A Study to Evaluate the Effect of Lansoprazole on Infants With Gastroesophageal Reflux Disease.

July 20, 2010 updated by: Takeda

A Phase 1, Single- and Repeated-Dose, Randomized, Open-Label, Multicenter Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety of Lansoprazole in Infants With Clinically-Evident Gastroesophageal Reflux Disease.

The purpose of this study is to understand how quickly lansoprazole, once daily (QD), improves feeding in premature babies or babies less than 28 days of age.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A Phase 1, multicenter, pharmacokinetic/Pharmacodynamic and safety study in which infants will be randomized in an open-label fashion to receive 5 days of open-label treatment with lansoprazole pediatric suspension 1 mg/kg/day oral, or lansoprazole pediatric suspension 2 mg/kg/day oral. On Dosing Days 1 and 5, blood samples will be obtained for drug assay. All subjects will be evaluated for inclusion in the pH monitoring portion of the study and will undergo pH monitoring, provided it is clinically indicated, at the discretion of the investigator. Intragastric pH monitoring (up to 24 hours) will be performed at Baseline, on Dosing Day 1 (or Day 2) and on Dosing Day 5 (or Day 6). Intraesophageal pH may be done in addition to intragastric pH at the discretion of the investigator. Subjects will be evaluated for safety, including a follow-up visit on Post-Dosing Day 14.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

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

4 weeks to 11 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Hospitalized or outpatient male or female, term or post-term infants beyond the neonatal period (>28 days) but less than 12 months of age, OR a preterm infant with a corrected age of at least 44 weeks but less than 12 months on Dosing Day 1.
  • Clinically-evident Gastroesophageal Reflux Disease (feeding intolerance, regurgitation, wheezing or stridor with feedings)
  • At least 7 days post-surgery without anticipated need for surgery during study
  • No significant laboratory abnormalities

Exclusion Criteria:

  • Unstable, clinically significant disease or abnormality
  • Congenital anomaly of the upper gastrointestinal tract
  • Clinical evidence of acute sepsis
  • Cystic fibrosis
  • Medical condition requiring subject to not be fed by mouth/gastric tube

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lansoprazole 1.0 mg/kg QD
Drug: Lansoprazole
Lansoprazole 1.0 mg/kg/day suspension, orally, once daily for up to 5 days.
Drug: Lansoprazole
Lansoprazole 2.0 mg/kg/day suspension, orally, once daily for up to 5 days.
Experimental: Lansoprazole 2.0 mg/kg QD
Drug: Lansoprazole
Lansoprazole 1.0 mg/kg/day suspension, orally, once daily for up to 5 days.
Drug: Lansoprazole
Lansoprazole 2.0 mg/kg/day suspension, orally, once daily for up to 5 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetic Analysis.
Time Frame: Day 1 and 5
Day 1 and 5
Mean Intragastric 24 hour pH (subset of 6 subjects)
Time Frame: Day -1, 1 and 5
Day -1, 1 and 5

Secondary Outcome Measures

Outcome Measure
Time Frame
Gastroesophageal Reflux Disease Symptom Assessment.
Time Frame: Days 1-5
Days 1-5

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

January 1, 2005

Primary Completion (Actual)

July 1, 2005

Study Completion (Actual)

July 1, 2005

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

September 19, 2005

First Posted (Estimate)

September 22, 2005

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

  • C03-043
  • U1111-1114-0294 (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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