Repeat Injection of Cingal® for Osteoarthritis of the Knee

NCT ID: NCT02381652

Last Updated: 2022-03-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 242 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2015-05-31

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.

Conditions

Osteoarthritis of the Knee

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Cingal

Intervention Type: COMBINATION_PRODUCT

Injection into the knee

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.

Group Type: EXPERIMENTAL

Cingal

Intervention Type: COMBINATION_PRODUCT

Injection into the knee

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.

Group Type: EXPERIMENTAL

Cingal

Intervention Type: COMBINATION_PRODUCT

Injection into the knee

Interventions

Cingal

Injection into the knee

Intervention Type: COMBINATION_PRODUCT

Cingal

Injection into the knee

Intervention Type: COMBINATION_PRODUCT

Cingal

Injection into the knee

Intervention Type: COMBINATION_PRODUCT

Other Intervention Names

Hyaluronic Acid with Triamcinolone Hexacetonide; Hyaluronic Acid with Triamcinolone Hexacetonide; Hyaluronic Acid with Triamcinolone Hexacetonide

Eligibility 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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Anika Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laszlo Hangody, MD, PhD, DSc

Role: PRINCIPAL_INVESTIGATOR

Semmelweis University, Head of Department of Traumatology

Piotr Lukasik, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

NZOZ Medi-Spatz

Locations

Medical Plus s.r.o.

Uherské Hradiště, , Czechia

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.

Kecskemét, , Hungary

Medidea Bt.

Kiskunfélegyháza, , Hungary

G&V Pharma-Med Bt.

Makó, , Hungary

NZOZ Medi-Spatz

Gliwice, , Poland

ARTIMED Niepubliczny Zaklad Opieki Zdrowotnej w Kielcach

Kielce, , Poland

CenterMed Krakow Sp. z o.o.

Krakow, , Poland

Countries

Czechia; Hungary; Poland

Other Identifiers

Cingal 13-02

Identifier Type: -

Identifier Source: org_study_id