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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eurofarma Laboratorios S.A.
ClinicalTrials.gov Identifier:
NCT01145586
First received: June 15, 2010
Last updated: June 26, 2012
Last verified: June 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Lactose Intolerance
 Drug: Lactase Oral Tablets
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official 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"

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Eurofarma Laboratorios S.A.:

Primary Outcome Measures:
  • Hydrogen value in the expired air [ Time Frame: 03 times ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Signs and Symptoms Diary [ Time Frame: 42 days ] [ Designated as safety issue: Yes ]
    • 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.


Enrollment: 140
Study Start Date: June 2011
Study Completion Date: May 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01145586

Locations
Brazil
Instituto Goiano de Gastroenterologia
Goiânia, 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
Hospital Israelita Albert Einstein
São Paulo, SP, Brazil
Sponsors and Collaborators
Eurofarma Laboratorios S.A.
Investigators
Principal Investigator: Marta Machado, M.D Hospital São Lucas / PUCRS
Principal Investigator: Heda Amarante, M.D Hospital Nossa Senhora das Graças
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 Fernando Francesconi, M.D Hospital Mãe de Deus
Principal Investigator: Maria do Carmo Passos, M.D Instituto Alfa de Gastroenterologia de BH
Principal Investigator: Flavio Steinwurtz, MD Hospital Israelita Albert Eisntein
  More Information

No publications provided

Responsible Party: Eurofarma Laboratorios S.A.
ClinicalTrials.gov Identifier: NCT01145586     History of Changes
Other Study ID Numbers: EF099-2
Study First Received: June 15, 2010
Last Updated: June 26, 2012
Health Authority: Brazil: Ethics Committee
Brazil: National Health Surveillance Agency

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

ClinicalTrials.gov processed this record on June 18, 2013