Status:
COMPLETED
A Study of AC-201 Controlled-Release Tablet (CR Tablet) in Patients With Gout
Lead Sponsor:
TWi Biotechnology, Inc.
Conditions:
Gout
Eligibility:
All Genders
20-65 years
Phase:
PHASE2
Brief 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 comb...
Detailed Description
AC-201CR is a control released formulation of AC-201 that in previous clinical studies showed potential dual effects in both reducing serum uric acid (sUA) and gout flares. The mechanism of action of ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 27 2016
Estimated Enrollment :
127 Patients enrolled
Trial Details
Trial ID
NCT02287818
Start Date
December 1 2014
End Date
October 27 2016
Last Update
June 28 2022
Active Locations (1)
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1
Taipei Veteran General Hospital (TVGH)
Taipei, Taiwan, 112