A Non-inferiority, Multicenter and Randomized, Single-Dose Study About a Treatment to Hypolactasia (LAILAI) (EF099)

A Phase III, Non-Inferiority, Randomized, Double-Blind, Parallel-Group, Multicentre, Single-Dose, Comparative Clinical Study of Lactase Eurofarma (Test Drug) and Lactaid® (Comparative Drug), Assessing the Efficacy and Safety in the Treatment of Patients With Lactose Intolerance (Hypolactasia)

The study primary objective is to compare the clinical efficacy of two formulations in the supportive treatment of lactose intolerance.

Study Overview

• Status: Completed
• Conditions: Hypolactasia
• Intervention / Treatment: Drug: Lactase

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

Contacts and Locations

Study Locations

• Brazil
  • GO
    • Goiania, GO, Brazil
      • Instituto Goiano de Gastroenterologia
  • MG
    • Belo Horizonte, MG, Brazil
      • Instituto Alfa de Gastroenterologia
  • PR
    • Curitiba, PR, Brazil
      • Hospital Nossa Senhora das Graças
  • RS
    • Porto Alegre, RS, Brazil, 90610-000
      • Hospital Sao Lucas
    • Porto Alegre, RS, Brazil
      • Hospital Mae de Deus
  • SP
    • Santo André, SP, Brazil
      • Faculdade de Medicina do ABC
    • São Paulo, SP, Brazil
      • Hospital São Paulo / UNIFESP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. The patient should be a male or female, aged between 18 and 60 years old;
2. Have a medical history consistent with lactose intolerance, confirmed by the test of hydrogen in the expired air;
3. The female patients should agree to use birth control methods during the study participation;
4. To be able to meet the study instructions and all the visits required;
5. To give a free consent to participate in the study and sign the informed consent form (ICF).

Exclusion Criteria:

1. Smoking;
2. Secondary hypolactasia;
3. Gastrointestinal inflammatories diseases - present diverticular disease, diabetic gastropathy or neoplasias;
4. Colonoscopy or colon cleaning procedure 4 weeks before the start of study
5. Latrogenic: unnoticed intake of laxatives in over-the-counter drugs or alternative medicine, intake of cereal bran or probiotics;
6. Diagnosis of HIV, immunodepression of any origin, or cancer under treatment.
7. 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),
8. 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;
9. Incapacity to understand and complete the study questionnaires, including the questions that require the use of the Visual Analogue Scale and ICF;
10. Pregnancy or lactation;
11. Use of alcohol, exceeding 3 doses daily;
12. Participation in another clinical study on the last 12 months;
13. 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 chewable tablet of the test drug 30 minutes before the standard lactose dose (25 g).	Drug: Lactase; 1 chewable tablet of the test drug or comparative drug 30 minutes before the standard lactose dose (25 g).
Active Comparator: Lactase Ref; 1 chewable tablet of the comparative drug 30 minutes before the standard lactose dose (25 g).	Drug: Lactase; 1 chewable tablet of the test drug or comparative drug 30 minutes before the standard lactose dose (25 g).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hydrogen value in the air expired	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

Collaborators and Investigators

• Sponsor: Eurofarma Laboratorios S.A.
• Investigators: Principal Investigator: Aderson Damião, M.D, Hospital das Clínicas de São Paulo; Principal Investigator: Heda Amarante, M.D, Hospital Nossa Senhora das Graças; Principal Investigator: Marta Machado, M.D, Hospital Sao Lucas PUCRS; Principal Investigator: Sender Miszputen, M.D, Hospital São Paulo / UNIFESP; Principal Investigator: Wilson Catapani, M.D, Faculdade de Medicina do ABC; Principal Investigator: Mauro Bafutto, M.D, Instituto Goiano de Gastroenterologia; Principal Investigator: Carlos Francesconi, M.D, Hospital Mae de Deus; Principal Investigator: Maria do Carmo Passos, M.D, Instituto Alfa de Gastroenterologia de BH

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): November 1, 2011
• Study Completion (Actual): March 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 26, 2012
• Last Update Submitted That Met QC Criteria: June 22, 2012
• Last Verified: October 1, 2011

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No