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Purified Cortrophin® Gel Efficacy and Safety Study of 2 Dose Levels in Patients With Acute Gout Flares

NCT07346079 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-01-20

No results posted yet for this 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

  • Gout Arthritis
  • Gout Flare
  • Gout

Interventions

DRUG

Purified Cortophin Gel, 40 U

This will be the 40 U dose of the purified Cortophin Gel

DRUG

Purified Cortophin Gel 80 U

This will be the 80 U dose of the purified Cortophin Gel

Sponsors & Collaborators

  • ANI Pharmaceuticals

    collaborator INDUSTRY

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Hyon K Choi, MD, DrPH · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-20
Primary Completion
2027-08-31
Completion
2027-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07346079 on ClinicalTrials.gov