None listed
Conditions
Brief summary
This is a phase 2 study to assess the efficacy and safety of CMX-020 in treating adults with active osteoarthritis of the knee.
Interventions
The study will consist of Screening, First Treatment Period, Second Treatment Period and Follow-up Period.
During the Screening (Visit 1) subjects will be assessed for eligibility. A Washout Period may be applicable in case subjects are currently on any pharmacologic treatment with NSAID, selective COX-2 inhibitor, or analgesics. Subjects will be asked to discontinue their OA medications during the washout period which is expected to be between 5 days (minimum) and up to 14 days (maximum) depe
The study will consist of Screening, First Treatment Period, Second Treatment Period and Follow-up Period. During the Screening (Visit 1) subjects will be assessed for eligibility. A Washout Period may be applicable in case subjects are currently on any pharmacologic treatment with NSAID, selective COX-2 inhibitor, or analgesics. Subjects will be asked to discontinue their OA medications during the washout period which is expected to be between 5 days (minimum) and up to 14 days (maximum) depending upon the half life of the medications. At Visit 2, subjects will again be assessed for the OA symptoms and will enter into the First Treatment Period provided they continue to meet the study requirements. Eligible subjects will be asked to record their pain scores in the diaries and instructed to self-administer the study medication - one capsule three times a day for 7 days. As Visit 3, subjects will again be assessed for the OA symptoms and if eligible enter into the Second Treatment Period. Subject’s will be randomised to receive either CMX-020, a CMX-020 matched placebo, celecoxib, or celecoxib-matched placebo which will be self-administered by mouth orally three times per day for 10 days. Subjects will return for final assessments at Visit 4, after which subjects will enter the Follow Up Period. During the Follow Up Period and will be followed for 7 days before final exit from the study. The interventional product, CMX-020, (25 mg) will be self-administered by the subjects as an oral capsule three times per day (TID): - in the morning (approx. 06:00 to 08:00) - midday (approx. 12:00 to 14:00) - evening (approx. 19:00 to 21:00) Subjects will take 5 capsules per dose to provide 125 mg. Subjects will be instructed to take each dose with a full glass of room temperature water. Fasting will be required for one hour before until 30 minutes after the dose. Celecoxib will be administered to the subjects as a single capsule per dose orally to provide 200 mg. The date and time of each dose along with the pain scores will be recorded by the patient in the diaries.
Sponsors
Cytometix AU
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
(1) Has satisfied the criteria of the American College of Rheumatology for a diagnosis of primary OA of the knee; (2) Has a Functional Class of I, II, or III; (3) Has satisfied the criteria of an OA flare; (4) Has satisfied the criteria for a “placebo non-responder”; (5) If female is of non-childbearing potential, or is either practicing abstinence or using a medically acceptable form of contraception or double-barrier, is not lactating and has had a negative urine pregnancy test at Visit 1 and Visit 3; (6) If male must agree to use a condom if engaging in sexual intercourse at any time during the duration of the study.
Exclusion criteria
(1) Has received oral, intramuscular, intra-articular or soft tissue injection of a corticosteroid within four weeks prior to enrollment into the study; (2) NSAID or analgesic use within 5 days prior to Visit 3 (Baseline) assessment; (3) Has a diagnosis of any inflammatory arthritis, gout, or acute trauma of the knee; (4) Has an active GI tract, renal, hepatic, or a coagulation disorder; (5) Has known hypersensitivity to analgesics, NSAIDs, celecoxib, COX-2 inhibitors, sulphonamides, acetaminophen (paracematol), or CMX-020.
Outcome results
None listed