Back to resultsStudy of FX005 for the Treatment of Pain in Patients With Osteoarthritis of the Knee
Primary Purpose
Osteoarthritis, Knee
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
FX005
Placebo 1 (Carrier)
Placebo 2 (Diluent)
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Osteoarthritis, knee, intra-articular, safety, efficacy, pharmacokinetics, pain
Eligibility Criteria
Inclusion Criteria:
- Male or female ≥40 years of age
- Diagnosis of unilateral or bilateral osteoarthritis of the knee for at least 6 months; confirmation of osteoarthritis according to American College of Rheumatology Criteria (clinical and radiological)
- Kellgren-Lawrence grades II or III
- Mean score for the WOMAC A subscale (pain) between 2.0 and 3.5 for the index knee
- Score of 2-3 for the WOMAC A1 score (pain on walking) for the index knee
- Body mass index ≤ 40 kg/m2
- Willingness to abstain from use of restricted medications during the study
- Willingness and ability to comply with the study procedures and visit schedule
Exclusion Criteria:
- Kellgren-Lawrence Grade 0, I or IV radiographic stage of the index knee
- Clinically apparent tense effusion in index knee
- Presence of surgical hardware or other foreign body in the index knee
- Clinical signs and symptoms of active knee infection or crystal disease
- Intra-articular corticosteroid within 3 months of Screening
- Intra-articular hyaluronic acid within 6 months of Screening
- Other intra-articular therapy within 3 months 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 malignancy or other serious, non-malignant, significant, acute or chronic medical (e.g.. uncontrolled diabetes) or active psychiatric illness
- Skin breakdown at the knee where the injection would take place
- Women who are pregnant, nursing or likely to become pregnant during the time of the study
- Women of child-bearing potential (not surgically sterile or post-menopausal for at least 1 year) not using effective contraception
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
Placebo Comparator
Arm Label
FX005
Placebo 1 (Carrier)
Placebo 2 (Diluent)
Arm Description
Outcomes
Primary Outcome Measures
Change from baseline in the WOMAC A score (pain subscale)
Secondary Outcome Measures
Change from baseline in WOMAC A score (pain subscale)
Change from baseline for WOMAC A score (pain subscale)
Change from baseline for WOMAC B score (stiffness subscale)
Change from baseline for WOMAC C score (function subscale)
Change from baseline for WOMAC A1 response (pain on walking)
Change from baseline for WOMAC A1 response (pain on walking)
Change from baseline for WOMAC total score
Change from baseline for ICOAP intermittent pain score
Change from baseline for ICOAP constant pain score
Change from baseline for ICOAP total score
Percent of responders according to the OMERACT-OARSI (Outcome Measures in Rheumatoid Arthritis Clinical Trials-Osteoarthritis Research Society International) criteria
Change in patient's global assessment score
Change in clinical observer's global assessment score
Average weekly consumption of analgesic medications
Incidence of treatment emergent adverse events
Full Information
NCT ID
NCT01291914
First Posted
February 4, 2011
Last Updated
February 22, 2013
Sponsor
Flexion Therapeutics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01291914
Brief Title
Study of FX005 for the Treatment of Pain in Patients With Osteoarthritis of the Knee
Official Title
A Double-Blind, Randomized,Placebo-Controlled, Two-Phase Study (a Single Ascending Dose Phase Followed by a Proof of Concept Phase) to Assess the Safety, Efficacy and Pharmacokinetics of FX005 for the Treatment of Pain in Osteoarthritis of the Knee
Study Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Flexion Therapeutics, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate the safety, efficacy and pharmacokinetics of FX005 for the treatment of pain in patients with osteoarthritis of the knee.
