Clinical trial NCT01145586: A Non-inferiority, Multicenter and Randomized, Multiple-Dose Study About a Treatment to Hypolactasia
Official title: 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"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Lactose Intolerance
Lead sponsor: Eurofarma Laboratorios S.A.
Sponsor class: INDUSTRY
First posted: 2010-06-16
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Hydrogen value in the expired air
timeFrame: 03 times
Secondary outcomes:
measure: Signs and Symptoms Diary
timeFrame: 42 days
Other outcomes:
Locations:
city: Goiânia
country: Brazil
facility: Instituto Goiano de Gastroenterologia
state: GO
city: Belo Horizonte
country: Brazil
facility: Instituto Alfa de Gastroenterologia
state: MG
city: Curitiba
country: Brazil
facility: Hospital Nossa Senhora das Graças
state: PR
city: Porto Alegre
country: Brazil
facility: Hospital São Lucas
state: RS
city: Porto Alegre
country: Brazil
facility: Hospital Mãe de Deus
state: RS
city: Santo André
country: Brazil
facility: Faculdade de Medicina do ABC
state: SP
city: São Paulo
country: Brazil
facility: Hospital Israelita Albert Einstein
state: SP
city: São Paulo
country: Brazil
facility: Hospital São Paulo / UNIFESP
state: SP
Study officials:
affiliation: Hospital São Lucas / PUCRS
name: Marta Machado, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Nossa Senhora das Graças
name: Heda Amarante, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital São Paulo/UNIFESP
name: Sender Miszputen, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculdade de Medicina do ABC
name: Wilson Catapani, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto Goiano de Gastroenterologia
name: Mauro Bafutto, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Mãe de Deus
name: Carlos Fernando Francesconi, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto Alfa de Gastroenterologia de BH
name: Maria do Carmo Passos, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Israelita Albert Eisntein
name: Flavio Steinwurtz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.