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NCT05658575 · ClinicalTrials.gov registry record · Phase 2
Study of Dapansutrile Tablets in Subjects With an Acute Gout Flare
A Phase 2 study of Arthritis and Gout, sponsored by Olatec Therapeutics.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 300
- Enrollment target
- 20
- Study locations
NCT05658575: Recruiting Phase 2 study of Arthritis and Gout, sponsored by Olatec Therapeutics.
NCT05658575 is a Phase 2 study of Arthritis and Gout that is actively recruiting participants, run by Olatec Therapeutics. The registered enrollment target is 300 participants, below the 4,504-participant average among 48 other Arthritis trials with a reported enrollment target (93% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05658575, a Phase 2 study of Arthritis and Gout, is actively recruiting participants, sponsored by Olatec Therapeutics.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 300 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this trial is to investigate the efficacy and safety of dapansutrile (OLT1177®) tablets in subjects with an acute gout flare.
Primary Outcome
Change from baseline in the subject-assessed pain intensity score evaluated on a 100-mm visual analogue scale (VAS) in the target joint at 72 hours post initial loading dose for dapansutrile compared to placebo. The visual analog scale has anchors of 0 indicating no pain and 100 indicating the worst pain.
Conditions Studied
Interventions
- DRUG Dapansutrile
- OTHER Placebo Tablet
Study Locations (20)
Florida
- Hillcrest Medical Research - DeLand
- SIMEDHealth - Gainesville
- University of Florida Health Jacksonville - Jacksonville
- Well Pharma Medical Research - Miami
- Clinical Research of West Florida - Tampa
California
- American Institute of Research - Los Angeles
- TriWest Research Associates - San Diego
- Valiance Clinical Research - Tarzana - Tarzana
Arizona
- Arizona Arthritis & Rheumatology Associates - Glendale - Glendale
- Arizona Arthritis & Rheumatology Associates (AARA), P.C. - Mesa - Mesa
Illinois
- Great Lakes Clinical Trials - Chicago
- Advanced Quality Medical Research - Orland Park
New York
- NYU Langone - New York
- IMA Clinical Research - Manhattan - New York
Alabama
- University of Alabama at Birmingham - Birmingham
Georgia
- Arthritis Center of North Georgia - Gainesville - Gainesville
Kentucky
- The Research Group of Lexington - Lexington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2023-01-06 |
| Est. Completion | 2027-01-31 |
| Phase | Phase 2 |
What NCT05658575 shows while recruiting
NCT05658575 is an interventional study that assigns participants to a tested intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, below the 4,504-participant average among 48 other Arthritis trials with a reported enrollment target (93% lower).
The record links to 7 conditions, with Arthritis appearing as the primary indexed condition, and to 2 interventions - of which Dapansutrile is the first listed.
NCT05658575 names 20 study sites across 11 states, led by Florida, California, Arizona.
Frequently Asked Questions
What is clinical trial NCT05658575 about?
NCT05658575 is a clinical study titled "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.
What is the current status of trial NCT05658575?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 300 participants. The study started on 2023-01-06. Estimated completion is 2027-01-31.
What conditions does trial NCT05658575 study?
This clinical trial studies the following conditions: Arthritis, Gout, Joint Pain, Gout Flare, Acute Gout Flare.
What interventions are being tested in trial NCT05658575?
The interventions under investigation include: Dapansutrile (DRUG), Placebo Tablet (OTHER).
Who is sponsoring clinical trial NCT05658575?
This trial is sponsored by Olatec Therapeutics, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05658575 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05658575's enrollment target sits among peer trials
300 16th of 48 higher than 32 of 48 other Arthritis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Arthritis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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