N/A
Completed N=349
Comparative Study of Safety and Efficacy of Two Hyaluronic Acids for the Treatment of Knee Osteoarthritis Pain
Source: ClinicalTrials.gov NCT01295580 ↗Enrolled (actual)
349
Serious AEs
2.6%
Results posted
Apr 2021
Primary outcomePrimary: WOMAC (Western Ontario and McMaster Osteoarthritis Index) Pain Subscale Change From Baseline — -5.87; -5.97 units on a scale
Summary
The purpose of this study is to determine the comparative safety and efficacy of intra-articular injection of hyaluronic acid, obtained from two different sources, in the treatment of osteoarthritic pain of the knee.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY WOMAC (Western Ontario and McMaster Osteoarthritis Index) Pain Subscale Change From Baseline |
-6.05; -6.15 | — |
| SECONDARY WOMAC (Western Ontario and McMaster Osteoarthritis Index) Pain Subscale Change From Baseline |
-6.05; -6.15 | — |
| SECONDARY WOMAC (Western Ontario and McMaster Osteoarthritis Index) Physical Function Subscale Change From Baseline |
-12.58; -13.16 | — |
| SECONDARY Subject Global Assessment Change From Baseline |
2.67; 2.81 | — |
| SECONDARY WOMAC (Western Ontario and McMaster Osteoarthritis Index) Knee Stiffness Subscale Change From Baseline |
-1.80; -1.95 | — |
Eligibility Criteria
Inclusion Criteria
- Subject (female or male) 40-80 years of age, inclusive
- Documented diagnosis of mild to moderate osteoarthritis of the study knee that fulfil the ACR(American College of Rheumatology) criteria
- Radiographic evidence of osteoarthritis in the study knee (Kellgren Lawrence radiographic score is 2 or 3)
Exclusion Criteria
- Clinically apparent tense effusion of the study knee on examination determined by either a positive bulge sign or positive ballottement of the patella
- Kellgren-Lawrence radiographic score 0, 1 or 4 in the study knee
- Symptomatic osteoarthritis of the contralateral knee or of either hip that is not responsive to acetaminophen/paracetamol and/or requires any protocol prohibited therapies
Data sourced from ClinicalTrials.gov (NCT01295580). 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.