A Proof-of-Concept Study of AC-201 to Prevent Gout Flares
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ClinicalTrials.gov Identifier: NCT01712204 |
Recruitment Status
:
Completed
First Posted
: October 23, 2012
Results First Posted
: December 1, 2014
Last Update Posted
: December 1, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Gout Flares | Drug: Placebo Drug: AC-201 Drug: Febuxostat | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 82 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Prevention |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled Trial Of AC-201 In Subjects With Gout Initiating Urate-Lowering Therapy |
Study Start Date : | January 2013 |
Actual Primary Completion Date : | September 2013 |
Actual Study Completion Date : | September 2013 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: Placebo
Placebo plus Febuxostat
|
Drug: Placebo
Placebo Capsule BID for 16 Weeks
Other Name: PBO
Drug: Febuxostat
Febuxostat 80 mg QD for 16 Weeks
Other Name: ULT
|
Experimental: AC-201
AC-201 plus Febuxostat
|
Drug: AC-201
AC-201 50mg Capsule BID for 16 Weeks
Drug: Febuxostat
Febuxostat 80 mg QD for 16 Weeks
Other Name: ULT
|
- Number of Gout Flares Per Subject [ Time Frame: 16 weeks ]
- Proportion of Subjects Experiencing ≥1 or ≥2 Gout Flares [ Time Frame: 16 weeks ]
- Time to First Gout Flare [ Time Frame: 16 weeks ]
- Gout Flare Days Per Subject [ Time Frame: 16 weeks ]
- Duration of Gout Flares [ Time Frame: 16 weeks ]
- Change From Baseline in Serum Uric Acid Concentration [ Time Frame: 16 weeks ]
- Proportion of Subjects Achieving Serum Uric Acid Concentration <6.0 or <5.0 mg/dL [ Time Frame: 16 weeks ]
- Mean Pain Visual Analog Scale Score Associated With Gout Flares [ Time Frame: 16 weeks ]

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Ages Eligible for Study: | 20 Years to 80 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male or female age 20 to 80 years, inclusive
- Meets at least 6 of the 12 American College of Rheumatology preliminary criteria (1977) for the classification of acute arthritis of primary gout, OR have proven tophus or documented monosodium urate (MSU) crystals in the joint fluid
- Serum uric acid ≥7.5 mg/dL at screening
- Experienced ≥2 gouty arthritis flares within one year prior to screening
Exclusion Criteria:
- Occurrence of a gouty arthritis flare ongoing at screening or during the screening period through baseline
- Use of allopurinol, febuxostat, benzbromarone, probenecid, or sulfinpyrazone within 4 weeks prior to screening
- Use of colchicine, glucocorticoids, NSAIDs, or COX-2 inhibitors within 1 week prior to screening
- Other (non-gout) chronic arthritis, acute inflammatory arthritis, autoimmune diseases with arthritis, or any condition requiring chronic daily use of pain medication
- History of allergy to any components of study medication, including diacerein
- Allergy, contraindication, or intolerance to febuxostat
- Contraindication or allergy to NSAIDs
- Severe renal impairment
- Any prior use of biologic anti-inflammatory therapy, such as IL-1 modulators, tumor necrosis factor inhibitors, IL-6 inhibitors, or T-cell costimulation modulator

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): NCT01712204
Taiwan | |
Veterans General Hospital | |
Taipei, Taiwan |
Responsible Party: | TWi Biotechnology, Inc. |
ClinicalTrials.gov Identifier: | NCT01712204 History of Changes |
Other Study ID Numbers: |
AC-201-GOU-001 |
First Posted: | October 23, 2012 Key Record Dates |
Results First Posted: | December 1, 2014 |
Last Update Posted: | December 1, 2014 |
Last Verified: | November 2014 |
Keywords provided by TWi Biotechnology, Inc.:
Prophylaxis of Acute Gout Flares Urate-Lowering Therapy Hyperuricemia Gouty arthritis |
Additional relevant MeSH terms:
Gout Arthritis Joint Diseases Musculoskeletal Diseases Crystal Arthropathies Rheumatic Diseases Purine-Pyrimidine Metabolism, Inborn Errors |
Metabolism, Inborn Errors Genetic Diseases, Inborn Metabolic Diseases Febuxostat Gout Suppressants Antirheumatic Agents |