Repeat Injection of Cingal® for Osteoarthritis of the Knee

NCT02381652 | Completed Phase 3 Results DMC FDA Drug FDA Device

• 1 other identifier: Cingal 13-02
• Study Type: interventional
• Target: 242
• Locations: 3 countries
• Sites: 10

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.

Conditions

Osteoarthritis of the Knee

Keywords

Osteoarthritis; Intra-articular Injection; Hyaluronic Acid; Triamcinolone Hexacetonide

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline through 6 weeks post-injection

Study Arms (3)

Cingal/Cingal

EXPERIMENTAL

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

Cingal/Monovisc

EXPERIMENTAL

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

Cingal/Saline

EXPERIMENTAL

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

Interventions

Cingal COMBINATION_PRODUCT

Injection into the knee

Also known as: Hyaluronic Acid with Triamcinolone Hexacetonide

Cingal/Cingal

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Anika Therapeutics, Inc.: lead

Study Sites (10)

Medical Plus s.r.o.

Uherské Hradiště, Czechia

Location

Belvaros-Lipotvaros, Orthopedic Outpatient Clinic

Budapest, Hungary

Location

Semmelweis University, Department of Orthopaedics

Budapest, Hungary

Location

Uzsoki Hospital, Department of Traumatology

Budapest, Hungary

Location

Jutrix Healthcare Services Ltd.

Kecskemét, Hungary

Location

Medidea Bt.

Kiskunfélegyháza, Hungary

Location

G&V Pharma-Med Bt.

Makó, Hungary

Location

NZOZ Medi-Spatz

Gliwice, Poland

Location

ARTIMED Niepubliczny Zaklad Opieki Zdrowotnej w Kielcach

Kielce, Poland

Location

CenterMed Krakow Sp. z o.o.

Krakow, Poland

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Interventions

Hyaluronic Acid; triamcinolone hexacetonide

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Limitations and Caveats

Cingal 13-02 is a follow-on safety trial to Cingal 13-01 and collected safety data only from an open-label injection of Cingal.

Results Point of Contact

• Title: Carol Pekar, VP Clinical Affairs
• Organization: Anika

cpekar@anikatherapeutics.com

781.457.9218

Study Officials

• Laszlo Hangody, MD, PhD, DSc

  Semmelweis University, Head of Department of Traumatology

  PRINCIPAL INVESTIGATOR

• Piotr Lukasik, MD, PhD

  NZOZ Medi-Spatz

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 3, 2015
• First Posted: March 6, 2015
• Study Start: February 1, 2015
• Primary Completion: April 1, 2015
• Study Completion: May 1, 2015
• Last Updated: March 22, 2022
• Results First Posted: September 3, 2020

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1); PL (3); HU (6)