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

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.

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Key information

Conditions

Lactose Intolerance Carbohydrate Metabolism, Inborn Errors Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Gastrointestinal Diseases Genetic Diseases, Inborn Intestinal Diseases Malabsorption Syndromes Metabolic Diseases Metabolism, Inborn Errors Nutritional and Metabolic Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Instituto Goiano de Gastroenterologia, Goiânia, Goiás, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Lactase Oral Tablets

Drug

3 tablets/day for 42 days Take with breakfast, lunch and dinner

Primary outcomes

Hydrogen value in the expired air

Time frame: 03 times

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).

Secondary outcomes

Signs and Symptoms Diary

Time frame: 42 days
- 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.

Sponsors and collaborators

Lead sponsor

Eurofarma Laboratorios S.A.

Industry

Registry information

Official study 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"

Acronym: LAILAII

Important dates

Study start: 2011
Primary completion: 2012
Study completion: 2012
First posted: Jun 16, 2010
Registry last updated: Jun 28, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed