Clinical trial NCT02381652: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoarthritis of the Knee
Keywords: Osteoarthritis
Intra-articular Injection
Hyaluronic Acid
Triamcinolone Hexacetonide
Lead sponsor: Anika Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2015-03-06
Enrollment: 242
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Number of Treatment-Emergent Adverse Events: Cingal 13-02 vs. Cingal 13-01
timeFrame: Baseline through 6 weeks post-injection
Secondary outcomes:
Other outcomes:
Locations:
city: Uherske Hradiste
country: Czechia
facility: Medical Plus s.r.o.
city: Budapest
country: Hungary
facility: Belvaros-Lipotvaros, Orthopedic Outpatient Clinic
city: Budapest
country: Hungary
facility: Semmelweis University, Department of Orthopaedics
city: Budapest
country: Hungary
facility: Uzsoki Hospital, Department of Traumatology
city: Kecskemet
country: Hungary
facility: Jutrix Healthcare Services Ltd.
city: Kiskunfelegyhaza
country: Hungary
facility: Medidea Bt.
city: Mako
country: Hungary
facility: G&V Pharma-Med Bt.
city: Gliwice
country: Poland
facility: NZOZ Medi-Spatz
city: Kielce
country: Poland
facility: ARTIMED Niepubliczny Zaklad Opieki Zdrowotnej w Kielcach
city: Krakow
country: Poland
facility: CenterMed Krakow Sp. z o.o.
Study officials:
affiliation: Semmelweis University, Head of Department of Traumatology
name: Laszlo Hangody, MD, PhD, DSc
role: PRINCIPAL_INVESTIGATOR
affiliation: NZOZ Medi-Spatz
name: Piotr Lukasik, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: