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.
2 other identifiers
interventional
24
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jan 2005
Shorter than P25 for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 9, 2005
CompletedFirst Posted
Study publicly available on registry
September 22, 2005
CompletedJuly 22, 2010
July 1, 2010
6 months
September 9, 2005
July 20, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Pharmacokinetic Analysis.
Day 1 and 5
Mean Intragastric 24 hour pH (subset of 6 subjects)
Day -1, 1 and 5
Secondary Outcomes (1)
Gastroesophageal Reflux Disease Symptom Assessment.
Days 1-5
Study Arms (2)
Lansoprazole 1.0 mg/kg QD
EXPERIMENTALLansoprazole 2.0 mg/kg QD
EXPERIMENTALInterventions
Lansoprazole 1.0 mg/kg/day suspension, orally, once daily for up to 5 days.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Related Publications (2)
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.
PMID: 18590344RESULTZhang 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.
PMID: 18590345RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Takeda
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 9, 2005
First Posted
September 22, 2005
Study Start
January 1, 2005
Primary Completion
July 1, 2005
Study Completion
July 1, 2005
Last Updated
July 22, 2010
Record last verified: 2010-07