Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000088246
Ethics application status
Approved
Date submitted
10/12/2008
Date registered
10/02/2009
Date last updated
10/02/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
The efficacy of nalgesic (curcumin) in the treatment
of pain in patients with osteoarthritis of the thumb
Scientific title
The efficacy of nalgesic (curcumin) in the treatment
of pain in patients with osteoarthritis of the thumb
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis 4113 0
Condition category
Condition code
Inflammatory and Immune System 4308 4308 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We aim to recruit 10 volunteers who have the clinical diagnosis of (OsteoArthritis)OA of the thumb joint to enter a
double blinded, placebo controlled study of Curcumin (Nalgesic) with three (single dose) oral administration (tablet) conditions (placebo, normal dose - 1200mg, and double dose 2400mg). This is a cross-over trial. All participants receive all the interventions in different sequences during the study. They act as their own control. There is a full 7 day period between treatments to ensure washout of the trial drug. The trial will be conducted over three consecutive week-ends (Saturdays).
Intervention code [1] 3824 0
Treatment: Other
Comparator / control treatment
placebo - enteric coated cellulose. Single oral dose after baseline measures have been taken.
Control group
Placebo

Outcomes
Primary outcome [1] 5198 0
Pain reduction as measured by subjective self-report using a visual analog scale
Timepoint [1] 5198 0
Baseline, 2, 4, and 6 hours post dose
Secondary outcome [1] 8752 0
Grip strength as measured using a pinchmeter
Timepoint [1] 8752 0
Baseline, 2, 4, and 6 hours post dose
Secondary outcome [2] 9026 0
Range of movement as measured using a goniometer in two ways: abduction and extension of the thumb
Timepoint [2] 9026 0
Baseline, 2, 4 and 6 hours post-dose

Eligibility
Key inclusion criteria
Diagnosis of OA of the thumb by a rheumatologist (Dr Daniel Lewis).
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Under 18 years of age
Current anticoagulant therapy e.g. warfarin
Current treatment for colorectal cancer
Patients with gallstones
Women pregnant, planning to become pregnant or currently breastfeeding

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)
Patients who satisfy the criteria for inclusion by Dr Lewis (rheumatologist) will be added to the total pool of eligible participants and central allocation using a random schedule generated by MS Excel will be applied by a research pharmacist who is off-site. Patients will receive all combination of treatment in this repeated measures design however neither patients nor the experimenters are aware of which phase of the trial each participant is allocated to until the conclusion of the trial.
This study is not measuring the effectiveness of Nalgesic against standard treatments but rather is testing
whether a natural compound can provide pain relief in this patient group. As such, we intend to measure
effectiveness at two doses Vs. placebo.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Using MSExcel, random number generation employed to allocate subject ID to treatment orders. Depending on the sample characteristics, we may use a Block Randomisation or a Minimisation procedure to allocate participants to ensure comparability of the groups on variables such as age, sex, disease activity etc.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
all participants receive all the interventions in different sequences during the study. They act as their own control.
There is a full 7 day period between treatments to ensure washout of the trial drug.
This study is not measuring the effectiveness of Nalgesic against standard treatments but rather is testing
whether a natural compound can provide pain relief in this patient group. As such, we intend to measure
effetiveness at two doses Vs. placebo.
Analysis will be using a repeated measures MANOVA. Independent measure is group assignement (3 levels)
and Dependent measures: Pain, Grip Strength and Range of Movement at Baseline, 2, 4 and 6 hours post dose.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 1346 0
3125

Funding & Sponsors
Funding source category [1] 4273 0
University
Name [1] 4273 0
Deakin University
Country [1] 4273 0
Australia
Funding source category [2] 4274 0
Commercial sector/Industry
Name [2] 4274 0
Nutrition Care Pharmaceuticals
Country [2] 4274 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
Burwood Hwy
Burwood, Victoria 3125
Country
Australia
Secondary sponsor category [1] 3847 0
None
Name [1] 3847 0
Address [1] 3847 0
Country [1] 3847 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6328 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 6328 0
Ethics committee country [1] 6328 0
Australia
Date submitted for ethics approval [1] 6328 0
Approval date [1] 6328 0
18/02/2008
Ethics approval number [1] 6328 0
EC-15-2008

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

Contacts
Principal investigator
Name 35029 0
Address 35029 0
Country 35029 0
Phone 35029 0
Fax 35029 0
Email 35029 0
Contact person for public queries
Name 12376 0
Luke Xantidis
Address 12376 0
Burwood Hwy
Burwood, Victoria 3125
Country 12376 0
Australia
Phone 12376 0
+61 3 556 33154
Fax 12376 0
Email 12376 0
[email protected]
Contact person for scientific queries
Name 3304 0
Luke Xantidis
Address 3304 0
Burwood Hwy
Burwood, Victoria 3125
Country 3304 0
Australia
Phone 3304 0
+61 3 55633154
Fax 3304 0
Email 3304 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.