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

July 20, 2010 updated by: Takeda

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

162

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Bialystok, Poland
      • Cracow, Poland
      • Katowice, Poland
      • Lodz, Poland
      • Lublin, Poland
      • Rzeszow, Poland
      • Warsawa, Poland
      • Wroclaw, Poland
  • United States
    • Florida
      • Tampa, Florida, United States
    • Illinois
      • Park Ridge, Illinois, United States
    • Louisiana
      • Shreveport, Louisiana, United States
    • Michigan
      • Flint, Michigan, United States
    • Nebraska
      • Omaha, Nebraska, United States
    • New York
      • Buffalo, New York, United States
    • Ohio
      • Cincinnati, Ohio, United States
      • Youngstown, Ohio, United States
    • Virginia
      • Vienna, Virginia, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 11 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo QD
Drug: Placebo
Lansoprazole placebo-matching suspension, orally, once daily for up to 28 days.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Week 4
Safety Assessments
Time Frame: Baseline through week 8
Baseline through week 8

Secondary Outcome Measures

Outcome Measure
Time Frame
Global Symptom Assessment, as answered by Investigator and Parent/Guardian
Time Frame: Baseline through Week 8
Baseline through Week 8
Sensitivity analyses of the primary endpoint
Time Frame: Week 4
Week 4
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.
At the end of the double-blind treatment period and 30 days after the last dose of study drug.
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.
During and at the end of the Double-blind treatment period and 30 days after the last dose of study drug.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Takeda

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (Actual)

May 1, 2007

Study Completion (Actual)

May 1, 2007

Study Registration Dates

First Submitted

May 9, 2006

First Submitted That Met QC Criteria

May 9, 2006

First Posted (Estimate)

May 11, 2006

Study Record Updates

Last Update Posted (Estimate)

July 22, 2010

Last Update Submitted That Met QC Criteria

July 20, 2010

Last Verified

July 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P-GI05-109
  • 2006-000957-23 (EudraCT Number)
  • U1111-1114-2358 (Registry Identifier: WHO)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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