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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01487161




Registration number
NCT01487161
Ethics application status
Date submitted
5/12/2011
Date registered
7/12/2011
Date last updated
18/01/2018

Titles & IDs
Public title
Study of FX006 in Patients With Osteoarthritis of the Knee
Scientific title
A Double-Blind, Randomized, Parallel Group, Dose-Ranging Study Comparing FX006 to Commercially Available Triamcinolone Acetonide Injectable Suspension in Patients With Osteoarthritis of the Knee
Secondary ID [1] 0 0
FX006-2011-001
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
Treatment: Drugs - TCA IR

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

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

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

Active Comparator: TCA IR 40 mg - Single 1 mL intra-articular (IA) injection Immediate-Release Triamcinolone Acetonide


Treatment: Drugs: FX006
Single 3 mL intra-articular injection

Treatment: Drugs: TCA IR
Single 1 mL intra-articular injection

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

Outcomes
Primary outcome [1] 0 0
Change From Baseline to Week 8 in Weekly Mean of the Average Daily (24-hour) Pain Intensity Score for FX006 60 mg vs TCA IR 40 mg - The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine."
Timepoint [1] 0 0
8 weeks
Primary outcome [2] 0 0
Change From Baseline to Week 10 in Weekly Mean of the Average Daily (24-hour) Pain Intensity Score for FX006 60 mg vs TCA IR 40 mg - The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine."
Timepoint [2] 0 0
10 weeks
Primary outcome [3] 0 0
Change From Baseline to Week 12 in Weekly Mean of the Average Daily (24-hour) Pain Intensity Score for FX006 60 mg vs TCA IR 40 mg - The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine."
Timepoint [3] 0 0
12 weeks
Secondary outcome [1] 0 0
Change From Baseline to Each of Weeks 8, 10, and 12 in Weekly Mean of the Average Daily (24-hour) Pain Intensity Score for FX006 10mg and 40 mg vs TCA IR 40 mg - The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine."
Timepoint [1] 0 0
Weeks 8, 10 and 12
Secondary outcome [2] 0 0
Change From Baseline to Each of Weeks 1, 2, 3, 4, 5, 6, 7, 9, and 11 in Weekly Mean of the Average Daily (24-hour) Pain Intensity Score. - The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine."
Timepoint [2] 0 0
Weeks 1-7 and Week 9 and 11
Secondary outcome [3] 0 0
WOMAC A (Pain Subscale) Change From Baseline at Week 8 - The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Timepoint [3] 0 0
8 weeks
Secondary outcome [4] 0 0
WOMAC A1 (Pain on Walking Question) Change From Baseline at Week 8 - The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Timepoint [4] 0 0
8 weeks
Secondary outcome [5] 0 0
WOMAC B (Stiffness Subscale) Change From Baseline at Week 8 - The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Timepoint [5] 0 0
8 weeks
Secondary outcome [6] 0 0
WOMAC C (Function Subscale) Change From Baseline at Week 8 - The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Timepoint [6] 0 0
8 weeks
Secondary outcome [7] 0 0
Percent of Responders According to OMERACT-OARSI Criteria at Week 8 - Outcome Measures in Rheumatoid Arthritis Clinical Trials - Osteoarthritis Research Society International. Responders are defined as participants with high improvement in pain or function.
Timepoint [7] 0 0
8 weeks
Secondary outcome [8] 0 0
Responder Status as Defined by the Proportion of Patients Achieving >50% Improvement From Baseline in the Mean Daily Pain Intensity Scores at Week 8 - The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine."
Timepoint [8] 0 0
8 weeks
Secondary outcome [9] 0 0
Responder Status as Defined by the Proportion of Patients Achieving >30% Improvement From Baseline in the Mean Daily Pain Intensity Scores at Week 8 - The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine."
Timepoint [9] 0 0
8 weeks
Secondary outcome [10] 0 0
Responder Status as Defined by the Proportion of Patients Achieving >20% Improvement From Baseline in the Mean Daily Pain Intensity Scores at Week 8 - The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine."
Timepoint [10] 0 0
8 weeks
Secondary outcome [11] 0 0
Patient Global Impression of Change Scores at Week 8 - The Patient Global Impression of Change is a scale that aims to evaluate all aspects of participants' (patients') health and determining if there has been an improvement or not. The participant selects the one response from the response options that gives the most accurate description of his/her state of health (overall status). This is a 7-point scale, and scores range from 1 (Very Much Improved) to 7 (Very Much Worse). Lower scores indicate better health status.
Timepoint [11] 0 0
Week 8
Secondary outcome [12] 0 0
Clinical Global Impression of Change Scores at Week 8 - The Clinical Global Impression of Change is a scale that the clinician uses to assess the participants' global function and determine if there has been an improvement or not. The clinician selects one response from the response options that gives the most accurate description of the participant's state of health (overall status). This is a 7-point scale, and scores range from 1 (Very Much Improved) to 7 (Very Much Worse). Lower scores indicate better health status.
Timepoint [12] 0 0
8 weeks
Secondary outcome [13] 0 0
Average Weekly and Total Consumption of Rescue Medications Over 8 Weeks.
Timepoint [13] 0 0
8 weeks

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 >=40 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

- Qualifying mean score on the 24-h average pain score (0-10 numeric rating scale)

- Body mass index (BMI) = 40 kg/m2

- Willingness to abstain from use of restricted medications

Main
Minimum age
40 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

- Ipsilateral hip OA

- Fibromyalgia, chronic pain syndrome or other concurrent medical or arthritic
conditions which could interfere with the evaluation of the index knee

- 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 and 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

- Active or history of malignancy within the last 5 years, with the exception of
resected basal cell carcinoma, squamous cell carcinoma of the skin, or resected
cervical atypia or carcinoma in situ

- Insulin-dependent diabetes

- Active psychiatric disorder including psychosis and major depressive disorder

- 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)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
- Broadmeadow
Recruitment hospital [2] 0 0
- Kogarah
Recruitment hospital [3] 0 0
- St. Leonards
Recruitment hospital [4] 0 0
- Wollongong
Recruitment hospital [5] 0 0
- Kippa-Ring
Recruitment hospital [6] 0 0
- Maroochydore
Recruitment hospital [7] 0 0
- Sherwood
Recruitment hospital [8] 0 0
- Clayton
Recruitment hospital [9] 0 0
- Malvern East
Recruitment postcode(s) [1] 0 0
- Broadmeadow
Recruitment postcode(s) [2] 0 0
- Kogarah
Recruitment postcode(s) [3] 0 0
- St. Leonards
Recruitment postcode(s) [4] 0 0
- Wollongong
Recruitment postcode(s) [5] 0 0
- Kippa-Ring
Recruitment postcode(s) [6] 0 0
- Maroochydore
Recruitment postcode(s) [7] 0 0
- Sherwood
Recruitment postcode(s) [8] 0 0
- Clayton
Recruitment postcode(s) [9] 0 0
- Malvern East
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Pennsylvania
Country [3] 0 0
Canada
State/province [3] 0 0
Nova Scotia
Country [4] 0 0
Canada
State/province [4] 0 0
Ontario
Country [5] 0 0
Canada
State/province [5] 0 0
Quebec

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, efficacy and pharmacokinetics of FX006
in patients with osteoarthritis of the knee.
Trial website
https://clinicaltrials.gov/show/NCT01487161
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Neil Bodick, MD, PhD
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