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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Lactose Intolerance

Intervention / Treatment
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* Drug: Lactase Oral Tablets


Participation Criteria
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Eligibility Criteria
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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: 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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lactase EUF<br>1 oral tablet of the test drug before breakfast, lunch and dinner for 42 consecutive days | Drug: Lactase Oral Tablets<br>* 3 tablets/day for 42 days Take with breakfast, lunch and dinner<br>|
| Active Comparator: Lactase Ref<br>1 oral tablet of the comparative drug before breakfast, lunch and dinner for 42 consecutive days | Drug: Lactase Oral Tablets<br>* 3 tablets/day for 42 days Take with breakfast, lunch and dinner<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Signs and Symptoms Diary | 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. | 42 days |