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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
140
3 tablets/day for 42 days Take with breakfast, lunch and dinner
Instituto Goiano de Gastroenterologia
Goiânia, Goiás, Brazil
Instituto Alfa de Gastroenterologia
Belo Horizonte, Minas Gerais, Brazil
Hospital Nossa Senhora das Graças
Curitiba, Paraná, Brazil
Hospital São Lucas
Porto Alegre, Rio Grande do Sul, Brazil
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).
Time frame: 03 times
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.
Time frame: 42 days
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Hospital Mãe de Deus
Porto Alegre, Rio Grande do Sul, Brazil
Faculdade de Medicina do ABC
Santo André, São Paulo, Brazil
Hospital Israelita Albert Einstein
São Paulo, São Paulo, Brazil
Hospital São Paulo / UNIFESP
São Paulo, São Paulo, Brazil