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Trial registered on ANZCTR


Registration number
ACTRN12606000162516
Ethics application status
Approved
Date submitted
28/04/2006
Date registered
8/05/2006
Date last updated
5/11/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Randomised placebo controlled trial on the safety and efficacy of BSP-201 in osteoarthritis
Scientific title
Randomised placebo controlled trial on the safety and efficacy to reduce pain, stiffness and physical disfunction of a Sheabutter Extract (BSP-201) in osteoarthritis
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis of the knees and/or hips 1135 0
Condition category
Condition code
Musculoskeletal 1214 1214 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
2250mg/day Sheabutter extract (BSP-201) capsules over a 15 week period
Intervention code [1] 1007 0
None
Comparator / control treatment
Placebo
Control group
Placebo

Outcomes
Primary outcome [1] 1646 0
Change in Western Ontario and McMaster Universities (WOMAC) score from baseline
Timepoint [1] 1646 0
Measured at week 5, week 10 and at endpoint at 15 weeks
Secondary outcome [1] 2942 0
Change in Comprehensive Osteoarthritis Test (COAT) score.
Timepoint [1] 2942 0
From baseline, measured at week 5, week 10 and at endpoint at 15 weeks.
Secondary outcome [2] 2943 0
Change in Quality of Life (Short Form 36).
Timepoint [2] 2943 0
From baseline, measured at week 5, week 10 and at endpoint at 15 weeks.
Secondary outcome [3] 2944 0
Paracetamol Usage.
Timepoint [3] 2944 0
15 weeks
Secondary outcome [4] 2945 0
Change osteoarthritis biomarkers including markers for fibrinolysis, coagulation, inflammation, cartilage synthesis and degredation and bone formation and resortion.
Timepoint [4] 2945 0
From baseline, measured at week 10 and endpoint at 15 weeks.

Eligibility
Key inclusion criteria
X-ray and clinical evidence of osteoarthritis of the knees and/or hipsTotal WOMAC score of 30 or more at baseline.Good general health.Adequate venous access.
Minimum age
18 Years
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
A history of trauma with the affected joint.Gout, rheumatoid arthritis or other inflammatory joint condition.Allergy to Sheabutter.Use of anti-arthritic agents before baseline (3 weeks for anti-inflammatory agents inlcuding aspirin, 4 weeks for corticosteroids and 6 weeks for complementary medicines).Liver function tests greater than 2 times the upper limit of normal at baseline.History of alcohol or substance abuse.Females who are pregnant, lactating, planning to become pregnant or unwilling to use birth control during the study.Participants unwilling or unable to comply with the study protocol.Participants who have participated another clincial trial in the last 30 days.History of serious or unstable cardiac, renal, hypertensive, pulmonary, endocrine, neurologic or neuropsychiatric disorder.

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)
Both the active and placebo treatments will be diepensed in identical bottles and be indistinguishable in appearance and odour. the bottles will be randomised, labelled and packaged by sponsor. Only when the study data has been cleaned and the sudy database has been locked will unblinding will occur.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation schedule will be generated and held by the sponsor. A computer generated schedule willbe used to assign wither the active or placebo group in blocks.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
15 weeks duration
Phase
Phase 2 / Phase 3
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1326 0
Commercial sector/Industry
Name [1] 1326 0
BSP Pharma A/S
Address [1] 1326 0
Denmark
Country [1] 1326 0
Denmark
Primary sponsor type
Commercial sector/Industry
Name
BSP Pharma A/S (this is the full name of company)
Address
Denmark
Country
Denmark
Secondary sponsor category [1] 1171 0
None
Name [1] 1171 0
Nil
Address [1] 1171 0
Country [1] 1171 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2650 0
Australian Centre for Complementary Medicine Education and Research- Mater Health Services Human Research Ethics Committee
Ethics committee address [1] 2650 0
Brisbane premises on the Floor 2, Community Services Building, Mater Health Services, South Brisbane
Ethics committee country [1] 2650 0
Australia
Date submitted for ethics approval [1] 2650 0
Approval date [1] 2650 0
Ethics approval number [1] 2650 0
929E
Ethics committee name [2] 2651 0
Australian Centre for Complementary Medicine Education and Research-University of Queensland Medical Research Ethics Committee
Ethics committee address [2] 2651 0
Brisbane premises on the Floor 2, Community Services Building, Mater Health Services, South Brisbane
Ethics committee country [2] 2651 0
Australia
Date submitted for ethics approval [2] 2651 0
Approval date [2] 2651 0
Ethics approval number [2] 2651 0
2006000236
Ethics committee name [3] 2652 0
Australian Centre for Complementary Medicine Education and Research-Southern Cross University Human Research Ethics Committee
Ethics committee address [3] 2652 0
Brisbane premises on the Floor 2, Community Services Building, Mater Health Services, South Brisbane
Ethics committee country [3] 2652 0
Australia
Date submitted for ethics approval [3] 2652 0
Approval date [3] 2652 0
Ethics approval number [3] 2652 0
ECN-06-30

Summary
Brief summary
The purpose of the study is to determin the safety, efficacy and potential modes of action of BSP-201 in adults with osteoarthritis of the knees and/or hips. It will be a randomised, double-blind (both subjects and investigators are blinded), placebo-controlled, parallel study.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35978 0
Address 35978 0
Country 35978 0
Phone 35978 0
Fax 35978 0
Email 35978 0
Contact person for public queries
Name 10196 0
Peta-Anne Paul-Brent
Address 10196 0
Floor 2, Community Sevices Building
Mater Health Services
39 Annerley Rd
South Brisbane QLD 4101
Country 10196 0
Australia
Phone 10196 0
+61 7 38406112
Fax 10196 0
+61 7 38406119
Email 10196 0
p.kerr@ uq.edu.au
Contact person for scientific queries
Name 1124 0
Dr Phillip Cheras
Address 1124 0
Floor 2 Community Sevices Building
Mater Health Services
39 Annerley Rd
South Brisbane QLD 4101
Country 1124 0
Australia
Phone 1124 0
+61 7 38406111
Fax 1124 0
+61 7 38406119
Email 1124 0
p.cheras@uq.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary