N/A
Completed N=368
Cingal Study for Knee Osteoarthritis
Source: ClinicalTrials.gov NCT01891396 ↗Enrolled (actual)
368
Serious AEs
1.4%
Results posted
May 2022
Primary outcomePrimary: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score Comparing Cingal® to Saline (ITT) — -40.2; -36.1; -31.0 score on a scale — p=0.0099
Summary
The purpose of this study is to see if a single injection of Cingal into the knee provides safe relief of pain caused by osteoarthritis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score Comparing Cingal® to Saline (ITT) |
-41.1; -31.4 | 0.0072 sig |
| PRIMARY Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score Comparing Cingal® to Saline (PP) |
-40.3; -35.9; -32.2 | 0.0029 sig |
| SECONDARY Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score Comparing Cingal® to Monovisc® (ITT) |
-40.1; -34.9 | 0.0289 sig |
| SECONDARY OMERACT-OARSI Responder Index Comparing Cingal® to Saline (ITT) |
92.0; 81.9 | 0.0141 sig |
| SECONDARY Patient Global Assessment (PGA) Comparing Cingal® to Saline (ITT) |
-37.0; -26.3 | 0.0005 sig |
| SECONDARY Patient Global Assessment (PGA) Comparing Cingal® to Monovisc® (ITT) |
-37.7; -32.1 | 0.0323 sig |
| SECONDARY Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score Comparing Cingal® to Saline (ITT) |
-41.1; -31.4 | 0.0072 sig |
| SECONDARY Evaluator Global Assessment Comparing Cingal® to Saline (ITT) |
-37.8; -28.7 | 0.0046 sig |
| SECONDARY Evaluator Global Assessment Comparing Cingal® to Monovisc® (ITT) |
-37.5; -32.6 | 0.0579 |
| SECONDARY Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score Comparing Cingal® to Monovisc® (PP) |
-41.3; -35.3 | 0.0154 sig |
| SECONDARY OMERACT-OARSI Responder Index Comparing Cingal® to Saline (PP) |
92.8; 83.6 | 0.0227 sig |
| SECONDARY Patient Global Assessment (PGA) Comparing Cingal® to Saline (PP) |
-38.6; -27.0 | 0.0005 sig |
| SECONDARY Patient Global Assessment (PGA) Comparing Cingal® to Monovisc® (PP) |
-39.2; -32.4 | 0.0113 sig |
| SECONDARY Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score Comparing Cingal® to Saline. (PP) |
-41.2; -32.4 | 0.0016 sig |
| SECONDARY Evaluator Global Assessment Comparing Cingal® to Saline (PP) |
-39.1; -29.8 | 0.0059 sig |
| SECONDARY Evaluator Global Assessment Comparing Cingal® and Monovisc® (PP). |
-32.9; -26.5 | 0.0095 sig |
| SECONDARY Evaluator Global Assessment Comparing Cingal® to Monovisc® (PP) |
-38.6; -32.0 | 0.0136 sig |
Eligibility Criteria
Inclusion Criteria
- Subject is 40 - 75 years old with a Body Mass Index (BMI)≤ 40 kg/m2
- Subject has Kellgren-Lawrence (K-L) severity grade I, II, or III in the index knee as determined by X-Ray. Contralateral knee: K-L severity grade 0, I, or II.
Exclusion Criteria
- Subject received an intra-articular (IA) injection of Hyaluronic Acid (HA) and/or steroid in either knee within 6 months of signing the informed consent form (ICF).
- Subject had an arthroscopy of either knee within 3 months of signing the informed consent form (ICF).
Data sourced from ClinicalTrials.gov (NCT01891396). 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.