Trials / Completed
CompletedNCT02280629
Phosphatidylcholine (LT-02) vs. Placebo vs. Mesalamine for Maintenance of Remission in Ulcerative Colitis (PROTECT-2)
Randomized, Double-blind, Double-dummy, Placebo-controlled, Phase III Clinical Trial on the Efficacy and Safety of a 48-weeks Treatment With Gastro-resistant Phosphatidylcholine (LT-02) Versus Placebo Versus Mesalamine for Maintenance of Remission in Patients With Ulcerative Colitis
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 150 (actual)
- Sponsor
- Dr. Falk Pharma GmbH · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to prove the superiority of a 48-weeks treatment with 3.2 g/day delayed-release phosphatidylcholine (LT-02) versus placebo for the maintenance of remission in patients with ulcerative colitis (UC)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | LT-02 | LT-02 1.6g twice daily AND mesalamine PLACEBO three-times daily |
| DRUG | Placebo | LT-02 PLACEBO twice daily AND mesalamine PLACEBO three-times daily |
| DRUG | Mesalamine | LT-02 PLACEBO twice daily AND mesalamine 500mg three-times daily |
Timeline
- Start date
- 2014-10-01
- Primary completion
- 2018-10-05
- Completion
- 2018-10-05
- First posted
- 2014-10-31
- Last updated
- 2020-01-27
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT02280629. Inclusion in this directory is not an endorsement.