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

Phase 3 Completed 140 enrolled Eurofarma Laboratorios S.A.

RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start: 2011-06
Primary completion: 2012-03
Completion: 2012-05

Outcome

Met primary endpoint

paper The upper limit of the 95% CI did not exceed the a priori non-inferiority limit (7.5 ppm). PMID 27706451 ↗

paper The experimental product was non-inferior to the reference product, indicating that it was an effective replacement therapy for endogenous lactase in lactose intolerance patients. PMID 27706451 ↗

Publications

Francesconi CF, Machado MB, Steinwurz F, Nones RB, Quilici FA, Catapani WR, Miszputen SJ, Bafutto M. ORAL ADMINISTRATION OF EXOGENOUS LACTASE IN TABLETS FOR PATIENTS DIAGNOSED WITH LACTOSE INTOLERANCE DUE TO PRIMARY HYPOLACTASIA. Arq Gastroenterol. 2016 Oct-Dec;53(4):228-234. doi: 10.1590/S0004-28032016000400004.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lactaid	Unknown	1 unknown	Oral
Subject	Perlatte	Protein / enzyme biologic	1 unknown	Oral