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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02357459




Registration number
NCT02357459
Ethics application status
Date submitted
3/02/2015
Date registered
6/02/2015
Date last updated
7/02/2018

Titles & IDs
Public title
Study of FX006 for the Treatment of Pain in Patients With Osteoarthritis of the Knee
Scientific title
A Double-Blind, Randomized, Single-Dose Study to Assess the Safety and Efficacy of FX006 for the Treatment of Pain in Patients With Osteoarthritis of the Knee
Secondary ID [1] 0 0
FX006-2014-008
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 - Placebo
Treatment: Drugs - TCA IR 40

Experimental: FX006 32mg - Single 5 mL intra-articular (IA) injection Extended-release Formulation

Placebo Comparator: Normal Saline - Single 5 mL intra-articular (IA) injection

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


Treatment: Drugs: FX006
Single 5 mL IA injection

Treatment: Drugs: Placebo
Single 5 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 to Week 12 in the Weekly Mean of the Average Daily (24-hr) Pain (ADP) Intensity Scores for 32 mg FX006 Versus Placebo - The pain intensity score is measured using an 11-point numeric rating scale (NRS), where ) indicates "no pain" and 10 indicates "pain as bad as you can imagine."
Timepoint [1] 0 0
Baseline and 12 Weeks
Secondary outcome [1] 0 0
Area Under the Effect Curve (AUE) of Change From Baseline in the Weekly Mean of the ADP Scores From Baseline to Week 12 for FX006 Relative to Placebo - The pain intensity score is measured using an 11-point numeric rating scale (NRS), where ) indicates "no pain" and 10 indicates "pain as bad as you can imagine."
Timepoint [1] 0 0
Baseline to 12 Weeks
Secondary outcome [2] 0 0
AUE of Change From Baseline in Weekly Mean of the ADP Scores From Baseline to Week 12 for FX006 Relative to TCA IR - The pain intensity score is measured using an 11-point numeric rating scale (NRS), where ) indicates "no pain" and 10 indicates "pain as bad as you can imagine."
Timepoint [2] 0 0
Baseline to 12 Weeks
Secondary outcome [3] 0 0
Change From Baseline to Week 12 in the Weekly Mean of the ADP Scores From Baseline to Week 12 for FX006 Relative to TCA IR - The pain intensity score is measured using an 11-point numeric rating scale (NRS), where ) indicates "no pain" and 10 indicates "pain as bad as you can imagine."
Timepoint [3] 0 0
Baseline through 12 Weeks
Secondary outcome [4] 0 0
AUE of Change From Baseline in Weekly Mean of the ADP Scores From Baseline to Week 24 for FX006 Relative to Placebo - The pain intensity score is measured using an 11-point numeric rating scale (NRS), where ) indicates "no pain" and 10 indicates "pain as bad as you can imagine."
Timepoint [4] 0 0
Baseline to 24 Weeks

Eligibility
Key inclusion criteria
- 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

- Has symptoms associated with OA of the index knee for at least 6 months prior to
Screening

- Currently meets American College of Rheumatology (ACR) Criteria (clinical and
radiological) for OA

- Kellgren-Lawrence (K-L) Grade 2 or 3 in the index knee per Screening X-ray

- Index knee pain for > 15 days over the last month

- 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
Minimum age
40 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Any condition that could possibly confound the patient's assessment of index knee pain
in judgement of the investigator (i.e., iIpsilateral hip OA, gout, radicular low back
pain and hip pain that is referred to the knee that could cause misclassification,
pain in any other area of the lower extremities or back that is equal or greater than
the index knee pain)

- Fibromyalgia, Reiter's syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing
spondylitis, arthritis associated with inflammatory bowel disease

- History of infection in the index knee

- Clinical signs and symptoms of active knee infection or crystal disease of the index
knee within 1 month of Screening

- Unstable joint within 12 months of screening

- 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

- Intramuscular (IM) or oral corticosteroids (investigational or marketed) within 1
month of Screening

- Any other IA investigational drug/biologic within 6 months of Screening

- Prior use of FX006

- 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 3
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
- Geelong
Recruitment hospital [3] 0 0
- Merewether
Recruitment hospital [4] 0 0
- St. Leonards
Recruitment hospital [5] 0 0
- Sherwood
Recruitment hospital [6] 0 0
- Malvern
Recruitment postcode(s) [1] 0 0
02292 - Broadmeadow
Recruitment postcode(s) [2] 0 0
03220 - Geelong
Recruitment postcode(s) [3] 0 0
02291 - Merewether
Recruitment postcode(s) [4] 0 0
02065 - St. Leonards
Recruitment postcode(s) [5] 0 0
04075 - Sherwood
Recruitment postcode(s) [6] 0 0
03145 - Malvern
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
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Kansas
Country [6] 0 0
United States of America
State/province [6] 0 0
New Mexico
Country [7] 0 0
United States of America
State/province [7] 0 0
North Carolina
Country [8] 0 0
United States of America
State/province [8] 0 0
Pennsylvania
Country [9] 0 0
United States of America
State/province [9] 0 0
Tennessee
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
United States of America
State/province [11] 0 0
Virginia
Country [12] 0 0
Canada
State/province [12] 0 0
Ontario
Country [13] 0 0
Denmark
State/province [13] 0 0
Aalborg
Country [14] 0 0
Denmark
State/province [14] 0 0
Ballerup
Country [15] 0 0
Denmark
State/province [15] 0 0
Vejle
Country [16] 0 0
Estonia
State/province [16] 0 0
Tallinn
Country [17] 0 0
Hong Kong
State/province [17] 0 0
Hong Kong
Country [18] 0 0
Lithuania
State/province [18] 0 0
Vilnius
Country [19] 0 0
Romania
State/province [19] 0 0
Bucharest

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 assess the safety and efficacy of FX006 for the treatment of
pain in patients with osteoarthritis of the knee.
Trial website
https://clinicaltrials.gov/show/NCT02357459
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