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Study of FX006 for the Treatment of Pain in Patients With Osteoarthritis of the Knee

Primary Purpose

Osteoarthritis of the Knee

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
FX006
Placebo
TCA IR 40
Sponsored by
Flexion Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis of the Knee focused on measuring osteoarthritis, knee, pain, corticosteroid, intra-articular, injection

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

Sites / Locations

  • PMG Research of Cary
  • PMG Research of Knoxville
  • PMG Research of Knoxville

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Active Comparator

Arm Label

FX006 32mg

Normal Saline

TCA IR 40 mg

Arm Description

Single 5 mL intra-articular (IA) injection Extended-release Formulation

Single 5 mL intra-articular (IA) injection

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

Outcomes

Primary Outcome Measures

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."

Secondary Outcome Measures

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."
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."
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."
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."

Full Information

First Posted
February 3, 2015
Last Updated
February 5, 2018
Sponsor
Flexion Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02357459
Brief Title
Study of FX006 for the Treatment of Pain in Patients With Osteoarthritis of the Knee
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
January 2015 (Actual)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Flexion Therapeutics, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
This study was a double-blind, randomized, single dose design. The study was conducted in male and female patients ≥40 years of age with OA of the knee. Approximately 450 patients with OA of the knee were randomized to 1 of 3 treatment groups (1:1:1) and treated with a single IA injection of: 32 mg FX006, normal saline (placebo), or 40 mg TCA IR. Randomization was stratified by weekly mean of the average daily (24-hour) pain intensity (ADP) scores at baseline, with the following classifications: 5 to <6, 6 to <7, and ≥7. Each patient was evaluated for a total of 24 weeks following a single IA injection. Following screening, safety and efficacy were evaluated at 7 out-patient visits (Days 1 [baseline], Weeks 4, 8, 12, 16, 20, and 24). The study was expected to enroll in approximately 6 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis of the Knee
Keywords
osteoarthritis, knee, pain, corticosteroid, intra-articular, injection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
486 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FX006 32mg
Arm Type
Experimental
Arm Description
Single 5 mL intra-articular (IA) injection Extended-release Formulation
Arm Title
Normal Saline
Arm Type
Placebo Comparator
Arm Description
Single 5 mL intra-articular (IA) injection
Arm Title
TCA IR 40 mg
Arm Type
Active Comparator
Arm Description
Single 1 mL intra-articular (IA) injection TCA IR 40 mg: Immediate-release formulation
Intervention Type
Drug
Intervention Name(s)
FX006
Other Intervention Name(s)
Zilretta
Intervention Description
Single 5 mL IA injection
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Normal Saline
Intervention Description
Single 5 mL IA injection
Intervention Type
Drug
Intervention Name(s)
TCA IR 40
Other Intervention Name(s)
Kenalog®-40 Injection, Kenacort-A 40, Triamcinolone Acetonide Crystalline Suspension (TAcs)
Intervention Description
Single 1 mL IA injection
Primary Outcome Measure Information:
Title
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
Description
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."
Time Frame
Baseline and 12 Weeks
Secondary Outcome Measure Information:
Title
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
Description
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."
Time Frame
Baseline to 12 Weeks
Title
AUE of Change From Baseline in Weekly Mean of the ADP Scores From Baseline to Week 12 for FX006 Relative to TCA IR
Description
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."
Time Frame
Baseline to 12 Weeks
Title
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
Description
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."
Time Frame
Baseline through 12 Weeks
Title
AUE of Change From Baseline in Weekly Mean of the ADP Scores From Baseline to Week 24 for FX006 Relative to Placebo
Description
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."
Time Frame
Baseline to 24 Weeks
Other Pre-specified Outcome Measures:
Title
Change From Baseline to Each Week in Weekly Mean of the ADP Scores
Description
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."
Time Frame
Weeks 1-11 & Weeks 13-24
Title
Change From Baseline Over Time for WOMAC A (Pain Subscale) at Weeks 4, 8, 12, 16, 20 and 24.
Description
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.
Time Frame
Weeks 4, 8, 12, 16, 20, and 24
Title
Change From Baseline Over Time for WOMAC B (Stiffness Subscale) at Weeks 4, 8, 12, 16, 20 and 24
Description
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.
Time Frame
Weeks 4, 8, 12, 16, 20 and 24
Title
Change From Baseline Over Time for WOMAC C (Function Subscale) at Weeks 4, 8, 12, 16, 20 and 24
Description
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.
Time Frame
Weeks 4, 8, 12, 16, 20 and 24
Title
Change From Baseline Over Time for Knee Injury and Osteoarthritis Outcome Score (KOOS) Quality of Life (QOL) Subscale at Weeks 4, 8, 12 and 24
Description
The Knee injury and Osteoarthritis Outcome Score (KOOS) is a participant (patient)-reported outcome measurement instrument, developed to assess the patient's opinion about their knee and associated problems. The KOOS evaluates both short-term and long-term consequences of knee injury and also consequences of primary osteoarthritis (OA). It holds 42 items in five separately scored subscales: KOOS Pain, KOOS Symptoms, Function in daily living (KOOS ADL), Function in Sport and Recreation (KOOS Sport/Rec), and knee-related Quality of Life (KOOS QOL). A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems). Each of the five scores is calculated as the sum of the items included. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as is common in orthopaedic assessment scales and generic measures. Higher scores indicate better quality of life.
Time Frame
Weeks 4, 8, 12, and 24
Title
Responder Status as Defined by Proportion of Patients Experiencing >30% Decrease in Pain From Baseline in Weekly Mean of the ADP Scores at Each Week (Weeks 1-24)
Description
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."
Time Frame
Weeks 1-24
Title
Responder Status as Defined by Proportion of Patients Experiencing >50% Decrease in Pain From Baseline in Weekly Mean of the ADP Scores at Each Week (Weeks 1-24)
Time Frame
Weeks 1-24
Title
Time to Onset of Pain Relief
Description
Time to onset of pain relief is defined as the time from administration of study drug to the first daily pain assessment showing >30% improvement from the weekly mean of the ADP scores at baseline
Time Frame
Baseline to >30% improvement (measured up to 30 days)
Title
Average Weekly and Total Consumption of Rescue Medications at Each Week (Weeks 1-24)
Time Frame
Weeks 1-24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neil Bodick, MD
Organizational Affiliation
Flexion Therapeutics
Official's Role
Study Director
Facility Information:
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85023
Country
United States
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
City
Canoga Park
State/Province
California
ZIP/Postal Code
91303
Country
United States
City
North Hollywood
State/Province
California
ZIP/Postal Code
91606
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
City
Denver
State/Province
Colorado
ZIP/Postal Code
80209
Country
United States
City
Atlantis
State/Province
Florida
ZIP/Postal Code
33462
Country
United States
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34232
Country
United States
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
City
Prairie Village
State/Province
Kansas
ZIP/Postal Code
66206
Country
United States
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
City
Cary
State/Province
North Carolina
ZIP/Postal Code
27518
Country
United States
Facility Name
PMG Research of Cary
City
Cary
State/Province
North Carolina
Country
United States
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28209
Country
United States
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
PMG Research of Knoxville
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37912
Country
United States
Facility Name
PMG Research of Knoxville
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37938
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23606
Country
United States
City
Broadmeadow
State/Province
New South Wales
ZIP/Postal Code
02292
Country
Australia
City
Geelong
State/Province
New South Wales
ZIP/Postal Code
03220
Country
Australia
City
Merewether
State/Province
New South Wales
ZIP/Postal Code
02291
Country
Australia
City
St. Leonards
State/Province
New South Wales
ZIP/Postal Code
02065
Country
Australia
City
Sherwood
State/Province
Queensland
ZIP/Postal Code
04075
Country
Australia
City
Malvern
State/Province
Victoria
ZIP/Postal Code
03145
Country
Australia
City
Quebec
State/Province
Ontario
ZIP/Postal Code
G1W4R4
Country
Canada
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M9V4B4
Country
Canada
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8W1E6
Country
Canada
City
Aalborg
Country
Denmark
City
Ballerup
Country
Denmark
City
Vejle
Country
Denmark
City
Tallinn
Country
Estonia
City
Hong Kong
Country
Hong Kong
City
Vilnius
ZIP/Postal Code
10323
Country
Lithuania
City
Bucharest
ZIP/Postal Code
30463
Country
Romania

12. IPD Sharing Statement

Citations:
PubMed Identifier
34791634
Citation
Ross E, Katz NP, Conaghan PG, Kivitz A, Turk DC, Spitzer AI, Jones DG, Lanier RK, Cinar A, Lufkin J, Kelley SD. Improved Treatment Effect of Triamcinolone Acetonide Extended-Release in Patients with Concordant Baseline Pain Scores on the Average Daily Pain and Western Ontario and McMaster Universities Osteoarthritis Index Pain Scales. Pain Ther. 2022 Mar;11(1):289-302. doi: 10.1007/s40122-021-00335-z. Epub 2021 Nov 17.
Results Reference
derived
PubMed Identifier
30968336
Citation
Langworthy MJ, Conaghan PG, Ruane JJ, Kivitz AJ, Lufkin J, Cinar A, Kelley SD. Efficacy of Triamcinolone Acetonide Extended-Release in Participants with Unilateral Knee Osteoarthritis: A Post Hoc Analysis. Adv Ther. 2019 Jun;36(6):1398-1411. doi: 10.1007/s12325-019-00944-3. Epub 2019 Apr 9.
Results Reference
derived

Learn more about this trial

Study of FX006 for the Treatment of Pain in Patients With Osteoarthritis of the Knee

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