Purified Cortrophin® Gel Efficacy and Safety Study of 2 Dose Levels in Patients With Acute Gout Flares
Recruiting
Phase 4
Interventional Study
Gout Arthritis
Gout Flare
Gout
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 90
- Sex
- Any
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 150 (estimated)
- Sponsor
- Massachusetts General Hospital · Other
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About This Trial
This is a randomized, multicenter, double-blind, single administration study to investigate the efficacy and safety of 2 dosing regimens of Purified Cortrophin® Gel in the treatment of an acute gouty arthritis flare.
The study consists of three periods: an optional pre-screening period, a double-blind treatment period, and a 7-day follow-up period.
The treatment period is double-blind, and the p…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Signed informed consent to participate in this study
* Male and female patients, aged 18-85 years
* Meeting the 2015 Gout classification criteria of the ACR/EULAR collaborative initiative
* Onset of current acute gout flare within 5 days prior to study entry
* Body mass index …
Contacts