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

• ClinicalTrials.gov Identifier: NCT01145339
• Recruitment Status: Completed
• First Posted: June 16, 2010
• Last Update Posted: June 26, 2012
• Sponsor: Eurofarma Laboratorios S.A.
• Information provided by (Responsible Party): Eurofarma Laboratorios S.A.

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Hypolactasia	Drug: Lactase	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 140 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• 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 Start Date: July 2011
• Actual Primary Completion Date: November 2011
• Actual Study Completion Date: March 2012

Arms and Interventions

Arm	Intervention/treatment
Experimental: Lactase EUF; 1 chewable tablet of the test drug 30 minutes before the standard lactose dose (25 g).	Drug: Lactase; 1 chewable tablet of the test drug or comparative drug 30 minutes before the standard lactose dose (25 g).
Active Comparator: Lactase Ref; 1 chewable tablet of the comparative drug 30 minutes before the standard lactose dose (25 g).	Drug: Lactase; 1 chewable tablet of the test drug or comparative drug 30 minutes before the standard lactose dose (25 g).

Outcome Measures

Primary Outcome Measures :

1. 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).

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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).

Contacts and Locations

Locations

Brazil

Instituto Goiano de Gastroenterologia

Goiania, GO, Brazil

Instituto Alfa de Gastroenterologia

Belo Horizonte, MG, Brazil

Hospital Nossa Senhora das Graças

Curitiba, PR, Brazil

Hospital São Lucas

Porto Alegre, RS, Brazil, 90610-000

Hospital Mãe de Deus

Porto Alegre, RS, Brazil

Faculdade de Medicina do ABC

Santo André, SP, Brazil

Hospital São Paulo / UNIFESP

São Paulo, SP, Brazil

Sponsors and Collaborators

Eurofarma Laboratorios S.A.

Investigators

• Principal Investigator: Aderson Damião, M.D; Hospital das Clínicas de São Paulo
• Principal Investigator: Heda Amarante, M.D; Hospital Nossa Senhora das Graças
• Principal Investigator: Marta Machado, M.D; Hospital São Lucas PUCRS
• Principal Investigator: Sender Miszputen, M.D; Hospital São Paulo / UNIFESP
• Principal Investigator: Wilson Catapani, M.D; Faculdade de Medicina do ABC
• Principal Investigator: Mauro Bafutto, M.D; Instituto Goiano de Gastroenterologia
• Principal Investigator: Carlos Francesconi, M.D; Hospital Mãe de Deus
• Principal Investigator: Maria do Carmo Passos, M.D; Instituto Alfa de Gastroenterologia de BH

More Information

• Responsible Party: Eurofarma Laboratorios S.A.
• ClinicalTrials.gov Identifier: NCT01145339
• Other Study ID Numbers: EF099
• First Posted: June 16, 2010
• Last Update Posted: June 26, 2012
• Last Verified: October 2011

Additional relevant MeSH terms:

Lactose Intolerance; Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Carbohydrate Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Metabolic Diseases