Phase 2
Completed N=127
A Study of AC-201 Controlled-Release Tablet (CR Tablet) in Patients With Gout
Source: ClinicalTrials.gov NCT02287818 ↗Enrolled (actual)
127
Serious AEs
0.0%
Results posted
Oct 2020
Primary outcomePrimary: Proportion of Subjects Achieving Serum Uric Acid Concentration <6.0 mg/dL — 33; 43 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Subjects Achieving Serum Uric Acid Concentration <6.0 mg/dL |
33; 43 | — |
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. Informational only — not medical advice.