A Study to Evaluate the Effect of Lansoprazole on Hospitalized Neonates With Gastroesophageal Reflux Disease

NCT ID: NCT00174928

Last Updated: 2010-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-05-31
• Study Completion Date: 2005-08-31

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, multi-center, pharmacokinetic/pharmacodynamic and safety, study in which neonates will be randomized in an open-label fashion to receive 5 days of open-label treatment with either lansoprazole pediatric suspension 1.0 mg/kg/day orally or lansoprazole pediatric suspension .5 mg/kg/day orally. 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 0.5 mg/kg QD

Group Type: EXPERIMENTAL

Lansoprazole

Intervention Type: DRUG

Lansoprazole 0.5 mg/kg/day suspension, orally, once daily for up to 5 days.

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.

Interventions

Lansoprazole

Lansoprazole 0.5 mg/kg/day suspension, orally, once daily for up to 5 days.

Intervention Type: DRUG

Lansoprazole

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Neonates in the Neonatal Intensive Care or Special Care Nursery who have been fed orally or by feeding tube.
• Term or post-term infants with a body weight of >800 gms.
• Pre-term infants with a corrected age of less than 44 weeks.
• Clinically-evident GERD (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: 1 Day
• Maximum Eligible Age: 28 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

U1111-1113-9957

Identifier Type: REGISTRY

Identifier Source: secondary_id

C03-042

Identifier Type: -

Identifier Source: org_study_id