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Purified Cortrophin® Gel Efficacy and Safety Study of 2 Dose Levels in Patients With Acute Gout Flares
NCT07346079 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07346079
The ClinicalTrials.gov registry entry for NCT07346079 describes a study currently listed as recruiting. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Massachusetts General Hospital, which has 1,948 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT07346079 reports 1 study location spanning 1 distinct geographic area — top geographies include Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07346079?
This trial is sponsored by Massachusetts General Hospital, which has 1,948 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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