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
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, see Learn About Clinical Studies.

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
Viscosupplements
Protective Agents
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 August 28, 2014