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

NCT01145586 | Completed Phase 3 DMC

• 1 other identifier: EF099-2
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 8

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.

Conditions

Lactose Intolerance

Outcome Measures

Primary Outcomes (1)

• 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).

  03 times

Secondary Outcomes (1)

• Signs and Symptoms Diary

  42 days

Study Arms (2)

Lactase EUF

EXPERIMENTAL

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

Drug: Lactase Oral Tablets

Lactase Ref

ACTIVE COMPARATOR

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

Drug: Lactase Oral Tablets

Interventions

Lactase Oral Tablets DRUG

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

Lactase EUF; Lactase Ref

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Eurofarma Laboratorios S.A.: lead

Study Sites (8)

Instituto Goiano de Gastroenterologia

Goiânia, Goiás, Brazil

Location

Instituto Alfa de Gastroenterologia

Belo Horizonte, Minas Gerais, Brazil

Location

Hospital Nossa Senhora das Graças

Curitiba, Paraná, Brazil

Location

Hospital São Lucas

Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

Location

Hospital Mãe de Deus

Porto Alegre, Rio Grande do Sul, Brazil

Location

Faculdade de Medicina do ABC

Santo André, São Paulo, Brazil

Location

Hospital Israelita Albert Einstein

São Paulo, São Paulo, Brazil

Location

Hospital São Paulo / UNIFESP

São Paulo, São Paulo, Brazil

Location

Related Publications (1)

• Francesconi CF, Machado MB, Steinwurz F, Nones RB, Quilici FA, Catapani WR, Miszputen SJ, Bafutto M. ORAL ADMINISTRATION OF EXOGENOUS LACTASE IN TABLETS FOR PATIENTS DIAGNOSED WITH LACTOSE INTOLERANCE DUE TO PRIMARY HYPOLACTASIA. Arq Gastroenterol. 2016 Oct-Dec;53(4):228-234. doi: 10.1590/S0004-28032016000400004.

  PMID: 27706451 DERIVED

MeSH Terms

Conditions

Lactose Intolerance

Interventions

Lactase

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Carbohydrate Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

beta-Galactosidase; Galactosidases; Glycoside Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes

Study Officials

• Marta Machado, M.D

  Hospital São Lucas / PUCRS

  PRINCIPAL INVESTIGATOR

• Heda Amarante, M.D

  Hospital Nossa Senhora das Graças

  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 Fernando Francesconi, M.D

  Hospital Mãe de Deus

  PRINCIPAL INVESTIGATOR

• Maria do Carmo Passos, M.D

  Instituto Alfa de Gastroenterologia de BH

  PRINCIPAL INVESTIGATOR

• Flavio Steinwurtz, MD

  Hospital Israelita Albert Eisntein

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2010
• First Posted: June 16, 2010
• Study Start: June 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: May 1, 2012
• Last Updated: June 28, 2012

Record last verified: 2010-06

Locations

BR (8)