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

NCT01145586 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2012-06-28

No results posted yet for this study

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

DRUG

Lactase Oral Tablets

3 tablets/day for 42 days Take with breakfast, lunch and dinner

Sponsors & Collaborators

  • Eurofarma Laboratorios S.A.

    lead INDUSTRY

Principal Investigators

  • Marta Machado, M.D · Hospital São Lucas / PUCRS

  • Heda Amarante, M.D · Hospital Nossa Senhora das Graças

  • Sender Miszputen, M.D · Hospital São Paulo/UNIFESP

  • Wilson Catapani, M.D · Faculdade de Medicina do ABC

  • Mauro Bafutto, M.D · Instituto Goiano de Gastroenterologia

  • Carlos Fernando Francesconi, M.D · Hospital Mãe de Deus

  • Maria do Carmo Passos, M.D · Instituto Alfa de Gastroenterologia de BH

  • Flavio Steinwurtz, MD · Hospital Israelita Albert Eisntein

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2012-03-31
Completion
2012-05-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01145586 on ClinicalTrials.gov