Study of Cingal™ for the Relief of Knee Osteoarthritis Compared to Triamcinolone Hexacetonide at 39 Weeks Follow up

• Status: Completed
• Trial end date: 2018-07-30
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this sub-study is to evaluate the efficacy and safety at 39 week follow up of a single injection of Cingal for relief of joint pain in subjects with OA of the knee who have not responded to conservative treatment (weight reduction, physical therapy, pain medications, etc.).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Anika Therapeutics, Inc.
• Treatments: Triamcinolone; Triamcinolone Acetonide; Triamcinolone diacetate; Triamcinolone hexacetonide

Criteria

Inclusion Criteria:

1. 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.

2. 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.