Phase 3
Completed N=379
Gel-200 Versus Placebo in Osteoarthritis of the Knee
Source: ClinicalTrials.gov NCT00449696 ↗Enrolled (actual)
379
Serious AEs
2.1%
Results posted
Sep 2011
Primary outcomePrimary: Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Visual Analog Scale (VAS) Pain Subscore — 27.8; 22.6 scores on a scale — p=0.037
Summary
The purpose of this study is to determine if a single intra-articular injection of Gel-200 is superior to a single injection of Phosphate Buffered Saline (PBS) in subjects with symptomatic osteoarthritis of the knee.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Visual Analog Scale (VAS) Pain Subscore |
27.8; 22.6 | 0.037 sig |
| SECONDARY Change From Baseline in WOMAC VAS Stiffness Subscore |
26.9; 22.5 | 0.122 |
| SECONDARY Change From Baseline in WOMAC VAS Physical Function Subscore |
26.2; 21.0 | 0.071 |
| SECONDARY Change From Baseline in WOMAC VAS Total Score |
26.6; 21.5 | 0.058 |
| SECONDARY Outcome Measures in Rheumatology Arthritis Clinical Trials (OMERACT)- and the Osteoarthritis Research Society International (OARSI) Response |
45.9; 38.7; 61.0; 54.6 | 0.022 sig |
| SECONDARY Change From Baseline in Short Form - 36 (SF-36) |
4.6; 5.3 | >0.05 |
| SECONDARY Change From Baseline in Subject Global Evaluations |
22.8; 22.0 | 0.746 |
| SECONDARY Change From Baseline in Physician Global Evaluations |
21.3; 19.0 | 0.166 |
| SECONDARY Acetaminophen Consumption |
2007; 2599 | 0.041 sig |
Eligibility Criteria
Inclusion Criteria
- Subjects with a diagnosis of painful, symptomatic tibio-femoral osteoarthritis of the knee (Grade 1-3 on Kellgren - Lawrence (K-L) score).
Exclusion Criteria
- Subjects with Grade 4 on K-L score
- Subjects with inflammatory diseases of the knee other than osteoarthritis such as rheumatoid arthritis
- Serious systemic diseases
- Female subjects who are pregnant or lactating
Data sourced from ClinicalTrials.gov (NCT00449696). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.