Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001435471
Ethics application status
Approved
Date submitted
12/10/2016
Date registered
14/10/2016
Date last updated
21/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A Phase 2 Study to Assess the Efficacy and Safety of CMX-020 in Treating Osteoarthritis.
Scientific title
A Phase 2 Study to Assess the Efficacy and Safety of CMX-020 in Treating Osteoarthritis.
Secondary ID [1] 290207 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
osteoarthritis 300594 0
Condition category
Condition code
Musculoskeletal 300237 300237 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 295970 0
Treatment: Drugs
Comparator / control treatment
The comparator/ control for this trial is oral 25 mg capsule of matching placebo. Placebo is OmeRx DHA triglycerides containing mixed tocopherols.
Control group
Placebo

Outcomes
Primary outcome [1] 299713 0
The primary measure of efficacy is the change between Day 10 and Baseline of the Treatment Period in the VAS measure of pain.
Timepoint [1] 299713 0
The self reported assessment will be performed by the subject at Screening (Visit 1), immediately prior to commencement of Treatment Period 1 (Visit 2), 7 days post commencement of Treatment Period 1 (Visit 3) and 10 days post commencement of Treatment Period 2 (Visit 4).
Secondary outcome [1] 327929 0
To understand the safety profile of CMX-020 during this study. Safety parameters will include: TEAEs and treatment-emergent SAEs, clinical laboratory tests, vital signs, and ECG results.
The most common AEs from taking CMX-020 repeatedly were mild headache, nausea and gastrointestinal disorders which had been assessed clinically/ history. There have been no known/ possible SAEs associated with this study drug.
Timepoint [1] 327929 0
The safety assessments mentioned above are composite secondary outcome and will be done at Screening (Visit 1), immediately prior to commencement of Treatment Period 1 (Visit 2), 7 days post commencement of Treatment Period 1 (Visit 3) and 10 days post commencement of Treatment Period 2 (Visit 4)..
The blood pressure and pulse will be assessed by pulse oximetry while respiratory rate, physical examination will be assessed clinically. Temperature will be assessed by using a tympanic thermometer while an ECG will be recorded by an instrument which involves the placement of electrodes on the chest wall.
Blood will be collected for hematology and clinical chemistry lab assessments while urine will be collected for urinalysis.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
24/10/2016
Actual
2/12/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 294571 0
Commercial sector/Industry
Name [1] 294571 0
Cytometix AU
Country [1] 294571 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Cytometix AU
Address
10437 Innovation Drive #305
Wauwatosa, WI 53226
Country
United States of America
Secondary sponsor category [1] 293437 0
None
Name [1] 293437 0
Address [1] 293437 0
Country [1] 293437 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296004 0
Ethics committee address [1] 296004 0
Ethics committee country [1] 296004 0
Date submitted for ethics approval [1] 296004 0
21/09/2016
Approval date [1] 296004 0
28/10/2016
Ethics approval number [1] 296004 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 69246 0
Dr Malcolm (Collie) Begg
Address 69246 0
CMAX, a Division of IDT Australia Limited
Level 5,
18a North Terrace, Adelaide,
South Australia, 5000
Country 69246 0
Australia
Phone 69246 0
+61 8 8236 4131
Fax 69246 0
Email 69246 0
cbegg@woc.com.au
Contact person for public queries
Name 69247 0
Peggy Tom
Address 69247 0
C/O Cytometix Inc.
10437 Innovation Drive #305
Wauwatosa, WI 53226
Country 69247 0
United States of America
Phone 69247 0
+1 414.745.8000
Fax 69247 0
Email 69247 0
peggy@cmxtwenty.com
Contact person for scientific queries
Name 69248 0
Peggy Tom
Address 69248 0
C/O Cytometix Inc.
10437 Innovation Drive #305
Wauwatosa, WI 53226
Country 69248 0
United States of America
Phone 69248 0
+1 414.745.8000
Fax 69248 0
Email 69248 0
peggy@cmxtwenty.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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