Cingal Study for Knee Osteoarthritis

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Anika Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01891396
First received: June 28, 2013
Last updated: March 3, 2014
Last verified: March 2014
  Purpose

The purpose of this study is to see if a single injection of Cingal into the knee provides safe relief of pain caused by osteoarthritis.


Condition Intervention
Knee Osteoarthritis
Device: Hyaluronic Acid and TH
Device: Hyaluronic Acid
Device: Saline

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo 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

Resource links provided by NLM:


Further study details as provided by Anika Therapeutics, Inc.:

Primary Outcome Measures:
  • Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
    Change from baseline in the WOMAC pain score.


Estimated Enrollment: 368
Study Start Date: June 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Saline
Single injection of 0.9% saline supplied as a 4 mL unit dose in a 5mL glass syringe
Device: Saline
Saline placebo packaged to look identical to comparator syringes.
Experimental: Hyaluronic Acid and TH
Single injection of sodium hyaluronate with triamcinolone hexacetonide (TH) supplied as a 4 mL unit dose in a 5 mL glass syringe
Device: Hyaluronic Acid and TH
Other Name: Cingal
Active Comparator: Hyaluronic Acid
Single injection of sodium hyaluronate supplied as a 4 mL unit dose in a 5 mL glass syringe
Device: Hyaluronic Acid
Other Name: Monovisc

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject is 40 - 75 years old with a Body Mass Index (BMI)≤ 40 kg/m2
  • Subject has Kellgren-Lawrence(K-L)severity grade I, II, or III in the index knee as determined by X-Ray. Contralateral knee: K-L severity grade 0, I, or II.

Exclusion Criteria:

  • Subject received an IA injection of Hyaluronic Acid (HA) and/or steroid in either knee within 6 months of signing the ICF.
  • Subject had an arthroscopy of either knee within 3 months of signing the ICF.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01891396

Locations
Canada, Ontario
Deakon Medicine Professional Corporation
Oakville, Ontario, Canada, L6K 3T7
Sponsors and Collaborators
Anika Therapeutics, Inc.
Investigators
Principal Investigator: Laszlo Hangody, MD Uzsoki Hospital
  More Information

No publications provided

Responsible Party: Anika Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01891396     History of Changes
Other Study ID Numbers: Cingal 13-01
Study First Received: June 28, 2013
Last Updated: March 3, 2014
Health Authority: Canada: Health Canada
Bulgaria: Bulgarian Drug Agency
Czech Republic: State Institute for Drug Control
Hungary: Scientific and Medical Research Council Ethics Committee
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Keywords provided by Anika Therapeutics, Inc.:
Knee osteoarthritis
Hyaluronic acid
HA Injection
Steroid Injection
Knee injection

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Hyaluronic Acid
Triamcinolone Acetonide
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone diacetate
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunosuppressive Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014