Trials / Completed
CompletedNCT01951326
Efficacy and Safety of Anti-MAP Therapy in Adult Crohn's Disease
A Randomized, Double Blind, Placebo-controlled, Multicenter, Parallel Group Study to Assess the Efficacy and Safety of Fixed-dose Combination RHB-104 in Subjects With Moderately to Severely Active Crohn's Disease
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 331 (actual)
- Sponsor
- RedHill Biopharma Limited · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The investigators hypothesize that RHB-104 will have greater efficacy than placebo in Crohn's disease.
Detailed description
A Randomized, Double Blind, Placebo-controlled, Multicenter, Parallel Group Study to Assess the Efficacy and Safety of Fixed-dose Combination RHB-104 in Subjects with Moderately to Severely Active Crohn's Disease.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | RHB-104 | 95 mg clarithromycin, 45 mg rifabutin, and 10 mg clofazimine |
| DRUG | Placebo | 5 placebo capsules administered orally BID |
Timeline
- Start date
- 2013-09-01
- Primary completion
- 2018-05-01
- Completion
- 2019-08-01
- First posted
- 2013-09-26
- Last updated
- 2020-12-08
- Results posted
- 2020-05-01
Locations
103 sites across 10 countries: United States, Australia, Bulgaria, Canada, Czechia, Israel, New Zealand, Poland, Serbia, Slovakia
Source: ClinicalTrials.gov record NCT01951326. Inclusion in this directory is not an endorsement.