Trials / Completed
CompletedNCT01279577
Trichuris Suis Ova (TSO) Suspension Versus Placebo in Active Crohn's Disease
Double-blind, Randomised, Placebo-controlled, Multi-centre Phase II Study to Evaluate the Efficacy and Safety of Three Different Dosages of Oral Trichuris Suis Ova (TSO) Suspension in Active Crohn's Disease
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 254 (actual)
- Sponsor
- Dr. Falk Pharma GmbH · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
This study will run in centers in Germany, Denmark, Austria, Czech Republic, and Switzerland, only. This proof-of-concept study aims to evaluate the efficacy of three doses of oral TSO suspension vs. placebo for the induction of remission in Crohn's disease.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Low dose TSO | Low dose TSO suspension |
| DRUG | Medium dose TSO | Medium dose TSO suspension |
| DRUG | High dose TSO | High dose TSO suspension |
| DRUG | Placebo | Placebo solution |
Timeline
- Start date
- 2010-11-01
- Primary completion
- 2014-02-01
- Completion
- 2014-02-01
- First posted
- 2011-01-19
- Last updated
- 2015-02-10
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT01279577. Inclusion in this directory is not an endorsement.