A Phase III, Non-Inferiority, Randomized, Double-Blind, Parallel-Group, Multicentre, Single-Dose, Comparative Clinical Study of Lactase Eurofarma (Test Drug) and Lactaid® (Comparative Drug), Assessing the Efficacy and Safety in the Treatment of Patients With Lactose Intolerance (Hypolactasia)

Eurofarma Laboratorios S.A.7 sites in 1 country140 target enrollmentJuly 2011

ConditionsHypolactasia

InterventionsLactase

DrugsLactase

Overview

Phase: Phase 3
Intervention: Lactase
Conditions: Hypolactasia
Sponsor: Eurofarma Laboratorios S.A.
Enrollment: 140
Locations: 7
Primary Endpoint: Hydrogen value in the air expired
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

July 2011

End Date

March 2012

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Eurofarma Laboratorios S.A.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•The patient should be a male or female, aged between 18 and 60 years old;
•Have a medical history consistent with lactose intolerance, confirmed by the test of hydrogen in the expired air;
•The female patients should agree to use birth control methods during the study participation;
•To be able to meet the study instructions and all the visits required;
•To give a free consent to participate in the study and sign the informed consent form (ICF).

Exclusion Criteria

•Secondary hypolactasia;
•Gastrointestinal inflammatories diseases - present diverticular disease, diabetic gastropathy or neoplasias;
•Colonoscopy or colon cleaning procedure 4 weeks before the start of study
•Latrogenic: unnoticed intake of laxatives in over-the-counter drugs or alternative medicine, intake of cereal bran or probiotics;
•Diagnosis of HIV, immunodepression of any origin, or cancer under treatment.
•Diagnosis of other comorbidity that, at the investigator's discretion, may compromise the study participation (e.g., systemic infection during the study or use of antibiotics in the last 4 weeks, diabetes mellitus, uncontrolled hypertension or renal failure),
•Hypersensitivity or previous laboratory or clinical adverse event related to the use of lactase or any of the components of the formulations used in the study;
•Incapacity to understand and complete the study questionnaires, including the questions that require the use of the Visual Analogue Scale and ICF;
•Pregnancy or lactation;
•Use of alcohol, exceeding 3 doses daily;

Arms & Interventions

Lactase EUF

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

Intervention: Lactase

Lactase Ref

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

Intervention: Lactase

Outcomes

Primary Outcomes

Hydrogen value in the air expired

Time Frame: 03 times

Hydrogen value in the expired air for 3h after the patient exposure to the standardized Lactose 25g dose with interventional exogenous Lactase (comparative and test drugs).