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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00372801




Trial ID
NCT00372801
Ethics application status
Date submitted
5/09/2006
Date registered
5/09/2006
Date last updated
15/10/2008

Titles & IDs
Public title
Effectiveness Of Single Doses Of Ibuprofen In Patients With Osteoarthritis Of The Knee
Scientific title
A Double-Blind, Randomised, Placebo-Controlled, Cross-Over Pilot Study to Investigate the Efficacy of Ibuprofen in Patients With Osteoarthritis of the Knee Following Administration of a Single Dose
Secondary ID [1] 0 0
COX103843
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Ibuprofen

Treatment: Drugs: Ibuprofen


Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Pain intensity recorded over 0-8 hours using question 1 of the WOMAC (Western Ontario and McMaster University Osteoarthritis Index)pain subscale (visual analog scale).
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Responder rate Patient impression of change - 8 & 24 hrs post dose Time to use of rescue medication (paracetamol)
Timepoint [1] 0 0

Eligibility
Key inclusion criteria
Inclusion criteria:

- Subjects diagnosed with primary Osteoarthritis of the knee.

- Have at least 3 months in symptom duration prior to screening visit.

- Regular user of a prescribed non-steroidal anti-inflammatory drug (NSAID) or selective
cyclo-oxygenase II (COX2) inhibitor for management of knee pain.

- Pain walking on flat surface within specific interval prior to study start.
Minimum age
No limit
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

- History of hypersensitivity to NSAIDS.

- Allergy to Ibuprofen.

- Use of assistive devices other than a cane or knee brace.

- History of specified diseases/illnesses.

- Abnormal blood tests pre-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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
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)
NSW
Recruitment hospital [1] 0 0
GSK Investigational Site - Randwick, Sydney
Recruitment postcode(s) [1] 0 0
2031 - Randwick, Sydney

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
To demonstrate that new drugs work, many complex multidose studies are often required. The
intent of this study is to use Ibuprofen as an example of a marketed pain relief drug to
validate a simpler single dose model for future assessment of new pain drugs.
Trial website
https://clinicaltrials.gov/show/NCT00372801
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries