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NCT04065074

Study to Evaluate a Procedure for Intra-articular Injection of FX006 in Patients With Osteoarthritis of the Hip

Completed Phase 2 Results posted Last updated 24 January 2024
What this trial tests

Phase 2 trial testing FX006 32 mg in Osteoarthritis, Hip in 16 participants. Completed in 30 December 2019.

Timeline
30 July 2019
Primary endpoint
11 October 2019
30 December 2019

Quick facts

Lead sponsorPacira Pharmaceuticals, Inc
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposeother
Enrollment16
Start date30 July 2019
Primary completion11 October 2019
Estimated completion30 December 2019
Sites5 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Pacira Pharmaceuticals, Inc — full company profile →

Who can join

Adults 40 to 80, any sex, with Osteoarthritis, Hip. 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.

Number of Patients With Successful Study Drug Administrations Primary · Day 1

Successful study drug administration, defined as Injector reporting complete study drug administration.

GroupValue95% CI
FX006 32 mg12

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse event data was collected from signing of informed consent to Last Visit.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

FX006 32 mg
Serious: 1/16 (6%)
Deaths: 0/16

Serious adverse events (1 terms)

ReactionSystemFX006 32 mg
Subchondrial Insufficiency FractureMusculoskeletal and connective tissue disorders

Most-reported serious reactions: Subchondrial Insufficiency Fracture.

Data from ClinicalTrials.gov NCT04065074 adverse events section.

Sponsor's own description

This is a multi-center, single-arm, open-label study of FX006 in patients with hip OA. A maximum number of approximately 30 patients may be enrolled in this protocol. All enrolled patients will receive a single intra-articular (IA) injection of FX006.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Recent Advances in Clinical Translation of Intra-Articular Osteoarthritis Drug Delivery Systems.
    DeJulius CR, Gulati S, Hasty KA, Crofford LJ, et al · · 2021 · cited 30× · PMID 33709019 · DOI 10.1002/adtp.202000088
  2. Challenges and opportunities of pharmacological interventions for osteoarthritis: A review of current clinical trials and developments.
    Vrouwe JPM, Burggraaf J, Kloppenburg M, Stuurman FE. · · 2021 · cited 16× · PMID 36474768 · DOI 10.1016/j.ocarto.2021.100212

Verify or expand the search:

Other trials of FX006 32 mg

Trials testing the same drug.

Other recruiting trials for Osteoarthritis, Hip

Currently open trials in the same condition.

Other Pacira Pharmaceuticals, Inc trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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/NCT04065074.

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