NCT00324974

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
162

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jun 2006

Shorter than P25 for phase_3

Geographic Reach
2 countries

17 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 9, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 11, 2006

Completed
21 days until next milestone

Study Start

First participant enrolled

June 1, 2006

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

July 22, 2010

Status Verified

July 1, 2010

Enrollment Period

11 months

First QC Date

May 9, 2006

Last Update Submit

July 20, 2010

Conditions

Gastroesophageal Reflux Disease

Keywords

Gastroesophageal Reflux Diseaseinfantlansoprazole oral suspensionPPI

Outcome Measures

Primary Outcomes (2)

  • 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.

    Week 4

  • Safety Assessments

    Baseline through week 8

Secondary Outcomes (4)

  • Global Symptom Assessment, as answered by Investigator and Parent/Guardian

    Baseline through Week 8

  • Sensitivity analyses of the primary endpoint

    Week 4

  • Additional Daily Diary-based symptom Assessments

    At the end of the double-blind treatment period and 30 days after the last dose of study drug.

  • Indicators of Growth Parameters

    During and at the end of the Double-blind treatment period and 30 days after the last dose of study drug.

Study Arms (2)

Lansoprazole QD

EXPERIMENTAL
Drug: Lansoprazole microgranules suspension

Placebo QD

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Lansoprazole microgranules suspensionDRUG

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.

Lansoprazole QD
PlaceboDRUG

Lansoprazole placebo-matching suspension, orally, once daily for up to 28 days.

Placebo QD

Eligibility Criteria

Age1 Month - 11 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Unknown Facility

Tampa, Florida, United States

Location

Unknown Facility

Park Ridge, Illinois, United States

Location

Unknown Facility

Shreveport, Louisiana, United States

Location

Unknown Facility

Flint, Michigan, United States

Location

Unknown Facility

Omaha, Nebraska, United States

Location

Unknown Facility

Buffalo, New York, United States

Location

Unknown Facility

Cincinnati, Ohio, United States

Location

Unknown Facility

Youngstown, Ohio, United States

Location

Unknown Facility

Vienna, Virginia, United States

Location

Unknown Facility

Bialystok, Poland

Location

Unknown Facility

Katowice, Poland

Location

Unknown Facility

Krakow, Poland

Location

Unknown Facility

Lodz, Poland

Location

Unknown Facility

Lublin, Poland

Location

Unknown Facility

Rzeszów, Poland

Location

Unknown Facility

Warsaw, Poland

Location

Unknown Facility

Wroclaw, Poland

Location

Related Publications (1)

  • Orenstein SR, Hassall E, Furmaga-Jablonska W, Atkinson S, Raanan M. Multicenter, double-blind, randomized, placebo-controlled trial assessing the efficacy and safety of proton pump inhibitor lansoprazole in infants with symptoms of gastroesophageal reflux disease. J Pediatr. 2009 Apr;154(4):514-520.e4. doi: 10.1016/j.jpeds.2008.09.054. Epub 2008 Dec 3.

    PMID: 19054529RESULT

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Medical Director

    Takeda

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 9, 2006

First Posted

May 11, 2006

Study Start

June 1, 2006

Primary Completion

May 1, 2007

Study Completion

May 1, 2007

Last Updated

July 22, 2010

Record last verified: 2010-07

Locations

PL(8)US(9)