Back to results

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

Primary Purpose

Lactose Intolerance

Status

Completed

Phase

Phase 3

Locations

Brazil

Study Type

Interventional

Intervention

Lactase Oral Tablets

About this trial

This is an interventional treatment trial for Lactose Intolerance

Eligibility Criteria

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

Inclusion Criteria:

To have participated in the single-dose clinical study (EF099) previously performed, with the clinical response being considered as satisfactory by the investigator
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).

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Lactase EUF

Lactase Ref

Arm Description

1 oral tablet of the test drug before breakfast, lunch and dinner for 42 consecutive days

1 oral tablet of the comparative drug before breakfast, lunch and dinner for 42 consecutive days

Outcomes

Primary Outcome Measures

Hydrogen value in the expired air

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

Signs and Symptoms Diary

Signs and Symptoms Diary, registered for the period between V0 and V1 / V1 and V2; The Specific Symptom Score registered during the tests of hydrogen in the expired air; Global Evaluation of the Treatment Tolerance by the patient and the investigator; Frequency of adverse events noted.

Full Information

NCT ID

NCT01145586

First Posted

June 15, 2010

Last Updated

June 26, 2012

Sponsor

Eurofarma Laboratorios S.A.

1. Study Identification

Unique Protocol Identification Number

NCT01145586

Brief Title

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

Acronym

LAILAII

Official Title

A Phase III, Non-Inferiority, Randomized, Blind, Parallel-Group, Multicentre, Multiple-Dose, Comparative Clinical Study of Lactase Eurofarma and Lactaid®, Assessing the Efficacy and Safety in the Treatment of Patients With Lactose Intolerance"

Study Type

Interventional

2. Study Status

Record Verification Date

June 2010

Overall Recruitment Status

Completed

Study Start Date

June 2011 (undefined)

Primary Completion Date

March 2012 (Actual)

Study Completion Date

May 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 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.

6. Conditions and Keywords

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

Lactose Intolerance

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 oral tablet of the test drug before breakfast, lunch and dinner for 42 consecutive days

Arm Title

Lactase Ref

Arm Type

Active Comparator

Arm Description

1 oral tablet of the comparative drug before breakfast, lunch and dinner for 42 consecutive days

Intervention Type

Drug

Intervention Name(s)

Lactase Oral Tablets

Intervention Description

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

Primary Outcome Measure Information:

Title

Hydrogen value in the expired air

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

Secondary Outcome Measure Information:

Title

Signs and Symptoms Diary

Description

Time Frame

42 days

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: To have participated in the single-dose clinical study (EF099) previously performed, with the clinical response being considered as satisfactory by the investigator 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: