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

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"

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.

Study Overview

• Status: Completed
• Conditions: Lactose Intolerance
• Intervention / Treatment: Drug: Lactase Oral Tablets

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • GO
    • Goiânia, GO, Brazil
      • Instituto Goiano de Gastroenterologia
  • MG
    • Belo Horizonte, MG, Brazil
      • Instituto Alfa de Gastroenterologia
  • PR
    • Curitiba, PR, Brazil
      • Hospital Nossa Senhora Das Gracas
  • RS
    • Porto Alegre, RS, Brazil, 90610-000
      • Hospital sao lucas
    • Porto Alegre, RS, Brazil
      • Hospital Mãe de Deus
  • SP
    • Santo André, SP, Brazil
      • Faculdade de Medicina do ABC
    • São Paulo, SP, Brazil
      • Hospital São Paulo / UNIFESP
    • São Paulo, SP, Brazil
      • Hospital Israelita Albert Einstein

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lactase EUF; 1 oral tablet of the test drug before breakfast, lunch and dinner for 42 consecutive days	Drug: Lactase Oral Tablets; 3 tablets/day for 42 days Take with breakfast, lunch and dinner
Active Comparator: Lactase Ref; 1 oral tablet of the comparative drug before breakfast, lunch and dinner for 42 consecutive days	Drug: Lactase Oral Tablets; 3 tablets/day for 42 days Take with breakfast, lunch and dinner

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hydrogen value in the expired air	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).	03 times

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Signs and Symptoms Diary	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.	42 days

Collaborators and Investigators

• Sponsor: Eurofarma Laboratorios S.A.
• Investigators: Principal Investigator: Heda Amarante, M.D, Hospital Nossa Senhora Das Gracas; Principal Investigator: Wilson Catapani, M.D, Faculdade de Medicina do ABC; Principal Investigator: Mauro Bafutto, M.D, Instituto Goiano de Gastroenterologia; Principal Investigator: Maria do Carmo Passos, M.D, Instituto Alfa de Gastroenterologia de BH; Principal Investigator: Marta Machado, M.D, Hospital São Lucas / PUCRS; Principal Investigator: Sender Miszputen, M.D, Hospital São Paulo/UNIFESP; Principal Investigator: Carlos Fernando Francesconi, M.D, Hospital Mãe de Deus; Principal Investigator: Flavio Steinwurtz, MD, Hospital Israelita Albert Eisntein

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): March 1, 2012
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: June 15, 2010
• First Submitted That Met QC Criteria: June 15, 2010
• First Posted (Estimate): June 16, 2010

Study Record Updates

• Last Update Posted (Estimate): June 28, 2012
• Last Update Submitted That Met QC Criteria: June 26, 2012
• Last Verified: June 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Metabolic Diseases; Gastrointestinal Diseases; Genetic Diseases, Inborn; Intestinal Diseases; Carbohydrate Metabolism, Inborn Errors; Metabolism, Inborn Errors; Malabsorption Syndromes; Lactose Intolerance
• Other Study ID Numbers: EF099-2