Repeat Injection of Cingal® for Osteoarthritis of the Knee
Launched by ANIKA THERAPEUTICS, INC. · Mar 3, 2015
Trial Information
Current as of June 18, 2025
Completed
Keywords
ClinConnect Summary
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 des...
Gender
ALL
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.
About Anika Therapeutics, Inc.
Anika Therapeutics, Inc. is a global biotechnology company focused on developing and commercializing innovative, patient-centric solutions for orthopedic medicine. With a strong emphasis on regenerative therapies, Anika leverages its expertise in hyaluronic acid-based products to address unmet medical needs, particularly in joint preservation and repair. The company's commitment to advancing science is reflected in its robust pipeline of clinical trials aimed at improving outcomes for patients suffering from musculoskeletal conditions. Anika is dedicated to enhancing patient quality of life through cutting-edge research, strategic partnerships, and a collaborative approach to healthcare innovation.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Uherske Hradiste, , Czechia
Budapest, , Hungary
Kiskunfelegyhaza, , Hungary
Mako, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Kecskemet, , Hungary
Gliwice, , Poland
Kielce, , Poland
Krakow, , Poland
Patients applied
Trial Officials
Laszlo Hangody, MD, PhD, DSc
Principal Investigator
Semmelweis University, Head of Department of Traumatology
Piotr Lukasik, MD, PhD
Principal Investigator
NZOZ Medi-Spatz
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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