Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000226404
Ethics application status
Approved
Date submitted
24/04/2007
Date registered
30/04/2007
Date last updated
21/09/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
A double-blind cross-over placebo controlled study of Evogen® Topical gel in the treatment of mild to moderate pain associated with osteoarthritis
Scientific title
Participants: Osteoarthritis of the knees
Intervention: Evogen® Topical gel
Comparator: Placebo
Outcome: Reduction in VAS pain scale scores
Universal Trial Number (UTN)
Trial acronym
N/A
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mild to moderate pain in osteoarthritis 1757 0
Condition category
Condition code
Musculoskeletal 1849 1849 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Evogen® Topical gel (nutraceutical) 4 cc to be applied externally to the affected area every 6 hours for 1 week. Placebo dose protocol the same. Participants will use one treatment in the first week of the study, washout for 2 weeks then apply the other treatment for a further 7 days.
Intervention code [1] 1719 0
Treatment: Other
Comparator / control treatment
Placebo is applied externally to the affected area every 6 hours for 1 week. Placebo will be manufactured from the same exipient base.
Control group
Placebo

Outcomes
Primary outcome [1] 2589 0
Reduction in VAS pain scale scores
Timepoint [1] 2589 0
Measured 3 times on day 1 then once daily for a further 6 days.
Secondary outcome [1] 4448 0
COAT (Comprehensive Osteoarthritis Test) - This instrument consists of four items measured on 100mm visual analogue scale (VAS) response scales: joint pain, stiffness, difficulties with physical activities, and overall symptoms.
Timepoint [1] 4448 0
Measured 3 times on day one then daily for a further 6 days. These outcomes will be measured once a day for a further 6 days.
Secondary outcome [2] 4449 0
Paracetamol usage – participants will record paracetamol usage on a daily basis in a study diary.
Timepoint [2] 4449 0
Measured 3 times on day one then daily for a further 6 days. These outcomes will be measured once a day for a further 6 days.

Eligibility
Key inclusion criteria
X-ray and clinical evidence of osteoarthritis of the kneesIn good general healthAdequate venous accessParticipants who are medication free or stable on Glucosamine, NSAID (non steroidal anti inflammatory drugs) or Fish Oil treatment for 3 months.Participants of childbearing age who agree to continue using birth control measures for the duration of the study.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
A history of trauma associated with the affected jointRheumatoid or other inflammatory joint conditionsGoutParticipants with a VAS score above 7 at baseline.Participants who have just commenced on a treatment regimen for arthritis Use of corticosteroids (intra-articular or systematic) within 4 weeks prior to baseline and throughout the studyLiver function tests greater than 3 times the upper limit of normal at baselineHistory of alcohol or substance abuseFemale participants who are lactating, pregnant or planning to become pregnantParticipants who have participated in another clinical trial in the last 30 daysParticipants unwilling to comply with the study protocolAny other condition, which in the opinion of the investigators could compromise the study.

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)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Participants involved in the study will be blinded and study staff (therapists, assessors and clinicians and data analysts) will be blinded
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/05/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1996 0
Commercial sector/Industry
Name [1] 1996 0
Blackmore's Pty Ltd
Country [1] 1996 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Blackmore's Pty Ltd
Address
Country
Australia
Secondary sponsor category [1] 1807 0
None
Name [1] 1807 0
N/A
Address [1] 1807 0
Country [1] 1807 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3703 0
NatMed-Research Department fo Natural and Complementary Medicine Southern Cross University
Ethics committee address [1] 3703 0
Ethics committee country [1] 3703 0
Australia
Date submitted for ethics approval [1] 3703 0
Approval date [1] 3703 0
16/04/2007
Ethics approval number [1] 3703 0
ECN-07-35

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

Contacts
Principal investigator
Name 27822 0
Address 27822 0
Country 27822 0
Phone 27822 0
Fax 27822 0
Email 27822 0
Contact person for public queries
Name 10908 0
Dr Joan O'Connor
Address 10908 0
NatMed-Research
Department of Natural and Complementary Medicine
Southern Cross University
Military Road
Lismore NSW 2480
Country 10908 0
Australia
Phone 10908 0
+61 2 66203649
Fax 10908 0
+61 2 66203307
Email 10908 0
[email protected]
Contact person for scientific queries
Name 1836 0
Dr Joan O'Connor
Address 1836 0
NatMed-Research
Department of Natural and Complementary Medicine
Southern Cross University
Military Road
Lismore NSW 2480
Country 1836 0
Australia
Phone 1836 0
+61 2 66203649
Fax 1836 0
+61 2 66203307
Email 1836 0
[email protected]

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.