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

NCT ID: NCT01145339

Last Updated: 2012-06-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2012-03-31

Brief Summary

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

Conditions

Hypolactasia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Lactase EUF

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

Group Type: EXPERIMENTAL

Lactase

Intervention Type: DRUG

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

Lactase Ref

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

Group Type: ACTIVE_COMPARATOR

Lactase

Intervention Type: DRUG

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

Interventions

Lactase

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. The patient should be a male or female, aged between 18 and 60 years old;

2. Have a medical history consistent with lactose intolerance, confirmed by the test of hydrogen in the expired air;

3. The female patients should agree to use birth control methods during the study participation;

4. To be able to meet the study instructions and all the visits required;

5. To give a free consent to participate in the study and sign the informed consent form (ICF).

Exclusion Criteria

1. Smoking;

2. Secondary hypolactasia;

3. Gastrointestinal inflammatories diseases - present diverticular disease, diabetic gastropathy or neoplasias;

4. Colonoscopy or colon cleaning procedure 4 weeks before the start of study

5. Latrogenic: unnoticed intake of laxatives in over-the-counter drugs or alternative medicine, intake of cereal bran or probiotics;

6. Diagnosis of HIV, immunodepression of any origin, or cancer under treatment.

7. 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),

8. 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;

9. Incapacity to understand and complete the study questionnaires, including the questions that require the use of the Visual Analogue Scale and ICF;

10. Pregnancy or lactation;

11. Use of alcohol, exceeding 3 doses daily;

12. Participation in another clinical study on the last 12 months;

13. 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eurofarma Laboratorios S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aderson Damião, M.D

Role: PRINCIPAL_INVESTIGATOR

Hospital das Clínicas de São Paulo

Heda Amarante, M.D

Role: PRINCIPAL_INVESTIGATOR

Hospital Nossa Senhora das Graças

Marta Machado, M.D

Role: PRINCIPAL_INVESTIGATOR

Hospital São Lucas PUCRS

Sender Miszputen, M.D

Role: PRINCIPAL_INVESTIGATOR

Hospital São Paulo / UNIFESP

Wilson Catapani, M.D

Role: PRINCIPAL_INVESTIGATOR

Faculdade de Medicina do ABC

Mauro Bafutto, M.D

Role: PRINCIPAL_INVESTIGATOR

Instituto Goiano de Gastroenterologia

Carlos Francesconi, M.D

Role: PRINCIPAL_INVESTIGATOR

Hospital Mãe de Deus

Maria do Carmo Passos, M.D

Role: PRINCIPAL_INVESTIGATOR

Instituto Alfa de Gastroenterologia de BH

Locations

Instituto Goiano de Gastroenterologia

Goiânia, Goiás, Brazil

Instituto Alfa de Gastroenterologia

Belo Horizonte, Minas Gerais, Brazil

Hospital Nossa Senhora das Graças

Curitiba, Paraná, Brazil

Hospital São Lucas

Porto Alegre, Rio Grande do Sul, Brazil

Hospital Mãe de Deus

Porto Alegre, Rio Grande do Sul, Brazil

Faculdade de Medicina do ABC

Santo André, São Paulo, Brazil

Hospital São Paulo / UNIFESP

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

EF099

Identifier Type: -

Identifier Source: org_study_id