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

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 - not available

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-003205-18-PL

Enrollment

576

Registered

2017-11-09

Start date

2018-01-26

Completion date

Unknown

Last updated

2019-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis of the Knee MedDRA version: 20.0 Level: LLT Classification code 10031165 Term: Osteoarthritis knee System Organ Class: 100000004859

Interventions

Pharmaceutical Form:

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the efficacy and safety of a single injection of Cingal for relief of joint pain at 39 week follow up in subjects with Osteoarthritis (OA) of the knee who have not responded to conservative treatment.;Secondary Objective: N/A;Primary end point(s): • The responder rate as identified by the Outcomes Measures for Rheumatic Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) responder index at 39 weeks post treatment comparing the Cingal group to the TH group.;Timepoint(s) of evaluation of this end point: 39 weeks post treatment	—

Measure

Time frame

Main Objective: To evaluate the efficacy and safety of a single injection of Cingal for relief of joint pain at 39 week follow up in subjects with Osteoarthritis (OA) of the knee who have not responded to conservative treatment.;Secondary Objective: N/A;Primary end point(s): • The responder rate as identified by the Outcomes Measures for Rheumatic Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) responder index at 39 weeks post treatment comparing the Cingal group to the TH group.;Timepoint(s) of evaluation of this end point: 39 weeks post treatment

—

Secondary

Measure	Time frame
Secondary end point(s): • The change from baseline in knee pain as measured by the WOMAC Pain Score (100 mm VAS) at 39 weeks post treatment comparing the Cingal group to the TH group. • The change from baseline in the Patient Global Assessment 39 weeks post treatment in the Cingal group compared to the TH group. • The change from baseline in the Evaluator Global Assessment at 39 weeks post treatment in the Cingal group compared to the TH group. ;Timepoint(s) of evaluation of this end point: 39 weeks post treatment	—

Measure

Time frame

Secondary end point(s): • The change from baseline in knee pain as measured by the WOMAC Pain Score (100 mm VAS) at 39 weeks post treatment comparing the Cingal group to the TH group. • The change from baseline in the Patient Global Assessment 39 weeks post treatment in the Cingal group compared to the TH group. • The change from baseline in the Evaluator Global Assessment at 39 weeks post treatment in the Cingal group compared to the TH group. ;Timepoint(s) of evaluation of this end point: 39 weeks post treatment

—

Countries

Poland

Contacts

Public ContactDirector of Clinical Affairs

Anika Therapeutics, Inc.

AOrr@AnikaTherapeutics.com+1781 457 9226

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026