Clinical Trial: A Non-inferiority, Multicenter and Randomized, Multiple-Dose Study About a Treatment to Hypolactasia
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
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
Brief 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.
Detailed Summary:
Sponsor: Eurofarma Laboratorios S.A.
Current Primary Outcome: Hydrogen value in the expired air [ Time Frame: 03 times ]
Original Primary Outcome: Hydrogen value in the expired air
Current Secondary Outcome: Signs and Symptoms Diary [ Time Frame: 42 days ]
- 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.
Original Secondary Outcome: 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.
Information By: Eurofarma Laboratorios S.A.
Dates:
Date Received: June 15, 2010
Date Started: June 2011
Date Completion:
Last Updated: June 26, 2012
Last Verified: June 2010
