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New gout pill aims to stop flare pain in 3 days

NCT ID NCT05658575

Symptom relief Sponsor: Olatec Therapeutics LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether dapansutrile tablets can reduce joint pain from an acute gout flare better than a placebo. About 300 adults with confirmed gout will take the drug or a dummy pill for 7 days. The main goal is to see if pain drops significantly within 72 hours of the first dose.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
dapansutrile (also called OLT1177) tablets
What this could lead to
If it works, this could provide a new, non-steroid option to quickly ease severe gout flare pain.
What could go wrong
This is an early-to-mid stage trial with only 300 participants. The drug may not work better than placebo, and side effects are still being studied.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2023

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 ≥ 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 OLT1177® 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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Conditions

The condition(s) this trial relates to.

Arthralgia arthritic joint disease Arthritis, Gouty gout Hyperuricemia Inflammation

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute gout flare Arthritis Gout Gout attack Gout flare Gouty arthritis Joint pain

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    30 sites in 5 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Advanced Quality Medical Research

    RECRUITING

    Orland Park, Illinois, 60462, United States

  • Altoona Research

    WITHDRAWN

    Duncansville, Pennsylvania, 16635, United States

  • Amarillo Center of Clinical Research

    RECRUITING

    Amarillo, Texas, 79124, United States

  • American Institute of Research

    WITHDRAWN

    Los Angeles, California, 90017, United States

  • Arizona Arthritis & Rheumatology Associates (AARA), P.C. - Mesa

    RECRUITING

    Mesa, Arizona, 85210, United States

  • Arizona Arthritis & Rheumatology Associates - Glendale

    RECRUITING

    Glendale, Arizona, 85306, United States

  • Arthritis Center of North Georgia - Gainesville

    RECRUITING

    Gainesville, Georgia, 30501, United States

  • Arthritis Northwest

    RECRUITING

    Spokane, Washington, 99204, United States

  • CHU de Rouen - Hôpital Charles-Nicolle

    RECRUITING

    Rouen, France

  • Carmel Medical Center

    RECRUITING

    Haifa, 3436212, Israel

  • Centre Hospitalier Universitaire de Bordeaux - Hôpital Pellegrin

    RECRUITING

    Bordeaux, 33076, France

  • Clinical Research of West Florida

    RECRUITING

    Tampa, Florida, 33765, United States

  • Clinical Trial Site

    WITHDRAWN

    Bothell, Washington, 98021, United States

  • Emek Medical Center

    RECRUITING

    Afula, Israel

  • Great Lakes Clinical Trials

    WITHDRAWN

    Chicago, Illinois, 60640, United States

  • Hillcrest Medical Research

    RECRUITING

    DeLand, Florida, 32720, United States

  • Hospital Universitario Infanta Leonor

    RECRUITING

    Madrid, 28031, Spain

  • Hospital Universitario de La Princesa

    RECRUITING

    Madrid, 28006, Spain

  • Hospital Universitario san Juan de Alicante

    WITHDRAWN

    Alicante, 03010, Spain

  • Hospital de la Santa Creu i Sant Pau

    RECRUITING

    Barcelona, 08025, Spain

  • Hôpital Lariboisière

    RECRUITING

    Paris, France

  • Hôpital Saint Philibert

    RECRUITING

    Lomme, 59462, France

  • IMA Clinical Research - Manhattan

    WITHDRAWN

    New York, New York, 10036, United States

  • Lower Country Rheumatology - Summerville

    RECRUITING

    Summerville, South Carolina, 29486, United States

  • Maastricht Universitair Medisch Centrum

    RECRUITING

    Maastricht, 6229 HX, Netherlands

  • Montana Medical Research

    RECRUITING

    Missoula, Montana, 59808, United States

  • NYU Langone

    ACTIVE_NOT_RECRUITING

    New York, New York, 10016, United States

  • Rabin Medical Center - Beilinson and Hasharon

    RECRUITING

    Petah Tikva, 49100, Israel

  • Reade Research BV

    RECRUITING

    Amsterdam, Netherlands

  • SIMEDHealth

    RECRUITING

    Gainesville, Florida, 32607,, United States

  • The Chaim Sheba Medical Center

    RECRUITING

    Ramat Gan, 5266202, Israel

  • The Research Group of Lexington

    ACTIVE_NOT_RECRUITING

    Lexington, Kentucky, 40503, United States

  • TriWest Research Associates

    RECRUITING

    San Diego, California, 92108, United States

  • University of Alabama at Birmingham

    WITHDRAWN

    Birmingham, Alabama, 35294, United States

  • University of Florida Health Jacksonville

    RECRUITING

    Jacksonville, Florida, 32256, United States

  • University of Michigan

    WITHDRAWN

    Ann Arbor, Michigan, 48109, United States

  • Utah Health - University of Utah Hospital

    RECRUITING

    Salt Lake City, Utah, 84108, United States

  • Valiance Clinical Research - Tarzana

    RECRUITING

    Tarzana, California, 91356, United States

  • VieCuri Medisch Centrum

    RECRUITING

    Venlo, Netherlands

  • Well Pharma Medical Research

    RECRUITING

    Miami, Florida, 33173, United States

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