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

Eurofarma

Status and phase

Completed

Phase 3

Conditions

Lactose Intolerance

Treatments

Drug: Lactase Oral Tablets

Study type

Interventional

Funder types

Industry

Identifiers

NCT01145586

EF099-2

Details and patient eligibility

About

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.

Enrollment

140 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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).