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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01487200




Registration number
NCT01487200
Ethics application status
Date submitted
5/12/2011
Date registered
7/12/2011
Date last updated
24/01/2024

Titles & IDs
Public title
Pharmacokinetic and Pharmacodynamic Study of FX006 in Patients With Osteoarthritis of the Knee
Scientific title
A Double-Blind, Randomized, Parallel Group, Active Comparator Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamic Effects (HPA Axis) of FX006 in Patients With Osteoarthritis of the Knee
Secondary ID [1] 0 0
FX006-2011-002
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - FX006 10 mg
Treatment: Drugs - FX006 40 mg
Treatment: Drugs - FX006 60 mg
Treatment: Drugs - TCA IR 40

Experimental: FX006 10mg - Single 3 mL intra-articular (IA) injection Extended-release formulation

Experimental: FX006 40mg - Single 3 mL intra-articular (IA) injection Extended-release formulation

Experimental: FX006 60 mg - Single 3 mL intra-articular (IA) injection Extended-release formulation

Active comparator: TCA IR (40 mg) - Single 1 mL intra-articular (IA) injection Immediate-release formulation


Treatment: Drugs: FX006 10 mg
single 3 mL IA injection

Treatment: Drugs: FX006 40 mg
single 3 mL IA injection

Treatment: Drugs: FX006 60 mg
single 3 mL IA injection

Treatment: Drugs: TCA IR 40
single 1 mL IA injection
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in 24-hour Weighted Mean Serum Cortisol
Timepoint [1] 0 0
Days 1-2, Days 14-15 (Week 2) and Days 42-43 (Week 6)
Primary outcome [2] 0 0
Characterize the Pharmacokinetic Profile of FX006 and TCA IR
Timepoint [2] 0 0
Day 1 (1, 2, 4, 6, 8, 12 and 24 hours post dose) and Days 3, 4, 5, 8, 15, 22, 29, 36 and 43
Secondary outcome [1] 0 0
Change From Baseline in 24-hour Urinary Free Cortisol Excretion
Timepoint [1] 0 0
Baseline to Days 1-2, Baseline to Days 14-15 (Week 2) and Baseline to Days 42-43 (Week 6)
Secondary outcome [2] 0 0
Total 24-hour Urinary Free Cortisol Excretion
Timepoint [2] 0 0
Days 1-2, Days 14-15 (Week 2) and Days 42-43 (Week 6)
Secondary outcome [3] 0 0
Change From Baseline to Each Measured Time Point Post-dose in Morning Serum Cortisol
Timepoint [3] 0 0
Baseline to Days 2, 3, 4, 5, 8, 14, 15, 22, 29, 36, 42 and 43

Eligibility
Key inclusion criteria
Main

* Willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions
* Male or female >=35 years of age
* Diagnosis of unilateral or bilateral OA of the knee for at least 6 months prior to Screening with confirmation of OA according to American College of Rheumatology Criteria for Classification of Idiopathic OA of the Knee (clinical and radiological) based on an X-ray performed within 6 months prior to Screening or during the Screening period
* Body mass index (BMI) = 40 kg/m2
* Willingness to abstain from use of the protocol-specified restricted medications

Main
Minimum age
35 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* History of Reiter's syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, arthritis associated with inflammatory bowel disease, sarcoidosis or amyloidosis
* History of arthritides due to crystals (e.g., gout, pseudogout)
* History of infection in the index joint
* Clinical signs and symptoms of active knee infection or crystal disease of the index knee
* Presence of surgical hardware or other foreign body in the index knee
* Unstable joint (such as a torn anterior cruciate ligament)
* IA corticosteroid (investigational or marketed) in any joint within 3 months of Screening
* IA hyaluronic acid (investigational or marketed) in the index knee within 6 months of Screening
* Oral, inhaled or intranasal corticosteroids (investigational or marketed) within 1 month of Screening
* Prior arthroscopic or open surgery of the index knee within 12 months of Screening
* Planned/anticipated surgery of the index knee during the study period
* History of or active malignancy, with the exception of resected basal cell carcinoma, squamous cell carcinoma of the skin, or resected cervical atypia or carcinoma in situ within 5 years
* Insulin-dependent diabetes
* History of or active Cushing's syndrome
* Any other clinically significant acute or chronic medical conditions (e.g., uncontrolled diabetes)
* Skin breakdown at the knee where the injection would take place
* Women of child-bearing potential not using effective contraception or who are pregnant or nursing

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
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
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
1/07/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2012
Sample size
Target
Accrual to date
Final
24
Recruitment in Australia
Recruitment state(s)
SA,WA
Recruitment hospital [1] 0 0
- Adelaide
Recruitment hospital [2] 0 0
- Perth
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
- Perth

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pacira Pharmaceuticals, Inc
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Neil Bodick, MD
Address 0 0
Flexion Therapeutics
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

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

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01487200