Study of Cingal for the Relief of Knee Osteoarthritis Compared to Triamcinolone Hexacetonide at 39 Weeks Follow up
NCT03390036 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 526
Last updated 2023-05-31
Summary
Extension study to Cingal 16-02 to obtain 39-week safety and efficacy follow-up data
Conditions
Interventions
- COMBINATION_PRODUCT
-
Cingal
Hyaluronic Acid with Triamcinolone Hexacetonide
- DEVICE
-
Monovisc
Hyaluronic Acid
- DRUG
-
Triamcinolone Hexacetonide
Triamcinolone Hexacetonide
Sponsors & Collaborators
-
Anika Therapeutics, Inc.
lead INDUSTRY
Principal Investigators
-
Laszlo Hangody, MD · Uzsoki Hospital, Department of Traumatology
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 40 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-12-07
- Primary Completion
- 2018-07-30
- Completion
- 2018-07-30
- FDA Drug
- Yes
- FDA Device
- Yes
Countries
- Hungary
- Poland
Study Locations
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