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

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ClinicalTrials.gov Identifier: NCT01145339
Recruitment Status : Completed
First Posted : June 16, 2010
Last Update Posted : June 26, 2012
Sponsor:
Information provided by (Responsible Party):
Eurofarma Laboratorios S.A.

Study Description
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Brief Summary:
The study primary objective is to compare the clinical efficacy of two formulations in the supportive treatment of lactose intolerance.

Condition or disease Intervention/treatment Phase
Hypolactasia Drug: Lactase Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : July 2011
Actual Primary Completion Date : November 2011
Actual Study Completion Date : March 2012

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Arms and Interventions
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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).


Outcome Measures
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Primary Outcome Measures :
  1. Hydrogen value in the air expired [ 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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01145339


Locations
Brazil
Instituto Goiano de Gastroenterologia
Goiania, GO, Brazil
Instituto Alfa de Gastroenterologia
Belo Horizonte, MG, Brazil
Hospital Nossa Senhora das Graças
Curitiba, PR, Brazil
Hospital São Lucas
Porto Alegre, RS, Brazil, 90610-000
Hospital Mãe de Deus
Porto Alegre, RS, Brazil
Faculdade de Medicina do ABC
Santo André, SP, Brazil
Hospital São Paulo / UNIFESP
São Paulo, SP, Brazil
Sponsors and Collaborators
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 São 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 Mãe de Deus
Principal Investigator: Maria do Carmo Passos, M.D Instituto Alfa de Gastroenterologia de BH
More Information
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Responsible Party: Eurofarma Laboratorios S.A.
ClinicalTrials.gov Identifier: NCT01145339     History of Changes
Other Study ID Numbers: EF099
First Posted: June 16, 2010    Key Record Dates
Last Update Posted: June 26, 2012
Last Verified: October 2011

Additional relevant MeSH terms:
Lactose Intolerance
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
 Carbohydrate Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases