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Repeat Injection of Cingal® for Osteoarthritis of the Knee

Primary Purpose

Osteoarthritis of the Knee

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Cingal
Cingal
Cingal
Sponsored by
Anika Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis of the Knee focused on measuring Osteoarthritis, Intra-articular Injection, Hyaluronic Acid, Triamcinolone Hexacetonide

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Medical Plus s.r.o.
  • Belvaros-Lipotvaros, Orthopedic Outpatient Clinic
  • Semmelweis University, Department of Orthopaedics
  • Uzsoki Hospital, Department of Traumatology
  • Jutrix Healthcare Services Ltd.
  • Medidea Bt.
  • G&V Pharma-Med Bt.
  • NZOZ Medi-Spatz
  • ARTIMED Niepubliczny Zaklad Opieki Zdrowotnej w Kielcach
  • CenterMed Krakow Sp. z o.o.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Cingal/Cingal

Cingal/Monovisc

Cingal/Saline

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Number of Treatment-Emergent Adverse Events: Cingal 13-02 vs. Cingal 13-01
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.

Secondary Outcome Measures

Full Information

First Posted
March 3, 2015
Last Updated
February 23, 2022
Sponsor
Anika Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02381652
Brief Title
Repeat Injection of Cingal® for Osteoarthritis of the Knee
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 Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Anika Therapeutics, Inc.

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
The Cingal 13-02 study is a follow-on study to the recently completed clinical trial Cingal 13-01 [NCT01891396]. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis of the Knee
Keywords
Osteoarthritis, Intra-articular Injection, Hyaluronic Acid, Triamcinolone Hexacetonide

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
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.
Allocation
Non-Randomized
Enrollment
242 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cingal/Cingal
Arm Type
Experimental
Arm Description
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.
Arm Title
Cingal/Monovisc
Arm Type
Experimental
Arm Description
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.
Arm Title
Cingal/Saline
Arm Type
Experimental
Arm Description
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.
Intervention Type
Combination Product
Intervention Name(s)
Cingal
Other Intervention Name(s)
Hyaluronic Acid with Triamcinolone Hexacetonide
Intervention Description
Injection into the knee
Intervention Type
Combination Product
Intervention Name(s)
Cingal
Other Intervention Name(s)
Hyaluronic Acid with Triamcinolone Hexacetonide
Intervention Description
Injection into the knee
Intervention Type
Combination Product
Intervention Name(s)
Cingal
Other Intervention Name(s)
Hyaluronic Acid with Triamcinolone Hexacetonide
Intervention Description
Injection into the knee
Primary Outcome Measure Information:
Title
Number of Treatment-Emergent Adverse Events: Cingal 13-02 vs. Cingal 13-01
Description
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.
Time Frame
Baseline through 6 weeks post-injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject completed Cingal 13-01 and is interested in participating in the follow-on study Subject must be willing to abstain from other intra-articular or surgical treatments of the index knee for the duration of the study Subject is willing to discontinue all analgesics except acetaminophen/paracetamol for the duration of the study 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 Subject is able to understand and comply with the requirements of the study and voluntarily provides consent Exclusion Criteria: Subject received an intra-articular injection or underwent a surgical procedure of the index knee since the study injection in Cingal 13-01 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. 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. Subject has a contraindication to IA injections, aspiration of the index knee, corticosteroids, hyaluronan, or acetaminophen/paracetamol. Subject is pregnant or breastfeeding or a woman of child bearing potential who refuses to use effective contraception during the course of the study. Subject participated in a research study other than Cingal 13-01 within 60 days of consent.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laszlo Hangody, MD, PhD, DSc
Organizational Affiliation
Semmelweis University, Head of Department of Traumatology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Piotr Lukasik, MD, PhD
Organizational Affiliation
NZOZ Medi-Spatz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical Plus s.r.o.
City
Uherske Hradiste
Country
Czechia
Facility Name
Belvaros-Lipotvaros, Orthopedic Outpatient Clinic
City
Budapest
Country
Hungary
Facility Name
Semmelweis University, Department of Orthopaedics
City
Budapest
Country
Hungary
Facility Name
Uzsoki Hospital, Department of Traumatology
City
Budapest
Country
Hungary
Facility Name
Jutrix Healthcare Services Ltd.
City
Kecskemet
Country
Hungary
Facility Name
Medidea Bt.
City
Kiskunfelegyhaza
Country
Hungary
Facility Name
G&V Pharma-Med Bt.
City
Mako
Country
Hungary
Facility Name
NZOZ Medi-Spatz
City
Gliwice
Country
Poland
Facility Name
ARTIMED Niepubliczny Zaklad Opieki Zdrowotnej w Kielcach
City
Kielce
Country
Poland
Facility Name
CenterMed Krakow Sp. z o.o.
City
Krakow
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is not a plan to share individual participant data

Learn more about this trial

Repeat Injection of Cingal® for Osteoarthritis of the Knee

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