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NCT07346079 · ClinicalTrials.gov registry record · Phase 4
Purified Cortrophin® Gel Efficacy and Safety Study of 2 Dose Levels in Patients With Acute Gout Flares
A Phase 4 study of Gout and Gout Flare, sponsored by Massachusetts General Hospital.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 150
- Enrollment target
- 1
- Study location
NCT07346079: Recruiting Phase 4 study of Gout and Gout Flare, sponsored by Massachusetts General Hospital.
NCT07346079 is a Phase 4 study of Gout and Gout Flare that is actively recruiting participants, run by Massachusetts General Hospital. The registered enrollment target is 150 participants, below the 8,884-participant average among 34 other Gout trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07346079, a Phase 4 study of Gout and Gout Flare, is actively recruiting participants, sponsored by Massachusetts General Hospital.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 150 participants
- Enrollment target
- 1
- Study location
Study Summary
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 patients will be randomized to treatment with 40 U Purified Cortrophin® Gel or 80 U Purified Cortrophin® Gel in a 1:1 ratio. Purified Cortrophin® Gel will be administered once (either subcutaneously or intramuscularly) on the first visit (Day 0; Visit 1) and surveyed after 24 hours (Day 1), 48 hours (Day 2), and 72 hours (Day 3; Visit 2) as well as on Day 7.
Primary Outcome
Change in gout pain intensity from baseline in the target joint following PCG administration measured by Visual Analog Scale (VAS) at 72 hours post-injection (Day 3; Visit 2). Patients will score their pain intensity in the joint most affected at baseline (i.e., the index joint) on a 0-100 mm visual analogue scale (VAS), ranging from no pain (0) to unbearable pain (100).
Conditions Studied
Interventions
- DRUG Purified Cortophin Gel, 40 U
- DRUG Purified Cortophin Gel 80 U
Study Locations (1)
Massachusetts
- Mass General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2025-12-20 |
| Est. Completion | 2027-08-31 |
| Phase | Phase 4 |
What NCT07346079 shows while recruiting
NCT07346079 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 8,884-participant average among 34 other Gout trials with a reported enrollment target (98% lower).
The record links to 3 conditions, with Gout appearing as the primary indexed condition, and to 2 interventions - of which Purified Cortophin Gel, 40 U is the first listed.
NCT07346079 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT07346079 about?
NCT07346079 is a clinical study titled "Purified Cortrophin® Gel Efficacy and Safety Study of 2 Dose Levels in Patients With Acute Gout Flares". 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-bl...
What is the current status of trial NCT07346079?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 150 participants. The study started on 2025-12-20. Estimated completion is 2027-08-31.
What conditions does trial NCT07346079 study?
This clinical trial studies the following conditions: Gout, Gout Flare, Gout Arthritis.
What interventions are being tested in trial NCT07346079?
The interventions under investigation include: Purified Cortophin Gel, 40 U (DRUG), Purified Cortophin Gel 80 U (DRUG).
Who is sponsoring clinical trial NCT07346079?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07346079 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT07346079's enrollment target sits among peer trials
150 15th of 34 higher than 19 of 34 other Gout trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Gout 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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