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A Study of AC-201 Controlled-Release Tablet (CR Tablet) in Patients With Gout

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ClinicalTrials.gov Identifier: NCT02287818
Recruitment Status : Completed
First Posted : November 11, 2014
Last Update Posted : April 7, 2017
Sponsor:
Information provided by (Responsible Party):
TWi Biotechnology, Inc.

Brief Summary:
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 actions of AC-201 include the inhibition of the production and activity of caspase-1 and interleukin-1β (IL-1β), and selective inhibition of re-absorption transporters in kidney. The goal of gout treatment is to reduce serum uric acid (sUA) concentrations below the urate solubility limit while avoiding acute gout flares. However, the initiation of urate-lowering therapy (ULT) increases the occurrence of acute gouty arthritis flares. IL-1β plays a key role in mediating this inflammatory response. The study is designed to test the urate-lowering effect, safety, and tolerability of AC-201CR in an initial dosing period, followed by addition of an ULT to test the efficacy and safety of the combination and prophylaxis of gout flares during ULT.

Condition or disease Intervention/treatment Phase
Gout Drug: Placebo Drug: AC-201 Drug: Febuxostat Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 127 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : December 2014
Actual Primary Completion Date : October 27, 2016
Actual Study Completion Date : October 27, 2016

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Gout
MedlinePlus related topics: Gout
Drug Information available for: Febuxostat

Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo plus Febuxostat
Drug: Placebo
Placebo twice daily from Day 1 to Week 12
Other Name: PBO

Drug: Febuxostat
Febuxostat 40 mg once daily from Week 4 to Week 16; titration to 80 mg once daily at Week 8 as needed to achieve serum uric acid concentration <6 mg/dL
Other Name: ULT

Experimental: AC-201
AC-201 CR tablet plus Febuxostat
Drug: AC-201
AC-201 CR tablet 100 mg twice daily from Day 1 to Week 12
Other Name: AC-201 CR tablet

Drug: Febuxostat
Febuxostat 40 mg once daily from Week 4 to Week 16; titration to 80 mg once daily at Week 8 as needed to achieve serum uric acid concentration <6 mg/dL
Other Name: ULT




Primary Outcome Measures :
  1. Proportion of Subjects Achieving Serum Uric Acid Concentration <6.0 mg/dL [ Time Frame: 8 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female age 20 to 65 years, inclusive.
  2. 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.
  3. 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:

  1. Use of allopurinol, febuxostat, benzbromarone, probenecid, or sulfinpyrazone within 2 weeks prior to screening.
  2. Occurrence of a gouty arthritis flare within 1 week prior to screening or during the screening period through baseline.
  3. Use of colchicine within 1 week prior to screening.
  4. Use of Glucocorticoids, NSAIDs or COX-2 inhibitors within 1 week prior to screening.
  5. Allergy, contraindication, or intolerance to febuxostat.
  6. Severe renal impairment.
  7. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) concentration >2 times the upper limit of laboratory normal range (>2x ULN) at screening.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02287818


Locations
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Taiwan
Taipei Veteran General Hospital (TVGH)
Taipei, Taiwan, 112
Sponsors and Collaborators
TWi Biotechnology, Inc.
Investigators
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Principal Investigator: Chang-Youh Tsai Taipei Veteran General Hospital (TVGH)

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Responsible Party: TWi Biotechnology, Inc.
ClinicalTrials.gov Identifier: NCT02287818     History of Changes
Other Study ID Numbers: AC-201-GOU-002
First Posted: November 11, 2014    Key Record Dates
Last Update Posted: April 7, 2017
Last Verified: April 2017

Additional relevant MeSH terms:
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Febuxostat
Gout Suppressants
Antirheumatic Agents