Detailed Description
The objectives of the study are to assess FX005, as compared to placebo control, for:
Safety and tolerability
Analgesic effect
Pharmacokinetics
Analgesic effect will be assessed using the Western Ontario & McMaster University Osteoarthritis Index (WOMAC), the Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP) questionnaire, and patient and clinical observer global assessments.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
Osteoarthritis, knee, intra-articular, safety, efficacy, pharmacokinetics, pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
140 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FX005
Arm Type
Experimental
Arm Title
Placebo 1 (Carrier)
Arm Type
Placebo Comparator
Arm Title
Placebo 2 (Diluent)
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
FX005
Intervention Description
Single Ascending Dose (SAD) Phase Cohorts: 1, 10 or 45 mg intra-articular injection; Proof of Concept Phase: Maximum, well-tolerated dose intra-articular injection (determined during SAD Phase)
Intervention Type
Drug
Intervention Name(s)
Placebo 1 (Carrier)
Intervention Description
Single intra-articular injection
Intervention Type
Drug
Intervention Name(s)
Placebo 2 (Diluent)
Intervention Description
Single intra-articular injection
Primary Outcome Measure Information:
Title
Change from baseline in the WOMAC A score (pain subscale)
Time Frame
at 4 weeks post treatment
Secondary Outcome Measure Information:
Title
Change from baseline in WOMAC A score (pain subscale)
Time Frame
over 4, 8 and 12 weeks post treatment
Title
Change from baseline for WOMAC A score (pain subscale)
Time Frame
at 2, 8 and 12 weeks post treatment
Title
Change from baseline for WOMAC B score (stiffness subscale)
Time Frame
at 2, 4, 8 and 12 weeks post treatment
Title
Change from baseline for WOMAC C score (function subscale)
Time Frame
at 2, 4, 8 and 12 weeks post treatment
Title
Change from baseline for WOMAC A1 response (pain on walking)
Time Frame
at 2, 4, 8 and 12 weeks post treatment
Title
Change from baseline for WOMAC A1 response (pain on walking)
Time Frame
over 4, 8 and 12 weeks post treatment
Title
Change from baseline for WOMAC total score
Time Frame
at 2, 4, 8 and 12 weeks post treatment
Title
Change from baseline for ICOAP intermittent pain score
Time Frame
at 2, 4, 8 and 12 weeks post treatment
Title
Change from baseline for ICOAP constant pain score
Time Frame
at 2, 4, 8 and 12 weeks post treatment
Title
Change from baseline for ICOAP total score
Time Frame
at 2, 4, 8 and 12 weeks post treatment
Title
Percent of responders according to the OMERACT-OARSI (Outcome Measures in Rheumatoid Arthritis Clinical Trials-Osteoarthritis Research Society International) criteria
Time Frame
at 4, 8 and 12 weeks post treatment
Title
Change in patient's global assessment score
Time Frame
at 4, 8 and 12 weeks post treatment
Title
Change in clinical observer's global assessment score
Time Frame
at 4, 8 and 12 weeks post treatment
Title
Average weekly consumption of analgesic medications
Time Frame
over 12 weeks post treatment
Title
Incidence of treatment emergent adverse events
Time Frame
up to 12 weeks post treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female ≥40 years of age
Diagnosis of unilateral or bilateral osteoarthritis of the knee for at least 6 months; confirmation of osteoarthritis according to American College of Rheumatology Criteria (clinical and radiological)
Kellgren-Lawrence grades II or III
Mean score for the WOMAC A subscale (pain) between 2.0 and 3.5 for the index knee
Score of 2-3 for the WOMAC A1 score (pain on walking) for the index knee
Body mass index ≤ 40 kg/m2
Willingness to abstain from use of restricted medications during the study
Willingness and ability to comply with the study procedures and visit schedule
Exclusion Criteria:
Kellgren-Lawrence Grade 0, I or IV radiographic stage of the index knee
Clinically apparent tense effusion in index knee
Presence of surgical hardware or other foreign body in the index knee
Clinical signs and symptoms of active knee infection or crystal disease
Intra-articular corticosteroid within 3 months of Screening
Intra-articular hyaluronic acid within 6 months of Screening
Other intra-articular therapy within 3 months 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 malignancy or other serious, non-malignant, significant, acute or chronic medical (e.g.. uncontrolled diabetes) or active psychiatric illness
Skin breakdown at the knee where the injection would take place
Women who are pregnant, nursing or likely to become pregnant during the time of the study
Women of child-bearing potential (not surgically sterile or post-menopausal for at least 1 year) not using effective contraception
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neil Bodick, MD, PhD
Organizational Affiliation
Flexion Therapeutics, Inc.
Official's Role
Study Director
Facility Information:
City
Graz
Country
Austria
City
Wien
Country
Austria
City
Penticton
State/Province
British Columbia
Country
Canada
City
Newmarket
State/Province
Ontario
Country
Canada
City
Toronto
State/Province
Ontario
Country
Canada
City
Windsor
State/Province
Ontario
Country
Canada
City
Sainte-Foy
State/Province
Quebec
Country
Canada
City
Santiago de Compostela
State/Province
A Coruna
Country
Spain
City
Santander
State/Province
Cantabria
Country
Spain
City
A Coruna
Country
Spain
City
Barcelona
Country
Spain
City
Sevilla
Country
Spain
City
Southampton
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Study of FX005 for the Treatment of Pain in Patients With Osteoarthritis of the Knee
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