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A Non-inferiority, Multicenter and Randomized, Single-Dose Study About a Treatment to Hypolactasia (LAILAI)

NCT01145339 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2012-06-26

No results posted yet for this study

Summary

The study primary objective is to compare the clinical efficacy of two formulations in the supportive treatment of lactose intolerance.

Conditions

  • Hypolactasia

Interventions

DRUG

Lactase

1 chewable tablet of the test drug or comparative drug 30 minutes before the standard lactose dose (25 g).

Sponsors & Collaborators

  • Eurofarma Laboratorios S.A.

    lead INDUSTRY

Principal Investigators

  • Aderson Damião, M.D · Hospital das Clínicas de São Paulo

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

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

  • 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 Francesconi, M.D · Hospital Mãe de Deus

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

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
2011-07-31
Primary Completion
2011-11-30
Completion
2012-03-31

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 NCT01145339 on ClinicalTrials.gov