & Development Center, Inc.:
Primary Outcome Measures:
- Percentage of subjects in each treatment group responding to treatment with a reduction from baseline in the percentage and duration of crying/fussing/irritability episodes associated with feeding after 4 weeks of treatment. [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
- Safety Assessments [ Time Frame: Baseline through week 8 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Global Symptom Assessment, as answered by Investigator and Parent/Guardian [ Time Frame: Baseline through Week 8 ] [ Designated as safety issue: No ]
- Sensitivity analyses of the primary endpoint [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
- Additional Daily Diary-based symptom Assessments [ Time Frame: At the end of the double-blind treatment period and 30 days after the last dose of study drug. ] [ Designated as safety issue: No ]
- Indicators of Growth Parameters [ Time Frame: During and at the end of the Double-blind treatment period and 30 days after the last dose of study drug. ] [ Designated as safety issue: No ]
| 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 |
|---|---|
| Experimental: Lansoprazole QD |
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. |
| Placebo Comparator: Placebo QD |
Drug: Placebo
Lansoprazole placebo-matching suspension, orally, once daily for up to 28 days.
|
Detailed Description:
This study will be conducted by approximately 20 investigative sites in the U.S. and Poland. Participants 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).
Eligibility| Ages Eligible for Study: | 1 Month to 11 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- At least 7 days post-surgery at the time of Screening (Study Visit 1) with no anticipated need for surgery during the study.
- Experiencing symptoms of gastroesophageal reflux disease (regurgitation, vomiting or "spitting up," fussing/irritability, feeding refusal, crying during feeding, arching back, poor weight gain, or extraesophageal manifestations) or endoscopy proven reflux disease.
- Must continue to have reflux symptoms during the Pretreatment Period despite reducing or eliminating exposure to tobacco smoke, using one positioning and feeding strategy the last 7 days as documented in the Daily Diary.
- The infant exhibited crying, fussing, or irritability during or within 1 hour of feeding in >25% of all feedings during the last 4 days of the Pretreatment Period as documented in the Daily Diary.
Exclusion Criteria:
- Body weight <2.0 kilogram at Dosing Day 1 of the Double-Blind Treatment Period.
- Unstable, congenital or acquired, clinically significant disease of any major organ system (cardiovascular, respiratory, renal, hepatic, metabolic, etc.), including suspected and/or documented culture-proven sepsis.
- Coexisting esophageal disease (e.g., eosinophilic esophagitis, viral, bacterial or fungal infection) or caustic or physiochemical trauma to the esophagus.
- Any congenital anomaly of the upper gastric intestinal tract that might interfere with gastrointestinal motility, pH, absorption, or active or known history of necrotizing enterocolitis that has been surgically corrected.
- Use of a proton pump inhibitor within 30 days prior to Dosing Day 1.
- Use of H2 Blockers (i.e. Zantac) within 7 days prior to Dosing Day 1.
- Allergy to proton pump inhibitors (i.e. Prilosec, Prevacid).
- Use of prokinetics (e.g., metoclopramide) unless on a stable dose for at least 3 days prior to entering the Pretreatment Period.
- Unable to obtain stable drug levels after continuous treatment with required drugs including theophylline derivatives, digoxin, phenytoin, phenobarbital, or carbamazepine within the 7 days prior to Dosing Day 1.
- Clinically Significant abnormalities in clinical laboratory values.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00324974
Locations
| 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 | |
| Lublin, Poland | |
| Rzeszow, Poland | |
| Warsawa, Poland | |
| Wroclaw, Poland | |
Sponsors and Collaborators
Takeda Global Research & Development Center, Inc.
Investigators
| Study Director: | Medical Director | Takeda Global Research & Development Center, Inc. |
More Information
Additional Information:
Publications:
| Responsible Party: | Sr. VP Clinical Sciences, Takeda Global Research & Development Center, Inc. |
| ClinicalTrials.gov Identifier: | NCT00324974 History of Changes |
| Other Study ID Numbers: | P-GI05-109, 2006-000957-23, U1111-1114-2358 |
| Study First Received: | May 9, 2006 |
| Last Updated: | July 20, 2010 |
| Health Authority: | United States: Food and Drug Administration Poland: Ministry of Health |
Keywords provided by Takeda Global Research & Development Center, Inc.:
|
Gastroesophageal Reflux Disease infant lansoprazole oral suspension PPI |
Additional relevant MeSH terms:
|
Gastroesophageal Reflux Esophageal Motility Disorders Deglutition Disorders Esophageal Diseases Gastrointestinal Diseases Digestive System Diseases Lansoprazole |
Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Anti-Ulcer Agents Gastrointestinal Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013