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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03390036
Recruitment Status : Completed
First Posted : January 4, 2018
Last Update Posted : September 18, 2018
Sponsor:
Information provided by (Responsible Party):
Anika Therapeutics, Inc.

Brief 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.).

Condition or disease Intervention/treatment Phase
Osteo Arthritis Knee Drug: Cingal Device: Monovisc Drug: Triamcinolone Hexacetonide Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 526 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : December 7, 2017
Actual Primary Completion Date : July 30, 2018
Actual Study Completion Date : July 30, 2018


Arm Intervention/treatment
Experimental: Cingal
A chemically cross-linked sodium hyaluronate supplied as a 4-mL unit dose with a nominal 18 mg of triamcinolone hexacetonide (TH).
Drug: Cingal
A chemically cross-linked sodium hyaluronate supplied as a 4-mL unit dose with a nominal 18 mg of triamcinolone hexacetonide (TH)

Active Comparator: Monovisc
A chemically cross-linked sodium hyaluronate supplied as a 4-mL unit dose
Device: Monovisc
A chemically cross-linked sodium hyaluronate supplied as a 4-mL unit dose

Active Comparator: Triamcinolone Hexacetonide (TH)
A 1 mL unit dose of Triamcinolone Hexacetonide (TH) supplied as 20 mg/ml.
Drug: Triamcinolone Hexacetonide
20 mg/ml supplied as 1 mL unit dose of Triamcinolone Hexacetonide
Other Name: TH




Primary Outcome Measures :
  1. OMERACT-OARSI Responder Rate [ Time Frame: 39 weeks ]
    Outcomes Measures for Rheumatic Arthritis Clinical Trials-Osteoarthritis Research Society International



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03390036


Locations
Show Show 17 study locations
Sponsors and Collaborators
Anika Therapeutics, Inc.
Investigators
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Principal Investigator: Laszlo Hangody, MD Uzsoki Hospital, Department of Traumatology
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Responsible Party: Anika Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03390036    
Other Study ID Numbers: Cingal 17-02
First Posted: January 4, 2018    Key Record Dates
Last Update Posted: September 18, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
Triamcinolone diacetate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action