drugset / Trial / NCT00229424

Verification Study on Lafutidine in Mild Reflux Oesophagitis - Double Blind Controlled Study With Famotidine -

NCT00229424

Phase 3 Completed 325 enrolled Taiho Pharmaceutical Co., Ltd. UCB Pharma · collab
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of the study is to verify superiority of the lafutidine group over the placebo group and non-inferiority to the famotidine group in terms of endoscopic healing rate of the patients with mild reflux oesophagitis. Furthermore, the followings are compared: The improvement effect in heartburn and other subjective symptoms, and dosing frequency of MALFA ® suspension (neutralizer) as well as incidence of adverse events among the lafutidine 20 mg/day treatment group, the famotidine 40 mg/day treatment group and the placebo treatment group in patients with mild reflux oesophagitis.

Timeline

Start
2005-04
Primary completion
2006-10
Completion
2007-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Famotidine Other / unclassified 40 mg Oral
Subject Lafutidine Small molecule 20 mg Oral