Who is sponsoring NCT00324974?

NCT00324974 is sponsored by Takeda.

What condition does NCT00324974 study?

NCT00324974 studies Gastroesophageal Reflux Disease.

What drugs are being tested in NCT00324974?

Interventions: Lansoprazole microgranules suspension, Placebo.

What is the status of NCT00324974?

NCT00324974 is currently COMPLETED.

Last reviewed 2010-07-20 · How we verify

A Phase 3, Randomized, Multi-Center, Double-Blind, Placebo-Controlled, Parallel Group Study Assessing the Safety and Efficacy of Lansoprazole Microgranules Oral Suspension in Infants With Symptomatic Gastroesophageal Reflux

NCT00324974 Phase 3 COMPLETED

The purpose of this study is to assess the safety and efficacy of lansoprazole microgranules oral suspension, once daily (QD), in infants with gastroesophageal reflux symptoms during a 4-week treatment period.

Details

Lead sponsor	Takeda
Phase	Phase 3
Status	COMPLETED
Enrolment	162
Start date	2006-06
Completion	2007-05

Conditions

Gastroesophageal Reflux Disease

Interventions

Lansoprazole microgranules suspension
Placebo

Primary outcomes

Percentage of subjects in each treatment group responding to treatment with a reduction from baseline in the percentage and duration of crying/fussing/irritability episodes associated with feeding after 4 weeks of treatment. — Week 4
Safety Assessments — Baseline through week 8

Countries

United States, Poland