CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 55 enrolled
Drug / intervention
FX006 32 mg +1 moredrug
Likely dose
FX006 32 mg intra-articular injection or TAcs 40 mg intra-articular injectionAI-extracted
Key inclusion· 7
  • ✓Age ≥40 years, male or female
  • ✓Osteoarthritis symptoms in index joint for ≥6 months
  • ✓Pain in index joint >15 days over last month
  • ✓For shoulder OA: radiologic findings meeting Samilson-Prieto Classification Grades 2 or 3
Key exclusion· 9
  • ✕Inflammatory arthritis (rheumatoid, psoriatic, ankylosing spondylitis, reactive, inflammatory bowel disease-associated)
  • ✕History of infection in index joint
  • ✕Active infection or crystal disease in index joint within 1 month of screening
  • ✕Fracture in index limb within 12 months or fracture with sequelae at any time

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03382262
NCT03382262Phase 2Completed
CompareCT.gov

A Randomized, Open-label Study Comparing the Systemic Exposure to Triamcinolone Acetonide Following a Single Intra-articular Dose of Extended-release FX006 or Immediate-release TAcs (Triamcinolone Acetonide Suspension) in Patients With Osteoarthritis of the Shoulder (Glenohumeral Joint) or Hip

Pacira Pharmaceuticals, Inc·interventional·Posted Dec 22, 2017·Updated Jan 24, 2024

In Brief

A Phase 2 clinical trial evaluating FX006 32 mg and TAcs 40 mg for Osteoarthritis of the Shoulder and Osteoarthritis of the Hip. Completed, enrolled 55 participants across 6 sites.

Detailed Summary

This is an open-label study to compare systemic exposure to triamcinolone acetonide following a dose of extended-release FX006 or immediate-release TAcs (triamcinolone acetonide suspension) in patients with osteoarthritis of the shoulder (glenohumeral joint) or hip

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoarthritis of the Shoulder, Osteoarthritis of the Hip
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedDec 22, 2017
Enrollment StartDec 18, 2017
Primary CompletionOct 9, 2018
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 8.5 years ago

Interventions

FX006 32 mgdrug

Extended-release 32 mg FX006 IA injection

TAcs 40 mgdrug

Immediate-release 40mg TAcs IA injection