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Dapansutrile for Gout

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Clinical Trial Site, Birmingham, ALGout+6 MoreDapansutrile - Drug
Eligibility
18+
All Sexes
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Study Summary

This trial will test if a new drug is safe and effective for treating acute gout flare-ups.

Eligible Conditions
  • Gout
  • Arthritis
  • Gout Flare
  • Gout Attack

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

1 Primary · 11 Secondary · Reporting Duration: 12, 24, 36, 48 and 60 hours; 8 and 15 days

Day 15
Change in joint pain in the target joint at scheduled time points post initial loading dose of study drug
15 days
Electrocardiograms
To assess and compare changes in relevant circulating inflammatory biomarkers between dapansutrile and placebo.
To assess the clinical activity of dapansutrile compared to placebo in treating signs and symptoms of an acute gout flare other than pain (tenderness, swelling, erythema, warmth, and range of motion).
Day 15
To further assess the clinical activity of dapansutrile compared to placebo in reducing joint pain at scheduled time points post initial loading dose of IMP.
72 hours
To evaluate the efficacy of dapansutrile as an acute gout flare treatment compared to placebo in reducing joint pain at 72 hours post initial loading dose of IMP
8 and 15 days
To assess the clinical activity of dapansutrile compared to placebo in treating signs and symptoms of an acute gout flare other than pain (tenderness, swelling, erythema, warmth, and range of motion)
Up to 15 days
Physical examinations
Safety laboratory measurements
Vital signs
Up to 36 days
Adverse events
up to 15 days
To characterize the population PK of dapansutrile and exposure-response relationship for efficacy and safety.

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

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Trial Design

2 Treatment Groups

Dapansutrile
1 of 2
Placebo Tablet
1 of 2

Experimental Treatment

Non-Treatment Group

300 Total Participants · 2 Treatment Groups

Primary Treatment: Dapansutrile · Has Placebo Group · Phase 2 & 3

Dapansutrile
Drug
Experimental Group · 1 Intervention: Dapansutrile · Intervention Types: Drug
Placebo Tablet
Other
PlaceboComparator Group · 1 Intervention: Placebo Tablet · Intervention Types: Other

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 12, 24, 36, 48 and 60 hours; 8 and 15 days

Who is running the clinical trial?

Olatec Therapeutics LLCLead Sponsor
8 Previous Clinical Trials
498 Total Patients Enrolled
Mustafa Noor, MD, FACPStudy DirectorOlatec Therapeutics LLC
2 Previous Clinical Trials
60 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

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References

Frequently Asked Questions

What is the enrollment size of this investigation?

"Affirmative, the clinicaltrials.gov database reveals that this medical study is still enrolling participants. Initially posted on 6th January 2022 and last updated 9th July 2023, 300 patients are needed to be recruited from one centre alone." - Anonymous Online Contributor

Unverified Answer

Is there still opportunity for enrollment in this experiment?

"Yes, the published details on clinicaltrials.gov suggest that this trial is in progress and actively seeking participants. The study was originally posted on June 1st 2022 and amended most recently on September 1st 2023; it desires to recruit 300 patients from a single medical centre." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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