Trials / Completed
CompletedNCT02330796
Bucillamine for the Treatment of Acute Gout Flare in Subjects With Moderate to Severe Gout
A RANDOMIZED, MULTICENTRE PHASE IIa OPEN-LABEL, ACTIVE-COMPARATOR TRIAL TO ASSESS THE EFFICACY AND SAFETY OF TWO REGIMENS OF BUCILLAMINE 100 MG TABLETS AS COMPARED TO COLCHICINE 0.6 MG TABLETS FOR THE TREATMENT OF AN ACUTE GOUT FLARE IN SUBJECTS WITH MODERATE TO SEVERE GOUT.
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 66 (actual)
- Sponsor
- Revive Therapeutics, Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
A Phase IIA, open-label, multicenter, active-controlled, parallel-group clinical trial designed to evaluate the safety and efficacy of two doses of Bucillamine compared with low-dose Colchicine in the treatment of patients with acute gout flare.
Detailed description
To evaluate the safety and tolerability of two regimens of Bucillamine 100 mg (900 mg and 1,800 mg) over seven days of treatment compared with Colchicine 0.6 mg (1.8 mg) in the treatment of patients with acute gout flare
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Bucillamine | Bucillamine Tablets |
| DRUG | Colchicine |
Timeline
- Start date
- 2015-04-01
- Primary completion
- 2015-11-01
- Completion
- 2015-11-01
- First posted
- 2015-01-05
- Last updated
- 2016-10-05
Locations
3 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02330796. Inclusion in this directory is not an endorsement.