A Study to Evaluate the Effect of Lansoprazole on Infants With Gastroesophageal Reflux Disease.
|ClinicalTrials.gov Identifier: NCT00220818|
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : July 22, 2010
|Condition or disease||Intervention/treatment||Phase|
|Gastroesophageal Reflux Disease||Drug: Lansoprazole||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Experimental: Lansoprazole 1.0 mg/kg QD||
Lansoprazole 1.0 mg/kg/day suspension, orally, once daily for up to 5 days.
|Experimental: Lansoprazole 2.0 mg/kg QD||
Lansoprazole 2.0 mg/kg/day suspension, orally, once daily for up to 5 days.
- Pharmacokinetic Analysis. [ Time Frame: Day 1 and 5 ]
- Mean Intragastric 24 hour pH (subset of 6 subjects) [ Time Frame: Day -1, 1 and 5 ]
- Gastroesophageal Reflux Disease Symptom Assessment. [ Time Frame: Days 1-5 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00220818
|Study Director:||Medical Director||Takeda|