Cingal Study for Knee Osteoarthritis

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. Identifier: NCT01891396
Recruitment Status : Completed
First Posted : July 3, 2013
Last Update Posted : December 31, 2014
Information provided by (Responsible Party):
Anika Therapeutics, Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Knee Osteoarthritis Device: Hyaluronic Acid and TH Device: Hyaluronic Acid Device: Saline Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 368 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : June 2013
Actual Primary Completion Date : May 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score [ Time Frame: 12 Weeks ]
    Change from baseline in the WOMAC pain score.

Information from the National Library of Medicine

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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

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.

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 identifier (NCT number): NCT01891396

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

Responsible Party: Anika Therapeutics, Inc. Identifier: NCT01891396     History of Changes
Other Study ID Numbers: Cingal 13-01
First Posted: July 3, 2013    Key Record Dates
Last Update Posted: December 31, 2014
Last Verified: December 2014

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

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