Trial Extension to 39 Week Follow Up in the Randomized, Blinded Trial to compare a Single Injection of Cingal® (Cross-Linked Sodium Hyaluronate Combined with Triamcinolone Hexacetonide) with Cross-Linked Sodium Hyaluronate alone and with Triamcinolone Hexacetonide alone for Providing Symptomatic Relief of Osteoarthritis of the Knee

Phase 1

• Conditions: Osteoarthritis of the Knee; MedDRA version: 20.0Level: LLTClassification code 10031165Term: Osteoarthritis kneeSystem Organ Class: 100000004859; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2017-003205-18-PL
• Lead Sponsor: Anika Therapeutics, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-11-09
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 576

Inclusion Criteria

1. Subjects meet the inclusion criteria for Cingal 16-02 and signed the informed consent.
2. Subject is able to understand and comply with the requirements of Cingal 17-02 and voluntarily provides consent.

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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 519
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 57

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.

All patients enrolled in the Cingal 16-02 trial will be eligible to participate in Cingal 17-02.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified