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โ† Trials
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Study of Dapansutrile Tablets in Subjects With an Acute Gout Flare

RecruitingPhase 2, Phase 3Ages 18 Years - anyAllOlatec Therapeutics, Inc.
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In plain words

What the trial is, and whether it could suit you

The purpose of this trial is to investigate the efficacy and safety of dapansutrile (OLT1177ยฎ) tablets in subjects with an acute gout flare.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Male and female subjects age 18 or older * Clinical diagnosis of gout according to the 2015 ACR/EULAR Gout Classification Criteria: A) Diagnosis of gout must be confirmed in the target joint as indicated by either the presence of monosodium urate (MSU) crystals by microscopic evaluation of synovial fluid from the target joint or bursa OR by imaging evidence of urate deposition in the target joint or bursa at the Screening/Baseline Visit/Study Day 1, or B) Documented history in the target joint or bursa ; or documented history of 2 or more gout flares in the previous 18 months * Confirmation of a gout flare in the target joint that began within 96 hours prior to the Screening/Baseline Visit * Provide written informed consent and understand and comply with all trial requirements Exclusion Criteria: * Presence of any palpable and visible tophi by physical examination * Has โ‰ฅ 4 joints with an acute gout flare at Screening/Baseline * Presence of active rheumatoid arthritis or other acute inflammatory arthritis * Evidence/suspicion of infectious/septic arthritis * Clinically significant general pain or non-gout-related joint pain that would interfere with the subject's ability to accurately assess pain in the target joint * Known diagnosis of chronic kidney disease or known history of renal impairment * Positive test for severe acute respiratory syndrome coronavirus 2 (SARS- CoV-2) infection, if tested, within 4 weeks of the Screening/Baseline * Active malignancy or recent malignancy with any systemic anti-cancer treatment * Has a hypersensitivity or allergy to OLT1177ยฎ or other drugs in its class * Hypersensitivity or allergy to paracetamol/acetaminophen * Use of any prohibited concomitant medications/therapies over the periods defined in the protocol or planned use of any prohibited concomitant medications/therapies during the Treatment Period (including the use of paracetamol/acetaminophen within 4 hours prior to the Screening/Baseline Visit or other pain medications within 12 hours prior to the Screening/ Baseline Visit * Use of any product containing paracetamol/acetaminophen within 4 hours prior to the Screening/Baseline Visit or planned use during the Treatment Period (with the exception of study-provided Rescue Medication \[paracetamol/acetaminophen\], which is permitted after completion of the first target joint pain assessment on Study Day 4
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What it tests

  • Dapansutrile
  • Placebo Tablet
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Where

40 sites
University of Alabama at Birmingham
Birmingham, United States
Arizona Arthritis & Rheumatology Associates - Glendale
Glendale, United States
Arizona Arthritis & Rheumatology Associates (AARA), P.C. - Mesa
Mesa, United States
American Institute of Research
Los Angeles, United States
TriWest Research Associates
San Diego, United States
Valiance Clinical Research - Tarzana
Tarzana, United States
Hillcrest Medical Research
DeLand, United States
SIMEDHealth
Gainesville, United States

โ€ฆand 32 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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