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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02381652 |
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Date of registration:
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03/03/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Repeat Injection of Cingal® for Osteoarthritis of the Knee
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Scientific title:
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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 |
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Date of first enrolment:
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February 2015 |
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Target sample size:
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242 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02381652 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 3
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Countries of recruitment
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Czech Republic
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Czechia
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Hungary
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Poland
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Contacts
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Name:
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Laszlo Hangody, MD, PhD, DSc |
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Address:
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Telephone:
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Email:
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Affiliation:
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Semmelweis University, Head of Department of Traumatology |
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Name:
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Piotr Lukasik, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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NZOZ Medi-Spatz |
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Key inclusion & exclusion criteria
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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.
Age minimum:
40 Years
Age maximum:
75 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Osteoarthritis of the Knee
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Intervention(s)
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Combination Product: Cingal
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Primary Outcome(s)
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Safety Comparison of Adverse Event Profile of Cingal 13-02 vs. Cingal 13-01
[Time Frame: Baseline through 6 weeks post-injection]
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Secondary ID(s)
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Cingal 13-02
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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