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The Use of Lansoprazole to Treat Infants With Symptoms of Gastroesophageal Reflux

This study has been completed.
Sponsor:
Information provided by:
Takeda
ClinicalTrials.gov Identifier:
NCT00324974
First received: May 9, 2006
Last updated: July 20, 2010
Last verified: July 2010
  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:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
Study Director: Medical Director Takeda
  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:
Gastroesophageal Reflux Disease
infant
lansoprazole oral suspension
PPI

Additional relevant MeSH terms:
Gastroesophageal Reflux
Deglutition Disorders
Digestive System Diseases
Esophageal Diseases
Esophageal Motility Disorders
Gastrointestinal Diseases
Dexlansoprazole
Lansoprazole
Anti-Ulcer Agents
Enzyme Inhibitors
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Proton Pump Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014