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

Lactose Intolerance Clinical Trial

— LAILAII  

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"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01145586
• Other study ID #: EF099-2
• Status: Completed
• Phase: Phase 3
• First received: June 15, 2010
• Last updated: June 26, 2012
• Start date: June 2011
• Est. completion date: May 2012

Study information

• Verified date: June 2010
• Source: Eurofarma Laboratorios S.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics CommitteeBrazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: May 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lactose Intolerance

Intervention

Drug:
• Lactase Oral Tablets
3 tablets/day for 42 days Take with breakfast, lunch and dinner

Locations

Country	Name	City	State
Brazil	Instituto Alfa de Gastroenterologia	Belo Horizonte	MG
Brazil	Hospital Nossa Senhora das Graças	Curitiba	PR
Brazil	Instituto Goiano de Gastroenterologia	Goiânia	GO
Brazil	Hospital Mãe de Deus	Porto Alegre	RS
Brazil	Hospital São Lucas	Porto Alegre	RS
Brazil	Faculdade de Medicina do ABC	Santo André	SP
Brazil	Hospital Israelita Albert Einstein	São Paulo	SP
Brazil	Hospital São Paulo / UNIFESP	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Eurofarma Laboratorios S.A.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes