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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT01487200
Ethics application status
Date submitted
5/12/2011
Date registered
7/12/2011
Date last updated
6/12/2019

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 - The primary pharmacodynamic endpoint was change from baseline (pre-dose) to Day 1-2, Day 14-15 (Week 2) and Day 42-43 (Week 6) in 24-hour weighted mean serum cortisol. This is defined as AUC over the 0-24 hour measurement period divided by 24
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 - Concentrations below the limit of quantification of 50 pg/mL were treated as 0.
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 - Least square mean difference against TCA IR 40 mg
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
Gender
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
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)
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
Flexion Therapeutics, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study was to evaluate the safety, pharmacokinetics and pharmacodynamics
of FX006 in patients with osteoarthritis of the knee.
Trial website
https://clinicaltrials.gov/show/NCT01487200
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

Summary results
Other publications