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

This study has been completed.
Sponsor:
Information provided by:
Takeda
ClinicalTrials.gov Identifier:
NCT00220818
First received: September 9, 2005
Last updated: July 20, 2010
Last verified: July 2010

September 9, 2005
July 20, 2010
January 2005
July 2005   (final data collection date for primary outcome measure)
  • Pharmacokinetic Analysis. [ Time Frame: Day 1 and 5 ] [ Designated as safety issue: No ]
  • Mean Intragastric 24 hour pH (subset of 6 subjects) [ Time Frame: Day -1, 1 and 5 ] [ Designated as safety issue: No ]
Pharmacokinetic, pharmacodynamic and safety parameters.
Complete list of historical versions of study NCT00220818 on ClinicalTrials.gov Archive Site
Gastroesophageal Reflux Disease Symptom Assessment. [ Time Frame: Days 1-5 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
A Study to Evaluate the Effect of Lansoprazole on Infants With Gastroesophageal Reflux Disease.
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.

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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Gastroesophageal Reflux Disease
  • Drug: Lansoprazole
    Lansoprazole 1.0 mg/kg/day suspension, orally, once daily for up to 5 days.
  • Drug: Lansoprazole
    Lansoprazole 2.0 mg/kg/day suspension, orally, once daily for up to 5 days.
  • Experimental: Lansoprazole 1.0 mg/kg QD
    Intervention: Drug: Lansoprazole
  • Experimental: Lansoprazole 2.0 mg/kg QD
    Intervention: Drug: Lansoprazole

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
July 2005
July 2005   (final data collection date for primary outcome measure)

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
Both
up to 364 Days
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00220818
C03-043, U1111-1114-0294
No
Sr. VP Clinical Sciences, Takeda Global Research & Development Center, Inc.
Takeda
Not Provided
Study Director: Medical Director Takeda
Takeda
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP