Phase 3
N=526
Study of Cingal for the Relief of Knee Osteoarthritis Compared to Triamcinolone Hexacetonide at 39 Weeks Follow up
Knee Osteoarthritis
Bottom Line
View on ClinicalTrials.gov: NCT03390036 ↗Enrolled (actual)
526
Serious AEs
0.0%
Results posted
May 2023
Primary outcome: Primary: OMERACT-OARSI Responder Rate at 39 Weeks — 91.2; 92.4; 93.2 Percentage of subjects — p=0.8106
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Cingal (Combination_product); Monovisc (Device); Triamcinolone Hexacetonide (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Anika Therapeutics, Inc.
- Primary completion
- Jul 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY OMERACT-OARSI Responder Rate at 39 Weeks |
91.2; 92.4; 93.2 | 0.8106 |
| SECONDARY Change From Baseline in WOMAC Pain Score at 39 Weeks |
-46.3; -47.2; -43.6; 63.3; 63.3; 63.8 | 0.3007 |
| SECONDARY Change From Baseline in WOMAC Physical Function Score at 39 Weeks |
-42.5; -43.5; -41.1; 60.8; 60.8; 61.8 | 0.6354 |
| SECONDARY Change From Baseline in WOMAC Stiffness Score at 39 Weeks |
-39.8; -42.0; -38.0; 57.7; 59.2; 57.9 | 0.5754 |
| SECONDARY Change From Baseline in Total WOMAC Score at 39 Weeks |
-128.4; -132.6; -122.7; 181.8; 183.4; 183.5 | 0.4759 |
| SECONDARY Change From Baseline in Patient Global Assessment at 39 Weeks |
-38.6; -38.2; -36.7; 57.0; 56.0; 58.2 | 0.5596 |
| SECONDARY Change From Baseline in Evaluator Global Assessment at 39 Weeks |
-37.1; -37.7; -39.1; 52.9; 52.3; 56.6 | 0.4551 |
| SECONDARY The Usage of Rescue Medication (Acetaminophen) at Week 39 |
7.9; 6.0; 6.9 | 0.7931 |
Summary
Extension study to Cingal 16-02 to obtain 39-week safety and efficacy follow-up data
Eligibility Criteria
Inclusion Criteria
- Only subjects that were enrolled and met the inclusion criteria for the Cingal 16-02 trial and signed the informed consent are eligible for Cingal 17-02 trial.
- Subject is able to understand and comply with the requirements of Cingal 17-02 and voluntarily provides consent.
Exclusion Criteria
Patients will not be rescreened at enrollment to Cingal 17-02 as these patients met the inclusion / exclusion criteria for the Cingal 16-02 clinical trial.
Data sourced from ClinicalTrials.gov (NCT03390036). 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.