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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.

Tracking Information
First Submitted Date  ICMJE December 28, 2017
First Posted Date  ICMJE January 4, 2018
Last Update Posted Date September 18, 2018
Actual Study Start Date  ICMJE December 7, 2017
Actual Primary Completion Date July 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 28, 2017)
OMERACT-OARSI Responder Rate [ Time Frame: 39 weeks ]
Outcomes Measures for Rheumatic Arthritis Clinical Trials-Osteoarthritis Research Society International
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Cingal™ for the Relief of Knee Osteoarthritis Compared to Triamcinolone Hexacetonide at 39 Weeks Follow up
Official Title  ICMJE 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
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.).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Osteo Arthritis Knee
Intervention  ICMJE
  • Drug: Cingal
    A chemically cross-linked sodium hyaluronate supplied as a 4-mL unit dose with a nominal 18 mg of triamcinolone hexacetonide (TH)
  • Device: Monovisc
    A chemically cross-linked sodium hyaluronate supplied as a 4-mL unit dose
  • Drug: Triamcinolone Hexacetonide
    20 mg/ml supplied as 1 mL unit dose of Triamcinolone Hexacetonide
    Other Name: TH
Study Arms  ICMJE
  • Experimental: Cingal
    A chemically cross-linked sodium hyaluronate supplied as a 4-mL unit dose with a nominal 18 mg of triamcinolone hexacetonide (TH).
    Intervention: Drug: Cingal
  • Active Comparator: Monovisc
    A chemically cross-linked sodium hyaluronate supplied as a 4-mL unit dose
    Intervention: Device: Monovisc
  • Active Comparator: Triamcinolone Hexacetonide (TH)
    A 1 mL unit dose of Triamcinolone Hexacetonide (TH) supplied as 20 mg/ml.
    Intervention: Drug: Triamcinolone Hexacetonide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 14, 2018)
526
Original Estimated Enrollment  ICMJE
 (submitted: December 28, 2017)
576
Actual Study Completion Date  ICMJE July 30, 2018
Actual Primary Completion Date July 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Hungary,   Poland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03390036
Other Study ID Numbers  ICMJE Cingal 17-02
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Anika Therapeutics, Inc.
Study Sponsor  ICMJE Anika Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Laszlo Hangody, MD Uzsoki Hospital, Department of Traumatology
PRS Account Anika Therapeutics, Inc.
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP