NCT01145586CompletedPhase 3
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"
Eurofarma Laboratorios S.A.8 sites in 1 country140 target enrollmentStarted: June 2011Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 140
- Locations
- 8
- Primary Endpoint
- Hydrogen value in the expired air
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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 & Interventions
Lactase EUF
Experimental
1 oral tablet of the test drug before breakfast, lunch and dinner for 42 consecutive days
Intervention: Lactase Oral Tablets (Drug)
Lactase Ref
Active Comparator
1 oral tablet of the comparative drug before breakfast, lunch and dinner for 42 consecutive days
Intervention: Lactase Oral Tablets (Drug)
Outcomes
Primary Outcomes
Hydrogen value in the expired air
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).
Secondary Outcomes
- Signs and Symptoms Diary(42 days)
Investigators
Study Sites (8)
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