Trials / Completed
CompletedNCT01145339
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)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 140 (actual)
- Sponsor
- Eurofarma Laboratorios S.A. · Industry
- Sex
- All
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Not accepted
Summary
The study primary objective is to compare the clinical efficacy of two formulations in the supportive treatment of lactose intolerance.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Lactase | 1 chewable tablet of the test drug or comparative drug 30 minutes before the standard lactose dose (25 g). |
Timeline
- Start date
- 2011-07-01
- Primary completion
- 2011-11-01
- Completion
- 2012-03-01
- First posted
- 2010-06-16
- Last updated
- 2012-06-26
Locations
7 sites across 1 country: Brazil
Source: ClinicalTrials.gov record NCT01145339. Inclusion in this directory is not an endorsement.