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

NCT ID: NCT00220818

Last Updated: 2010-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-01-31
• Study Completion Date: 2005-07-31

Brief Summary

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.

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.

Conditions

Gastroesophageal Reflux Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lansoprazole 1.0 mg/kg QD

Group Type: EXPERIMENTAL

Lansoprazole

Intervention Type: DRUG

Lansoprazole 1.0 mg/kg/day suspension, orally, once daily for up to 5 days.

Lansoprazole 2.0 mg/kg QD

Group Type: EXPERIMENTAL

Lansoprazole

Intervention Type: DRUG

Lansoprazole 2.0 mg/kg/day suspension, orally, once daily for up to 5 days.

Interventions

Lansoprazole

Lansoprazole 1.0 mg/kg/day suspension, orally, once daily for up to 5 days.

Intervention Type: DRUG

Lansoprazole

Lansoprazole 2.0 mg/kg/day suspension, orally, once daily for up to 5 days.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 29 Days
• Maximum Eligible Age: 364 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Takeda

INDUSTRY

Sponsor Role: lead

Responsible Party

Takeda Global Research & Development Center, Inc.

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Takeda

References

Springer M, Atkinson S, North J, Raanan M. Safety and pharmacodynamics of lansoprazole in patients with gastroesophageal reflux disease aged <1 year. Paediatr Drugs. 2008;10(4):255-63. doi: 10.2165/00148581-200810040-00004.

Reference Type: RESULT

PMID: 18590344 (View on PubMed)

Zhang W, Kukulka M, Witt G, Sutkowski-Markmann D, North J, Atkinson S. Age-dependent pharmacokinetics of lansoprazole in neonates and infants. Paediatr Drugs. 2008;10(4):265-74. doi: 10.2165/00148581-200810040-00005.

Reference Type: RESULT

PMID: 18590345 (View on PubMed)

Other Identifiers

U1111-1114-0294

Identifier Type: REGISTRY

Identifier Source: secondary_id

C03-043

Identifier Type: -

Identifier Source: org_study_id