Back to resultsStudy of FX006 vs Normal Saline in Patients With Osteoarthritis of the Knee
Primary Purpose
Osteoarthritis of the Knee
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
FX006 32 mg
Placebo
FX006 16 mg
Sponsored by
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
Main 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 documented diagnosis of OA of the index knee made 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
- 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 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 or clinical signs and symptoms of infection in the index joint
- Knee pain that is not clinically attributable to OA of the knee (e.g., 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 to or greater than the index knee pain
- 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) corticosteroids (investigational or marketed) within 3 months of Screening
- Oral corticosteroids (investigational or marketed) within 1 month of Screening
- Inhaled, intranasal and topical corticosteroids (investigational or marketed) within 2 weeks 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
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
FX006 16 mg
FX006 32 mg
Placebo
Arm Description
Single 5 mL intra-articular (IA) injection Extended-release formulation
Single 5 mL intra-articular (IA) injection Extended-release formulation
Normal Saline Single 5 mL intra-articular (IA) injection
Outcomes
Primary Outcome Measures
Change From Baseline to Week 12 in the Weekly Mean of the Average Daily (24-hr) Pain Intensity Scores for 32 mg FX006 Versus Placebo
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."
Secondary Outcome Measures
Change From Baseline to Week 12 for WOMAC C (Function Subscale)
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.
Change From Baseline to Week 12 for Patient Global Impression of Change (PGIC)
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.
Change From Baseline to Week 16 and Then Week 20 and Then Week 24 in the Weekly Mean of the Average Daily (24-hour) Pain Intensity Scores
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."
Full Information
NCT ID
NCT02116972
First Posted
April 15, 2014
Last Updated
March 19, 2018
Sponsor
Flexion Therapeutics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02116972
Brief Title
Study of FX006 vs Normal Saline in Patients With Osteoarthritis of the Knee
Official Title
A Double-Blind, Randomized, Parallel Group, Dose-Ranging 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
March 2018
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (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 magnitude and duration of pain relief of a single IA injection of 2 doses (16 and 32 mg) of FX006, an extended-release formulation of TCA, relative to normal saline (placebo control).
Detailed Description
This was a double-blind, randomized, parallel group, dose-ranging, single-dose study. The study was conducted in male and female patients ≥40 years of age with OA of the knee.
Approximately 300 patients with OA of the knee were randomized, using a centralized randomization procedure, to 1 of 3 treatment groups (1:1:1) and treated with a single IA injection of:
16 mg FX006,
32 mg FX006, or
normal saline (placebo).
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 over approximately 6 to 7 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 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
310 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FX006 16 mg
Arm Type
Experimental
Arm Description
Single 5 mL intra-articular (IA) injection Extended-release formulation
Arm Title
FX006 32 mg
Arm Type
Experimental
Arm Description
Single 5 mL intra-articular (IA) injection Extended-release formulation
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Normal Saline Single 5 mL intra-articular (IA) injection
Intervention Type
Drug
Intervention Name(s)
FX006 32 mg
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)
FX006 16 mg
Intervention Description
Single 5 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 Intensity Scores for 32 mg FX006 Versus Placebo
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
Baseline and Week 12
Secondary Outcome Measure Information:
Title
Change From Baseline to Week 12 for WOMAC C (Function Subscale)
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
Baseline and Week 12
Title
Change From Baseline to Week 12 for Patient Global Impression of Change (PGIC)
Description
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.
Time Frame
Baseline and Week 12
Title
Change From Baseline to Week 16 and Then Week 20 and Then Week 24 in the Weekly Mean of the Average Daily (24-hour) Pain Intensity Scores
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
Baseline and Weeks 16, 20 and 24
Other Pre-specified Outcome Measures:
Title
Percent of Responders According to Outcomes Measures in OMERACT-OARSI Strict Criteria
Description
Outcome Measures in Rheumatoid Arthritis Clinical Trials - Osteoarthritis Research Society International. (OMERACT-OARSI) Responders are defined as participants with high improvement in pain or function.
