Phase 3
Completed N=202
Gel-200 Extension and Open-Label Study in Osteoarthritis of the Knee
Source: ClinicalTrials.gov NCT00450112 ↗Enrolled (actual)
202
Serious AEs
2.0%
Results posted
Aug 2011
Primary outcomePrimary: Occurrence of Systemic and Local Adverse Events Following a Single or Repeat Intra-articular Injection of Gel-200 — 68; 43 participants — p=>0.1
Summary
The purpose of this study is to determine if a single or repeat intra-articular injection of Gel-200 is safe and effective in subjects with symptomatic osteoarthritis of the knee and to determine if original SI-6606/01 Gel-200 therapy is durable beyond the original study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Occurrence of Systemic and Local Adverse Events Following a Single or Repeat Intra-articular Injection of Gel-200 |
68; 43 | >0.1 |
| SECONDARY Improvement From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Visual Analog Scale (VAS) (Pain Subscore) |
32.3; 35.4 | <0.0001 sig |
| SECONDARY Improvement From Baseline in WOMAC VAS (Stiffness Subscore) |
29.0; 34.5 | <0.0001 sig |
| SECONDARY Improvement From Baseline in WOMAC VAS (Physical Function Subscore) |
30.1; 34.4 | <0.0001 sig |
| SECONDARY Improvement From Baseline in WOMAC VAS (Total Score) |
30.4; 34.6 | <0.0001 sig |
| SECONDARY Outcome Measures in Rheumatology Artthritis Clinical Trials (OMERACT) - and the Osteoarthritis Research Society International (OARSI) Response |
58.0; 57.7; 75.0; 77.5 | — |
| SECONDARY Improvement From Baseline in Subject Global Evaluations |
29.8; 33.4 | <0.0001 sig |
| SECONDARY Improvement From Baseline in Physician Global Evaluations |
27.4; 27.4 | <0.0001 sig |
| SECONDARY Acetaminophen Consumption |
1677.4; 1822.5 | — |
Eligibility Criteria
Inclusion Criteria
- Previous participation in study SI-6606/01.
Exclusion Criteria
- Female subjects who are pregnant or lactating.
Data sourced from ClinicalTrials.gov (NCT00450112). 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.