Study of Dapansutrile Tablets in Subjects With an Acute Gout Flare
A legfontosabb adatok
- Hol
- Amarillo, Ann Arbor, Birmingham, Bothell, Chicago, DeLand, Duncansville, Gainesville, Glendale, Jacksonville, Lexington, Los Angeles, Mesa, Miami, Missoula, New York, Orland Park, Salt Lake City, San Diego, Spokane, Summerville, Tampa és Tarzana (Egyesült Államok)Mind a 25 helyszín megnézése
- Fázis
- 2/3. fázis
Helyszínek itt: Egyesült Államok
- Amarillo Center of Clinical ResearchAmarillo, Egyesült ÁllamokContact: Vallen WhiteRésztvevőt keres
- University of MichiganAnn Arbor, Egyesült ÁllamokContact: Philip PiscitelliNo longer taking part
- University of Alabama at BirminghamBirmingham, Egyesült ÁllamokContact: Philip PiscitelliNo longer taking part
- Bothell, WashingtonHospital not named in the registryContact: Philip PiscitelliNo longer taking part
- Great Lakes Clinical TrialsChicago, Egyesült ÁllamokContact: Philip PiscitelliNo longer taking part
- Hillcrest Medical ResearchDeLand, Egyesült ÁllamokContact: Larry MoulderRésztvevőt keres
- Altoona ResearchDuncansville, Egyesült ÁllamokContact: Philip PiscitelliNo longer taking part
- Arthritis Center of North Georgia - GainesvilleGainesville, Egyesült ÁllamokContact: Cindy ValenzuelaRésztvevőt keres
- SIMEDHealthGainesville, Egyesült ÁllamokContact: Brandy Donahue-QuailsRésztvevőt keres
- Arizona Arthritis & Rheumatology Associates - GlendaleGlendale, Egyesült ÁllamokContact: Rebecca MartinezRésztvevőt keres
- University of Florida Health JacksonvilleJacksonville, Egyesült ÁllamokContact: Shannon LloydRésztvevőt keres
- The Research Group of LexingtonLexington, Egyesült ÁllamokContact: Philip PiscitelliNo longer taking part
- American Institute of ResearchLos Angeles, Egyesült ÁllamokContact: Philip PiscitelliNo longer taking part
- Arizona Arthritis & Rheumatology Associates (AARA), P.C. - MesaMesa, Egyesült ÁllamokContact: Swati Bharadwaj, MD (principal investigator)Résztvevőt keres
- Well Pharma Medical ResearchMiami, Egyesült ÁllamokContact: Ramon Perez LandaburoRésztvevőt keres
- Montana Medical ResearchMissoula, Egyesült ÁllamokContact: Eve HickeyRésztvevőt keres
- Ima Clinical Research ManhattanNew York, Egyesült ÁllamokContact: Philip PiscitelliNo longer taking part
- NYU LangoneNew York, Egyesült ÁllamokContact: Philip PiscitelliNo longer taking part
- Advanced Quality Medical ResearchOrland Park, Egyesült ÁllamokContact: Selahaddin HocaogluRésztvevőt keres
- Utah Health - University of Utah HospitalSalt Lake City, Egyesült ÁllamokContact: Julieanne HallRésztvevőt keres
- Triwest Research AssociatesSan Diego, Egyesült ÁllamokContact: Lennette FontelarRésztvevőt keres
- Arthritis NorthwestSpokane, Egyesült ÁllamokContact: Terri ConeRésztvevőt keres
- Lower Country Rheumatology - SummervilleSummerville, Egyesült ÁllamokContact: Eleanor GardzallaRésztvevőt keres
- Clinical Research of West FloridaTampa, Egyesült ÁllamokContact: Jocelyn EvansRésztvevőt keres
- Valiance Clinical Research - TarzanaTarzana, Egyesült ÁllamokContact: Gail MaRésztvevőt keres
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakA vizsgálat adatai
- Ki végzi
- Olatec Therapeutics, Inc.
- Azonosító
- NCT05658575EU 2024-518844-20-00
- A regiszteradat frissítve
- 2026. március 11.
- Eredeti leírás
The purpose of this trial is to investigate the efficacy and safety of dapansutrile (OLT1177®) tablets in subjects with an acute gout flare.A teljes eredeti leírásKevesebb
A Multi-Center Phase 2/3 Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Safety and Efficacy Study of Dapansutrile Tablets in Subjects With an Acute Gout Flare
The purpose of this trial is to investigate the efficacy and safety of dapansutrile (OLT1177®) tablets in subjects with an acute gout flare.
Bevonási feltételek: Male and female subjects age 18 or older; Clinical diagnosis of gout according to the 2015 ACR/EULAR Gout Classification Criteria:; 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; 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.
Kizáró feltételek: 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; 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; 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 would interfere with the subject's ability to accurately assess pain in the target joint.