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Repeat Injection of Cingal® for Osteoarthritis of the Knee

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: NCT02381652
Recruitment Status : Completed
First Posted : March 6, 2015
Results First Posted : September 3, 2020
Last Update Posted : September 3, 2020
Sponsor:
Information provided by (Responsible Party):
Anika Therapeutics, Inc.

Brief Summary:
The objective of this study is to evaluate the safety of an injection of Cingal® in subjects with Osteoarthritis (OA) of the knee who participated in Cingal 13-01, and who received either a Cingal, Monovisc, or saline injection in the 13-01 study. The safety evaluation will be done by a through examination of the incidence of adverse events and physical examination of the knee.

Condition or disease Intervention/treatment Phase
Osteoarthritis of the Knee Combination Product: Cingal Phase 3

Detailed Description:
The Cingal 13-02 study is a follow-on study to the recently completed clinical trial Cingal 13-01. Cingal 13-01 was a multi-center, randomized, double-blind, Phase III study that enrolled 368 subjects at up to 20 sites in Canada and Europe. The Cingal 13-01 study objective was to assess the safety and effectiveness of a single injection of Cingal® for relief of joint pain and symptoms in patients with osteoarthritis (OA) of the knee. The study had three arms: the Cingal® investigational arm, an active comparator arm (Monovisc®) and a control arm (saline). Cingal 13-02 is designed to evaluate the safety of an open-label injection of Cingal® in subjects who received a study injection in the Cingal 13-01 trial. Sites that enrolled 5 or more subjects in the Cingal 13-01 study were eligible to participate in the Cingal 13-02 study. All subjects at these sites who met enrollment criteria had the option to participate in the follow-on study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 242 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: All subjects enrolled into the Cingal 3-02 follow-on study received an intra-articular injection of Cingal. The three 'arms' of the study were for subjects who received a Cingal, Monovisc, or saline initial injection in the Cingal 13-01 study.
Masking: None (Open Label)
Masking Description: Cingal 13-02 was an open label follow-up study. The participants, investigators and outcomes assessors were blinded to the specific study injection subjects had previously received in Cingal 13-01.
Primary Purpose: Treatment
Official Title: An Open-Label, Follow-On Study to Cingal 13-01 to Evaluate the Safety of a Repeat Injection of Cross-Linked Sodium Hyaluronate Combined With Triamcinolone Hexacetonide to Provide Symptomatic Relief of Osteoarthritis of the Knee
Study Start Date : February 2015
Actual Primary Completion Date : April 2015
Actual Study Completion Date : May 2015


Arm Intervention/treatment
Experimental: Cingal/Cingal
Subjects who had received an injection of Cingal in the 13-01 study will receive a single 4 milliliter (mL) intra-articular injection of Cingal (88 milligrams Hyaluronic Acid plus 18 milligramsTriamcinolone Hexacetonide) in the index knee in the 13-02 study.
Combination Product: Cingal
Injection into the knee
Other Name: Hyaluronic Acid with Triamcinolone Hexacetonide

Experimental: Cingal/Monovisc
Subjects who had received an injection of Monovisc in the 13-01 study will receive a single 4 milliliter (mL) intra-articular injection of Cingal (88 milligrams Hyaluronic Acid plus 18 milligramsTriamcinolone Hexacetonide) in the index knee in the 13-02 study.
Combination Product: Cingal
Injection into the knee
Other Name: Hyaluronic Acid with Triamcinolone Hexacetonide

Experimental: Cingal/Saline
Subjects who had received an injection of Saline in the 13-01 study will receive a single 4 milliliter (mL) intra-articular injection of Cingal (88 milligrams Hyaluronic Acid plus 18 milligramsTriamcinolone Hexacetonide) in the index knee in the 13-02 study.
Combination Product: Cingal
Injection into the knee
Other Name: Hyaluronic Acid with Triamcinolone Hexacetonide




Primary Outcome Measures :
  1. Safety Comparison of Adverse Event Profile of Cingal 13-02 vs. Cingal 13-01 [ Time Frame: Baseline through 6 weeks post-injection ]
    The primary outcome measure will compare safety results (all adverse events, whether related to the study injection or not) for Cingal 13-01 and Cingal 13-02.



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
Criteria

Inclusion Criteria:

  1. Subject completed Cingal 13-01 and is interested in participating in the follow-on study
  2. Subject must be willing to abstain from other intra-articular or surgical treatments of the index knee for the duration of the study
  3. Subject is willing to discontinue all analgesics except acetaminophen/paracetamol for the duration of the study
  4. Subject is willing to use only acetaminophen/paracetamol (up to a maximum of 4.0 grams per day per the package insert) for the treatment of joint pain for the duration of the study. At least twenty-four hours prior to the injection and each follow-up visit, the subject is willing to discontinue use of acetaminophen/paracetamol
  5. Subject is able to understand and comply with the requirements of the study and voluntarily provides consent

Exclusion Criteria:

  1. Subject received an intra-articular injection or underwent a surgical procedure of the index knee since the study injection in Cingal 13-01
  2. Subject is taking medication at the time of consent which could interfere with the treatment procedure, healing and/or assessments. This includes but is not limited to oral or injectable anticoagulant treatments, anti-aggregant platelet treatment and opioid analgesics. Low dose aspirin used for cardiovascular protection is allowed if a stable regimen is maintained for the duration of the study.
  3. Subjects who had an oral, intramuscular, intravenous, rectal suppository or topical (excluded in index knee only) corticosteroid within 30 days of signing the ICF are excluded. Topical corticosteroid use at any site other than the index knee is allowed.
  4. Subject has a contraindication to IA injections, aspiration of the index knee, corticosteroids, hyaluronan, or acetaminophen/paracetamol.
  5. Subject is pregnant or breastfeeding or a woman of child bearing potential who refuses to use effective contraception during the course of the study.
  6. Subject participated in a research study other than Cingal 13-01 within 60 days of consent.

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): NCT02381652


Locations
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Czechia
Medical Plus s.r.o.
Uherske Hradiste, Czechia
Hungary
Belvaros-Lipotvaros, Orthopedic Outpatient Clinic
Budapest, Hungary
Semmelweis University, Department of Orthopaedics
Budapest, Hungary
Uzsoki Hospital, Department of Traumatology
Budapest, Hungary
Jutrix Healthcare Services Ltd.
Kecskemet, Hungary
Medidea Bt.
Kiskunfelegyhaza, Hungary
G&V Pharma-Med Bt.
Mako, Hungary
Poland
NZOZ Medi-Spatz
Gliwice, Poland
ARTIMED Niepubliczny Zaklad Opieki Zdrowotnej w Kielcach
Kielce, Poland
CenterMed Krakow Sp. z o.o.
Krakow, Poland
Sponsors and Collaborators
Anika Therapeutics, Inc.
Investigators
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Principal Investigator: Laszlo Hangody, MD, PhD, DSc Semmelweis University, Head of Department of Traumatology
Principal Investigator: Piotr Lukasik, MD, PhD NZOZ Medi-Spatz
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Responsible Party: Anika Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02381652    
Other Study ID Numbers: Cingal 13-02
First Posted: March 6, 2015    Key Record Dates
Results First Posted: September 3, 2020
Last Update Posted: September 3, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is not a plan to share individual participant data

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Anika Therapeutics, Inc.:
Osteoarthritis
Intra-articular Injection
Hyaluronic Acid
Triamcinolone Hexacetonide
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
Hyaluronic Acid
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
Adjuvants, Immunologic
Viscosupplements
Protective Agents