Time Frame
Weeks 4, 8 and 12
Title
Change From Baseline to Week 12 for WOMAC C (Function Subscale)
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
Baseline and Week 12
Title
Change From Baseline to Week 12 for Patient Global Impression of Change (PGIC)
Description
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.
Time Frame
Baseline and Week 12
Title
Change From Baseline to Each Week in Weekly Mean of the ADP Intensity Scores
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."Weeks 12, 16, 20, and 24 are specified as the primary and secondary endpoints for the 32 mg group and the placebo group
Time Frame
Baseline and Up to Week 24
Title
Change From Baseline to Each of Weeks 4, 8, 16, 20, and 24 in WOMAC-C-function
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
Baseline and Weeks 4, 8, 16, 20 and 24 (Week 12 data is represented in the secondary outcome measure)
Title
Change From Baseline to Each of Weeks 4, 8, 12, 16, 20, and 24 in WOMAC-A Pain
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
Baseline and Weeks 4, 8, 12, 16, 20 and 24
Title
Change From Baseline to Each of Weeks 4, 8, 16, 20, and 24 in PGIC
Description
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.
Time Frame
Baseline and Weeks 4, 8, 16, 20, and 24 (Week 12 data reported in secondary outcome measure)
Title
Proportion of Patients Experiencing a >20%, 30% and 50% Decrease in Pain From Baseline in Weekly Mean of the Average Daily (24-hr) Pain Intensity Scores at Week 12
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
12 weeks
Title
Time to Onset of Pain Relief
Description
Time to onset of pain relief in days is defined as the time from administration of study treatment to the first pain assessment showing >30% improvement from the weekly average daily pain score at baseline.
Time Frame
Baseline up to 24 Weeks after administration of study treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Main 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 documented diagnosis of OA of the index knee made 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
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 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 or clinical signs and symptoms of infection in the index joint
Knee pain that is not clinically attributable to OA of the knee (e.g., 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 to or greater than the index knee pain
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) corticosteroids (investigational or marketed) within 3 months of Screening
Oral corticosteroids (investigational or marketed) within 1 month of Screening
Inhaled, intranasal and topical corticosteroids (investigational or marketed) within 2 weeks 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
Anniston
State/Province
Alabama
ZIP/Postal Code
36207
Country
United States
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35216
Country
United States
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85023
Country
United States
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
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
El Cajon
State/Province
California
ZIP/Postal Code
92020
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90036
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
Stamford
State/Province
Connecticut
ZIP/Postal Code
06905
Country
United States
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
City
Orlando
State/Province
Florida
ZIP/Postal Code
32825
Country
United States
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33781
Country
United States
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47713
Country
United States
City
Paducah
State/Province
Kentucky
ZIP/Postal Code
42003
Country
United States
City
Wheaton
State/Province
Maryland
ZIP/Postal Code
20902
Country
United States
City
New Bedford
State/Province
Massachusetts
ZIP/Postal Code
02740
Country
United States
City
Troy
State/Province
Michigan
ZIP/Postal Code
48085
Country
United States
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64114
Country
United States
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10018
Country
United States
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
City
Altoona
State/Province
Pennsylvania
ZIP/Postal Code
16602
Country
United States
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77055
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78258
Country
United States
City
Victoria
State/Province
Texas
ZIP/Postal Code
77901
Country
United States
City
Danville
State/Province
Virginia
ZIP/Postal Code
24541
Country
United States
City
Kitchener
State/Province
Ontario
Country
Canada
City
Sarnia
State/Province
Ontario
Country
Canada
City
Toronto
State/Province
Ontario
Country
Canada
City
Windsor
State/Province
Ontario
Country
Canada
City
Quebec
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
29088579
Citation
Conaghan PG, Cohen SB, Berenbaum F, Lufkin J, Johnson JR, Bodick N. Brief Report: A Phase IIb Trial of a Novel Extended-Release Microsphere Formulation of Triamcinolone Acetonide for Intraarticular Injection in Knee Osteoarthritis. Arthritis Rheumatol. 2018 Feb;70(2):204-211. doi: 10.1002/art.40364. Epub 2017 Dec 20.
Results Reference
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Learn more about this trial
Study of FX006 vs Normal Saline in Patients With Osteoarthritis of the Knee
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