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Corticosteroid

FX006 for Trochanteric Bursitis

Q: What is Zilretta typically prescribed to treat?

<p>Zilretta is widely used to treat <a href="https://www.withpower.com/clinical-trials/ulcerative-colitis">ulcerative colitis</a>, as well as more rare conditions such as hand and brain illnesses, and various dermatological issues.</p>

Phase 2

Waitlist Available

Led By Pritish Bawa, MD

Research Sponsored by The University of Texas Health Science Center, Houston

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline,week 12

Awards & highlights

Study Summary

This trial will test a new drug, Zilretta, to see if it is safe and effective for treating chronic pain. It will also assess how patients feel about changing to this new treatment.

Eligible Conditions

Trochanteric Bursitis

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline,week 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline,week 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline,week 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Pain From Baseline as Assessed by the Numeric Pain Rating Scale (NPRS) Score

Secondary outcome measures

Patient Global Impression of Change (PGIC) Score

Side effects data

From 2016 Phase 3 trial • 486 Patients • NCT02357459

14%

Arthralgia

Headache

Back Pain

Nasopharyngitis

Rectal Cancer

Atrial Fibrillation

Pneumonia:

Arthralgia:

Large Intestine Polyp

Dizziness

100%

80%

60%

40%

20%

Study treatment Arm

FX006 32mg

Placebo

TCA IR 40 mg

Trial Design

1Treatment groups

Experimental Treatment

Group I: FX006Experimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

FX006

2012

Completed Phase 3

~740

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Flexion Therapeutics, Inc.Industry Sponsor

19 Previous Clinical Trials

2,072 Total Patients Enrolled

Pacira PharmaceuticalsUNKNOWN

The University of Texas Health Science Center, HoustonLead Sponsor

904 Previous Clinical Trials

320,975 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is Zilretta typically prescribed to treat?

"Zilretta is widely used to treat ulcerative colitis, as well as more rare conditions such as hand and brain illnesses, and various dermatological issues."

Answered by AI

Is there still availability for participants in this research?

"This trial is no longer recruiting new participants. It was first published on August 12th 2020 and underwent its last modifications in October 4th 2022. If you are exploring other research studies, there are currently 37 trials for trochanteric bursitis and 41 clinical trials examining Zilretta that actively seek volunteers."

Answered by AI

How many test subjects are being recruited for this clinical experiment?

"This research is not currently open to recruitment. Initially posted on August 12th 2020, the clinical trial was most recently edited on October 4th 2022. However, there are presently 37 studies actively sourcing patients with trochanteric bursitis and 41 trials for Zilretta that are accepting participants."

Answered by AI

Has Zilretta received regulatory authorization from the FDA?

"Despite being a Phase 2 trial, which does not yet have any evidence of efficacy, Zilretta has been evaluated for safety and given an assessment score of 2."

Answered by AI

What other endeavors into Zilretta have been undertaken for clinical research?

"Presently, 41 research studies on Zilretta are underway. 8 of them being in the final stage (Phase 3). Whilst most trials for this therapy are situated in Columbia, Missouri, it's available at a total of 75 sites across the country."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study to Assess the Safety and Efficacy of FX006 Administered to Patients With Greater Trochanteric Bursitis

Pritish Bawa 2020. "Study to Assess the Safety and Efficacy of FX006 Administered to Patients With Greater Trochanteric Bursitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04182672.