A Non-inferiority, Multicenter and Randomized, Multiple-Dose Study About a Treatment to Hypolactasia
- Registration Number
- NCT01145586
- Lead Sponsor
- Eurofarma Laboratorios S.A.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 140
- 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).
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Lactase EUF Lactase Oral Tablets 1 oral tablet of the test drug before breakfast, lunch and dinner for 42 consecutive days Lactase Ref Lactase Oral Tablets 1 oral tablet of the comparative drug before breakfast, lunch and dinner for 42 consecutive days
- Primary Outcome Measures
Name Time Method Hydrogen value in the expired air 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).
- Secondary Outcome Measures
Name Time Method Signs and Symptoms Diary 42 days * 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.
Trial Locations
- Locations (8)
Hospital Israelita Albert Einstein
🇧🇷São Paulo, SP, Brazil
Instituto Goiano de Gastroenterologia
🇧🇷Goiânia, GO, Brazil
Hospital Mãe de Deus
🇧🇷Porto Alegre, RS, Brazil
Instituto Alfa de Gastroenterologia
🇧🇷Belo Horizonte, MG, Brazil
Hospital Nossa Senhora das Graças
🇧🇷Curitiba, PR, Brazil
Faculdade de Medicina do ABC
🇧🇷Santo André, SP, Brazil
Hospital São Paulo / UNIFESP
🇧🇷São Paulo, SP, Brazil
Hospital São Lucas
🇧🇷Porto Alegre, RS, Brazil