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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eurofarma Laboratorios S.A.
ClinicalTrials.gov Identifier:
NCT01145339
First received: June 15, 2010
Last updated: June 22, 2012
Last verified: October 2011

June 15, 2010
June 22, 2012
July 2011
November 2011   (final data collection date for primary outcome measure)
Hydrogen value in the air expired [ 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).
Hydrogen value in the air expired [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01145339 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Non-inferiority, Multicenter and Randomized, Single-Dose Study About a Treatment to Hypolactasia (LAILAI)
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Hypolactasia
Drug: Lactase
1 chewable tablet of the test drug or comparative drug 30 minutes before the standard lactose dose (25 g).
  • Experimental: Lactase EUF
    1 chewable tablet of the test drug 30 minutes before the standard lactose dose (25 g).
    Intervention: Drug: Lactase
  • Active Comparator: Lactase Ref
    1 chewable tablet of the comparative drug 30 minutes before the standard lactose dose (25 g).
    Intervention: Drug: Lactase
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
140
March 2012
November 2011   (final data collection date for primary outcome measure)

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).
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01145339
EF099
Yes
Eurofarma Laboratorios S.A.
Eurofarma Laboratorios S.A.
Not Provided
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
Eurofarma Laboratorios S.A.
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP