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

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ClinicalTrials.gov Identifier: NCT00220818
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : July 22, 2010
Sponsor:
Information provided by:
Takeda

Study Description
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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, 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 Design
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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, Multicenter Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety of Lansoprazole in Infants With Clinically-Evident Gastroesophageal Reflux Disease.
Study Start Date : January 2005
Actual Primary Completion Date : July 2005
Actual Study Completion Date : July 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD
U.S. FDA Resources

Arms and Interventions
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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.
Experimental: Lansoprazole 2.0 mg/kg QD Drug: Lansoprazole
Lansoprazole 2.0 mg/kg/day suspension, orally, once daily for up to 5 days.


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

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

Eligibility Criteria
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Ages Eligible for Study:   up to 364 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT00220818


Sponsors and Collaborators
Takeda
Investigators
Study Director: Medical Director Takeda
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
FDA Safety Alerts and Recalls  This link exits the ClinicalTrials.gov site

Publications of Results:

Responsible Party: Sr. VP Clinical Sciences, Takeda Global Research & Development Center, Inc.
ClinicalTrials.gov Identifier: NCT00220818     History of Changes
Other Study ID Numbers: C03-043
U1111-1114-0294 ( Registry Identifier: WHO )
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: July 22, 2010
Last Verified: July 2010

Keywords provided by Takeda:
Pediatric GERD
Pediatric Gastroesophageal Reflux Disease
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