Status:
COMPLETED
Study of Cingal for the Relief of Knee Osteoarthritis Compared to Triamcinolone Hexacetonide at 39 Weeks Follow up
Lead Sponsor:
Anika Therapeutics, Inc.
Conditions:
Knee Osteoarthritis
Eligibility:
All Genders
40-75 years
Phase:
PHASE3
Brief Summary
Extension study to Cingal 16-02 to obtain 39-week safety and efficacy follow-up data
Detailed Description
Extension Study to Cingal 16-02: Trial Extension to 39 Week Follow Up in the Randomized, Double-Blind, Active Comparator Controlled, Multi-Center Study of a Single Injection Cross-Linked Sodium Hyalur...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 7 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 30 2018
Estimated Enrollment :
526 Patients enrolled
Trial Details
Trial ID
NCT03390036
Start Date
December 7 2017
End Date
July 30 2018
Last Update
May 31 2023
Active Locations (17)
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1
Health Center of Downtown-Lipotvaros, Orthopedic Outpatient Clinic (Belvárosi-Lipótvárosi Egészségügyi Szolgálat Ortopeadia)
Budapest, Hungary, 1051
2
Uzsoki Hospital, Department of Traumatology
Budapest, Hungary, 1145
3
Jutrix Medical Llc
Budapest, Hungary, 6000
4
Magyar Honvedseg, Egeszseugyi Kozpont, Balesteti Sebeszeti Osztaly
Budapest, Hungary