CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 208 enrolled
Drug / intervention
FX006 32 mgdrug
Likely dose
FX006 32 mg intra-articular injectionAI-extracted
Key inclusion· 8
  • ✓Age ≥40 years
  • ✓Symptomatic knee OA for ≥6 months before screening
  • ✓Meets American College of Rheumatology (ACR) criteria for OA (clinical and radiological)
  • ✓Kellgren-Lawrence Grade 2, 3, or 4 on baseline X-ray
Key exclusion· 7
  • ✕Reactive arthritis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or arthritis associated with inflammatory bowel disease
  • ✕History of infection in the index knee joint
  • ✕Clinical signs/symptoms of active knee infection or crystal disease within 1 month of screening
  • ✕Surgical hardware or foreign body in the index knee

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

Search/NCT03046446
NCT03046446Phase 3Completed
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An Open-label Study to Assess the Safety of Repeat Administration of FX006 to Patients With Osteoarthritis of the Knee

Pacira Pharmaceuticals, Inc·interventional·Posted Feb 8, 2017·Updated Jan 24, 2024

In Brief

A Phase 3 clinical trial evaluating FX006 32 mg for Osteoarthritis of the Knee. Completed, enrolled 208 participants across 17 sites.

Detailed Summary

This is an Open-label Study to Assess the Safety of Repeat Dose of FX006 Administered to Patients with Osteoarthritis (OA) of the Knee

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoarthritis of the Knee
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedFeb 8, 2017
Enrollment StartFeb 20, 2017
Primary CompletionJul 19, 2018
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 9.4 years ago

Interventions

FX006 32 mgdrug

Single intra-articular injection