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A Non-inferiority, Multicenter and Randomized, Single-Dose Study About a Treatment to Hypolactasia (LAILAI) (EF099)

Primary Purpose

Hypolactasia

Status

Completed

Phase

Phase 3

Locations

Brazil

Study Type

Interventional

Intervention

Lactase

About this trial

This is an interventional treatment trial for Hypolactasia

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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:

Smoking;
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;
Participation in another clinical study on the last 12 months;
Patient having some chronic pulmonary disease that, in the investigator's opinion, may harm or interfere with the expired hydrogen test (e.g., cystic fibrosis).

Sites / Locations

Instituto Goiano de Gastroenterologia
Instituto Alfa de Gastroenterologia
Hospital Nossa Senhora das Graças
Hospital São Lucas
Hospital Mãe de Deus
Faculdade de Medicina do ABC
Hospital São Paulo / UNIFESP

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Lactase EUF

Lactase Ref

Arm Description

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

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

Outcomes

Primary Outcome Measures

Hydrogen value in the air expired

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).

Secondary Outcome Measures

Full Information

NCT ID

NCT01145339

First Posted

June 15, 2010

Last Updated

June 22, 2012

Sponsor

Eurofarma Laboratorios S.A.

1. Study Identification

Unique Protocol Identification Number

NCT01145339

Brief Title

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

Acronym

EF099

Official Title

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)

Study Type

Interventional

2. Study Status

Record Verification Date

October 2011

Overall Recruitment Status

Completed

Study Start Date

July 2011 (undefined)

Primary Completion Date

November 2011 (Actual)

Study Completion Date

March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eurofarma Laboratorios S.A.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypolactasia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

140 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Lactase EUF

Arm Type

Experimental

Arm Description

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

Arm Title

Lactase Ref

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Lactase

Intervention Description

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

Primary Outcome Measure Information:

Title

Hydrogen value in the air expired

Description

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).

Time Frame

03 times

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

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: Smoking; 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; Participation in another clinical study on the last 12 months; Patient having some chronic pulmonary disease that, in the investigator's opinion, may harm or interfere with the expired hydrogen test (e.g., cystic fibrosis).

Overall Study Officials: