Study of Cingal for the Relief of Knee Osteoarthritis Compared to Triamcinolone Hexacetonide at 39 Weeks Follow up (Cingal17-02)

Anika Therapeutics

Status and phase: Completed; Phase 3

Conditions: Knee Osteoarthritis

Treatments: Drug: Triamcinolone Hexacetonide; Device: Monovisc; Combination Product: Cingal

Study type: Interventional

Funder types: Industry

Identifiers

NCT03390036

Cingal 17-02

Details and patient eligibility

About

Extension study to Cingal 16-02 to obtain 39-week safety and efficacy follow-up data

Full 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 Hyaluronate Combined with Triamcinolone Hexacetonide (Cingal) to Provide Symptomatic Relief of Osteoarthritis of the Knee

Enrollment: 526 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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526 participants in 3 patient groups

Cingal

Experimental group

Description:

Cingal is a combination product consisting of 88 milligrams of crosslinked HA (hyaluronic acid) with 18 milligrams of TH (triamcinolone hexacetonide) in a 4 milliliter (mL) intra-articular injection.

Treatment:

Combination Product: Cingal

Monovisc

Active Comparator group

Description:

Monovisc is a device that consists of 88 milligrams of cross-linked HA (hyaluronic acid) in a 4 milliliter (mL) intra-articular injection.

Treatment:

Device: Monovisc

Triamcinolone Hexacetonide (TH)

Active Comparator group

Description:

Triamcinolone hexacetonide (TH) is a corticosteroid supplied in a 20 milligram per 1 milliliter (20 mg/mL) intra-articular injection.

Treatment:

Drug: Triamcinolone Hexacetonide