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

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ClinicalTrials.gov Identifier: NCT00174928
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : July 22, 2010
Sponsor:
Information provided by:
Takeda

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.

Condition or disease Intervention/treatment Phase
Gastroesophageal Reflux Disease Drug: Lansoprazole Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Study Start Date : May 2005
Primary Completion Date : August 2005
Study Completion Date : August 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD
U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Pharmacokinetic Analysis [ Time Frame: Day 1 and 5 ]
  2. Mean Intragastric 24 hour pH (subset of six subjects) [ Time Frame: Day -1, Day 1 and Day 5 ]

Secondary Outcome Measures :
  1. Gastroesophageal Reflux Disease Symptom Analysis [ Time Frame: Days 1-5 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 28 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00174928


Sponsors and Collaborators
Takeda
Investigators
Study Director: Medical Director Takeda

Additional Information:
Publications:
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 ( Registry Identifier: WHO )
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: July 22, 2010
Last Verified: July 2010

Keywords provided by Takeda:
Pediatric GERD
Pediatric Gastroesophageal Reflux Disease
Neonates
lansoprazole

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