Phase
Condition
Musculoskeletal Diseases
Joint Injuries
Chronic Pain
Treatment
Placebo Tablet
Dapansutrile
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male and female subjects age 18 or older
Clinical diagnosis of gout according to the 2015 ACR/EULAR Gout ClassificationCriteria:
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 tothe Screening/Baseline Visit
Provide written informed consent and understand and comply with all trialrequirements
Exclusion
Exclusion Criteria:
Presence of any palpable and visible tophi by physical examination
Has ≥ 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 wouldinterfere 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 OLT1177® or other drugs in its class
Hypersensitivity or allergy to paracetamol/acetaminophen
Use of any prohibited concomitant medications/therapies over the periods defined inthe protocol or planned use of any prohibited concomitant medications/therapiesduring the Treatment Period (including the use of paracetamol/acetaminophen within 4hours prior to the Screening/Baseline Visit or other pain medications within 12hours prior to the Screening/ Baseline Visit
Use of any product containing paracetamol/acetaminophen within 4 hours prior to theScreening/Baseline Visit or planned use during the Treatment Period (with theexception of study-provided Rescue Medication [paracetamol/acetaminophen], which ispermitted after completion of the first target joint pain assessment on Study Day 4
Study Design
Study Description
Connect with a study center
Centre Hospitalier Universitaire de Bordeaux - Hôpital Pellegrin
Bordeaux, 33076
FranceActive - Recruiting
Hôpital Saint Philibert
Lomme, 59462
FranceActive - Recruiting
Hôpital Lariboisière
Paris,
FranceActive - Recruiting
CHU de Rouen - Hôpital Charles-Nicolle
Rouen,
FranceActive - Recruiting
Emek Medical Center
Afula,
IsraelSite Not Available
Reade Research BV
Amsterdam,
NetherlandsSite Not Available
VieCuri Medisch Centrum
Venlo,
NetherlandsSite Not Available
Clinical Trial Site
Alicante, 03010
SpainActive - Recruiting
Hospital general Universitario Dr. Balmis
Alicante, 03010
SpainActive - Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, 08025
SpainActive - Recruiting
Hospital Universitario Infanta Leonor
Madrid, 28031
SpainActive - Recruiting
Clinical Trial Site
Birmingham, Alabama 35294
United StatesActive - Recruiting
University of Alabama at Birmingham
Birmingham, Alabama 35294
United StatesActive - Recruiting
Clinical Trial Site
Anchorage, Alaska 99508
United StatesSite Not Available
Arizona Arthritis & Rheumatology Associates - Glendale
Glendale, Arizona 85306
United StatesActive - Recruiting
Clinical Trial Site
Glendale, Arizona 85306
United StatesActive - Recruiting
Arizona Arthritis & Rheumatology Associates (AARA), P.C. - Mesa
Mesa, Arizona 85210
United StatesActive - Recruiting
Clinical Trial Site
Mesa, Arizona 85210
United StatesActive - Recruiting
Clinical Trial Site
El Cajon, California 90017
United StatesSite Not Available
Clinical Trial Site
Lexington, California 40503
United StatesActive - Recruiting
American Institute of Research
Los Angeles, California 90017
United StatesActive - Recruiting
Clinical Trial Site
Los Angeles, California 92108
United StatesActive - Recruiting
TriWest Research Associates
San Diego, California 92108
United StatesActive - Recruiting
Clinical Trial Site
Summerville, California 29486
United StatesActive - Recruiting
Clinical Trial Site
Tarzana, California 91356
United StatesActive - Recruiting
Valiance Clinical Research - Tarzana
Tarzana, California 91356
United StatesActive - Recruiting
Clinical Trial Site
DeBary, Florida 32713
United StatesActive - Recruiting
Omega Research
DeBary, Florida 32713
United StatesSite Not Available
Clinical Trial Site
DeLand, Florida 32720
United StatesActive - Recruiting
Hillcrest Medical Research
DeLand, Florida 32720
United StatesActive - Recruiting
Clinical Trial Site
Jacksonville, Florida 32256
United StatesActive - Recruiting
University of Florida Health Jacksonville
Jacksonville, Florida 32256
United StatesActive - Recruiting
Well Pharma Medical Research
Miami, Florida 33173
United StatesActive - Recruiting
Clinical Research of West Florida
Tampa, Florida 33765
United StatesActive - Recruiting
Arthritis Center of North Georgia - Gainesville
Gainesville, Georgia 30501
United StatesActive - Recruiting
Clinical Trial Site
Thomasville, Georgia 31792
United StatesSite Not Available
Clinical Trial Site
Chicago, Illinois 60640
United StatesActive - Recruiting
Great Lakes Clinical Trials
Chicago, Illinois 60640
United StatesSite Not Available
Clinical Trial Site
Orland Park, Illinois 60462
United StatesActive - Recruiting
The Research Group of Lexington
Lexington, Kentucky 40503
United StatesActive - Recruiting
Clinical Trial Site
Ann Arbor, Michigan 48109
United StatesActive - Recruiting
University of Michigan
Ann Arbor, Michigan 48109
United StatesActive - Recruiting
Clinical Trial Site
Missoula, Montana 59808
United StatesActive - Recruiting
Montana Medical Research
Missoula, Montana 59808
United StatesActive - Recruiting
Clinical Trial Site
New York, New York 10016
United StatesActive - Recruiting
IMA Clinical Research - Manhattan
New York, New York 10036
United StatesActive - Recruiting
NYU Langone
New York, New York 10016
United StatesActive - Recruiting
Altoona Research
Duncansville, Pennsylvania 16635
United StatesSite Not Available
Clinical Trial Site
Duncansville, Pennsylvania 16635
United StatesActive - Recruiting
Lower Country Rheumatology - Summerville
Summerville, South Carolina 29486
United StatesActive - Recruiting
Amarillo Center of Clinical Research
Amarillo, Texas 79124
United StatesActive - Recruiting
Clinical Trial Site
Amarillo, Texas 79124
United StatesActive - Recruiting
Utah Health - University of Utah Hospital
Salt Lake City, Utah 84108
United StatesActive - Recruiting
Clinical Trial Site
Bothell, Washington 98021
United StatesSite Not Available
Arthritis Northwest
Spokane, Washington 99204
United StatesActive - Recruiting
Clinical Trial Site
Spokane, Washington 99204
United StatesActive - Recruiting
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