NCT01145586

A Non-inferiority, Multicenter and Randomized, Multiple-Dose Study About a Treatment to Hypolactasia

A Phase III, Non-Inferiority, Randomized, Blind, Parallel-Group, Multicentre, Multiple-Dose, Comparative Clinical Study of Lactase Eurofarma and Lactaid®, Assessing the Efficacy and Safety in the Treatment of Patients With Lactose Intolerance"

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: Eurofarma Laboratorios S.A. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The primary objective is to determine the compared clinical efficacy of Lactase Eurofarma (test drug), showing non-inferiority to Lactaid® (comparative drug) in the supportive treatment of lactose intolerance and to assess the safety and tolerance of Lactase Eurofarma (test drug) in the supportive treatment of lactose intolerance.

Conditions

• Lactose Intolerance

Interventions

Type	Name	Description
DRUG	Lactase Oral Tablets	3 tablets/day for 42 days Take with breakfast, lunch and dinner

Timeline

• Start date: 2011-06-01
• Primary completion: 2012-03-01
• Completion: 2012-05-01
• First posted: 2010-06-16
• Last updated: 2012-06-28

Locations

8 sites across 1 country: Brazil