Phase 2
N=127
A Study of AC-201 Controlled-Release Tablet (CR Tablet) in Patients With Gout
Gout
Bottom Line
View on ClinicalTrials.gov: NCT02287818 ↗Enrolled (actual)
127
Serious AEs
0.0%
Results posted
Oct 2020
Primary outcome: Primary: Proportion of Subjects Achieving Serum Uric Acid Concentration <6.0 mg/dL — 33; 43 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Placebo (Drug); AC-201 (Drug); Febuxostat (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- TWi Biotechnology, Inc.
- Primary completion
- Oct 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Subjects Achieving Serum Uric Acid Concentration <6.0 mg/dL |
33; 43 | — |
Summary
The study is designed to test the urate-lowering effect, safety, and tolerability of AC-201CR in an initial dosing period, followed by the addition of a ULT to test the efficacy and safety of the combination and prophylaxis of gout flares during ULT.
Eligibility Criteria
Inclusion Criteria
- Male or female age 20 to 65 years, inclusive.
- Meets ≥6 of the 12 American College of Rheumatology preliminary criteria (1977) for the classification of acute arthritis of primary gout (Appendix 2), OR have proven tophus or documented monosodium urate (MSU) crystals in the joint fluid.
- Serum uric acid ≥7.5 mg/dL and ≤10 mg/dL at screening with ≥1 gouty arthritis flare within one year prior to screening, OR serum uric acid ≥9 mg/dL and ≤10 mg/dL at screening with or without prior gout flares.
Exclusion Criteria
- Use of allopurinol, febuxostat, benzbromarone, probenecid, or sulfinpyrazone within 2 weeks prior to screening.
- Occurrence of a gouty arthritis flare within 1 week prior to screening or during the screening period through baseline.
- Use of colchicine within 1 week prior to screening.
- Use of Glucocorticoids, NSAIDs or COX-2 inhibitors within 1 week prior to screening.
- Allergy, contraindication, or intolerance to febuxostat.
- Severe renal impairment.
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) concentration >2 times the upper limit of laboratory normal range (>2x ULN) at screening.
Data sourced from ClinicalTrials.gov (NCT02287818). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.