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

This study has been completed.
Information provided by:
ClinicalTrials.gov Identifier:
First received: September 9, 2005
Last updated: July 20, 2010
Last verified: July 2010
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.

Condition Intervention Phase
Gastroesophageal Reflux Disease
Drug: Lansoprazole
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1, Single- and Repeated-Dose, Randomized, Open-Label, Multi-center Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety of Lansoprazole in Neonates With Clinically-Evident Gastroesophageal Reflux Disease.

Resource links provided by NLM:

Further study details as provided by Takeda:

Primary Outcome Measures:
  • Pharmacokinetic Analysis [ Time Frame: Day 1 and 5 ] [ Designated as safety issue: No ]
  • Mean Intragastric 24 hour pH (subset of six subjects) [ Time Frame: Day -1, Day 1 and Day 5 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Gastroesophageal Reflux Disease Symptom Analysis [ Time Frame: Days 1-5 ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: May 2005
Study Completion Date: August 2005
Primary Completion Date: August 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lansoprazole 0.5 mg/kg QD Drug: Lansoprazole
Lansoprazole 0.5 mg/kg/day suspension, orally, once daily for up to 5 days.
Experimental: Lansoprazole 1.0 mg/kg QD Drug: Lansoprazole
Lansoprazole 1.0 mg/kg/day suspension, orally, once daily for up to 5 days.

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.

Ages Eligible for Study:   up to 28 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00174928

Sponsors and Collaborators
Study Director: Medical Director Takeda
  More Information

Additional Information:
Responsible Party: Sr. VP Clinical Sciences, Takeda Global Research & Development Center, Inc.
ClinicalTrials.gov Identifier: NCT00174928     History of Changes
Other Study ID Numbers: C03-042  U1111-1113-9957 
Study First Received: September 9, 2005
Last Updated: July 20, 2010
Health Authority: United States: Food and Drug Administration
Poland: Ministry of Health

Keywords provided by Takeda:
Pediatric GERD
Pediatric Gastroesophageal Reflux Disease

Additional relevant MeSH terms:
Gastroesophageal Reflux
Deglutition Disorders
Digestive System Diseases
Esophageal Diseases
Esophageal Motility Disorders
Gastrointestinal Diseases
Anti-Ulcer Agents
Enzyme Inhibitors
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Proton Pump Inhibitors

ClinicalTrials.gov processed this record on May 26, 2016