Status:
COMPLETED
A Non-inferiority, Multicenter and Randomized, Multiple-Dose Study About a Treatment to Hypolactasia
Lead Sponsor:
Eurofarma Laboratorios S.A.
Conditions:
Lactose Intolerance
Eligibility:
All Genders
18-60 years
Phase:
PHASE3
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 int...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
June 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT01145586
Start Date
June 1 2011
End Date
May 1 2012
Last Update
June 28 2012
Active Locations (8)
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1
Instituto Goiano de Gastroenterologia
Goiânia, Goiás, Brazil
2
Instituto Alfa de Gastroenterologia
Belo Horizonte, Minas Gerais, Brazil
3
Hospital Nossa Senhora das Graças
Curitiba, Paraná, Brazil
4
Hospital São Lucas
Porto Alegre, Rio Grande do Sul, Brazil, 90610-000