NCT04182672 is a Phase 2 clinical trial of FX006 in Trochanteric Bursitis, sponsored by The University of Texas Health Science Center, Houston.

Who is sponsoring NCT04182672?

NCT04182672 is sponsored by The University of Texas Health Science Center, Houston.

What drugs are being tested in NCT04182672?

Interventions in NCT04182672: FX006.

What condition does NCT04182672 study?

NCT04182672 studies Trochanteric Bursitis.

Is NCT04182672 still recruiting?

NCT04182672 is currently completed. Last updated 2 January 2024.

Are results published for NCT04182672?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-01-02 · How we verify

NCT04182672

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 2 Results posted Last updated 2 January 2024

What this trial tests

Phase 2 trial testing FX006 in Trochanteric Bursitis in 22 participants. Completed in 14 December 2022.

Timeline

12 August 2020

Primary endpoint
14 December 2022

14 December 2022

Quick facts

Lead sponsor	The University of Texas Health Science Center, Houston
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	22
Start date	12 August 2020
Primary completion	14 December 2022
Estimated completion	14 December 2022
Sites	1 location across United States

Drugs / interventions tested

FX006 — full drug profile →

Conditions studied

Trochanteric Bursitis — all drugs for Trochanteric Bursitis →

Sponsor

The University of Texas Health Science Center, Houston

Who can join

18 and older, any sex, with Trochanteric Bursitis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Pain From Baseline as Assessed by the Numeric Pain Rating Scale (NPRS) Score Primary · Baseline,week 12

Numeric Pain Rating Scale total score ranges from 0 (no pain) to 10 (most intense pain imaginable).

Group	Value	95% CI
FX006	-2.25	± 3.64

Patient Global Impression of Change (PGIC) Score Secondary · from start of treatment to week 12 of treatment

The PGIC is a 7 point scale ranging from very much improved (1) to very much worsened (7) 1. No change (or condition has got worse) 2. Almost the same, hardly any change at all 3. A little better, but no noticeable change 4. Somewhat better, but the change has not made any real difference 5. Moderately better, and a slight but noticeable change 6. Better, and a definite improvement that has made a real and worthwhile difference 7. A great deal better, and a considerable improvement that has made all the difference

Group	Value	95% CI
FX006	5	1 – 7

Adverse events — posted to ClinicalTrials.gov

Time frame: 12 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

FX006

Serious: 0/22 (0%)

Deaths: 0/22

Other adverse events (5 terms — click to expand)

Reaction	System	FX006
Pain at Injection Site	Musculoskeletal and connective tissue disorders	—
Hip Pain	Musculoskeletal and connective tissue disorders	—
Headache	Nervous system disorders	—
Fall	Nervous system disorders	—
Subcutaneous and Skin Disorders-other-lump at injection site	Musculoskeletal and connective tissue disorders	—

Data from ClinicalTrials.gov NCT04182672 adverse events section.

Sponsor's own description

The purpose of this study is to determine the safety and efficacy of FX006 in bursal injections and to assess the patient's impression to change in their chronic pain, following treatment.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of FX006

Trials testing the same drug.

NCT04160091 — Study to Evaluate the Efficacy and Safety of FX006 in Patients With Glenohumeral Osteoarthritis or Shoulder Adhesive Cap · Phase 2 · terminated
NCT03793010 — Study to Evaluate the Efficacy and Safety of FX006 in Patients With Hip Osteoarthritis · Phase 3 · terminated

Other The University of Texas Health Science Center, Houston trials

Trials by the same sponsor.

NCT04200729 — Povidone-iodine Irrigation for Prevention of Intra-abdominal Abscess in Pediatric Perforated Appendicitis: a Multi-cente · Phase 4 · not yet recruiting
NCT07225062 — Improving HIV Prevention and Substance Use Post-Sexual Assault Services · NA · not yet recruiting
NCT07396974 — Increasing Treatment Access in Trauma Exposed Children: Developing an Adapted Step One Intervention (RCT) · NA · not yet recruiting
NCT07170163 — Navigating the Transition to Adulthood: A Dual Language Mobile App for Latino Youth With ASD and Their Families · NA · not yet recruiting
NCT06915441 — Lipid Infusions to Optimize Nutrition Trial · Phase 2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04182672 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by The University of Texas Health Science Center, Houston
Last refreshed: 2 January 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04182672.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing