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
|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 ]
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
|Study Director:||Medical Director||Takeda|