Status:
COMPLETED
A Non-inferiority, Multicenter and Randomized, Single-Dose Study About a Treatment to Hypolactasia (LAILAI)
Lead Sponsor:
Eurofarma Laboratorios S.A.
Conditions:
Hypolactasia
Eligibility:
All Genders
18-60 years
Phase:
PHASE3
Brief Summary
The study primary objective is to compare the clinical efficacy of two formulations in the supportive treatment of lactose intolerance.
Eligibility Criteria
Inclusion
- 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 :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT01145339
Start Date
July 1 2011
End Date
March 1 2012
Last Update
June 26 2012
Active Locations (7)
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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