Osteoarthritis of the KneePhase 2NCT01487161
Study of FX006 in Patients With Osteoarthritis of the Knee
A Phase 2 study testing FX006 and TCA IR in people with Osteoarthritis of the Knee, run by Pacira Pharmaceuticals, Inc at 21 sites in 3 countries.
Trial summary
The purpose of this study was to evaluate the safety, efficacy and pharmacokinetics of FX006 in patients with osteoarthritis of the knee. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Osteoarthritis of the Knee
- What is being tested?
- FX006 and TCA IR
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 229 participants
- Where
- 21 sitesin 3 countries
- Study dates
- Jun 2012to Apr 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
- 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 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
Trial locations and contacts
21 sites in 3 countries.
21 sites in 3 countries
Canada10 sites
Study site
Etobicoke, Ontario
Study site
Halifax, Nova Scotia
Study site
Montreal, Quebec
Study site
Newmarket, Ontario
Study site
Saint Catherine's, Ontario
Study site
Sainte-Foy, Quebec
Study site
Sarnia, Ontario
Study site
Thornhill, Ontario
Study site
Waterloo, Ontario
Study site
Windsor, Ontario
Australia9 sites
Study site
Broadmeadow, New South Wales
Study site
Clayton, Victoria
Study site
Kippa-Ring, Queensland
Study site
Kogarah, New South Wales
Study site
Malvern East, Victoria
Study site
Maroochydore, Queensland
Study site
Sherwood, Queensland
Study site
St Leonards, New South Wales
Study site
Wollongong, New South Wales
United States2 sites
Study site
Duncansville, Pennsylvania, 16635
Study site
Tucson, Arizona, 85704
About this study
Official 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
The purpose of this study was to evaluate the safety, efficacy and pharmacokinetics of FX006 in patients with osteoarthritis of the knee.
Read the detailed description
Study FX006-2011-001 was a multi-center, randomized, double-blind, active comparator, parallel-group, single-dose study designed to assess the magnitude and duration of pain relief of three doses (10, 40, and 60 mg) of FX006, an extended-release formulation of TCA, relative to commercially-available TCA IR.
The general tolerability of a single injection of FX006 also was assessed.
Secondary objectives included exploration of the effect of FX006 on functional improvement, responder status, time to onset of pain relief, global impressions of change, and consumption of analgesic medications and evaluation of the PK profile of single injection of the three dose levels of FX006.
The study was planned to be conducted in up to 224 male and female patients ≥40 years of age with OA of the knee enrolled at 22 study centers in the US, Australia, and Canada.
- Conditions
- Osteoarthritis of the Knee
- Being tested
- FX006, TCA IR
- Keywords
- osteoarthritis, knee, pain, corticosteroid, intra-articular, injection
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FX006Drug
Single 3 mL intra-articular injection
TCA IRDrug
Also called Kenalog®-40 Injection, Kenacort-A 40, Triamcinolone Acetonide Crystalline Suspension (TAcs)
Single 1 mL intra-articular injection
| Study group | Role | What they receive |
|---|---|---|
| FX006 10 mg | Experimental | Single 3 mL intra-articular (IA) injection Extended-Release Formulation Receives: Drug: FX006 |
| FX006 40 mg | Experimental | Single 3 mL intra-articular (IA) injection Extended-Release Formulation Receives: Drug: FX006 |
| FX006 60 mg | Experimental | Single 3mL intra-articular (IA) injection Extended-Release Formulation Receives: Drug: FX006 |
| TCA IR 40 mg | Active comparator | Single 1 mL intra-articular (IA) injection Immediate-Release Triamcinolone Acetonide Receives: Drug: TCA IR |
What is being measured
The primary outcome is the main question the study is designed to answer.
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."
Measured: 8 weeks
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."
Measured: 10 weeks
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."
Measured: 12 weeks
Secondary outcomes (13)
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."
Measured: Weeks 8, 10 and 12
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."
Measured: Weeks 1-7 and Week 9 and 11
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.
Measured: 8 weeks
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.
Measured: 8 weeks
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.
Measured: 8 weeks
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.
Measured: 8 weeks
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.
Measured: 8 weeks
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."
Measured: 8 weeks
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."
Measured: 8 weeks
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."
Measured: 8 weeks
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.
Measured: Week 8
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.
Measured: 8 weeks
Average Weekly and Total Consumption of Rescue Medications Over 8 Weeks.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2011 (estimated)
- Study startJun 2012
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Osteoarthritis of the KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 229 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pacira Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Neil Bodick, MD, PhD, Study director, Flexion Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01487161
- Sponsor's protocol ID
- FX006-2011-001
- Status last verified
- Jan 2024
- First submitted
- 5 Dec 2011
- Last updated
- 24 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT01487161
- Acronym / sponsor ID
- FX006-2011-001
- Conditions
- Osteoarthritis of the Knee
- Keywords
- osteoarthritis, knee, pain, corticosteroid, intra-articular, injection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 229 participants (actual)
- Lead sponsor
- Pacira Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 7 Dec 2011 (estimated)
- Results
- Posted 12 Jan 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to evaluate the safety, efficacy and pharmacokinetics of FX006 in patients with osteoarthritis of the knee.
Detailed description
Study FX006-2011-001 was a multi-center, randomized, double-blind, active comparator, parallel-group, single-dose study designed to assess the magnitude and duration of pain relief of three doses (10, 40, and 60 mg) of FX006, an extended-release formulation of TCA, relative to commercially-available TCA IR.
The general tolerability of a single injection of FX006 also was assessed.
Secondary objectives included exploration of the effect of FX006 on functional improvement, responder status, time to onset of pain relief, global impressions of change, and consumption of analgesic medications and evaluation of the PK profile of single injection of the three dose levels of FX006.
The study was planned to be conducted in up to 224 male and female patients ≥40 years of age with OA of the knee enrolled at 22 study centers in the US, Australia, and Canada.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| FX006 10 mg | Experimental | Drug: FX006Single 3 mL intra-articular (IA) injection Extended-Release Formulation |
| FX006 40 mg | Experimental | Drug: FX006Single 3 mL intra-articular (IA) injection Extended-Release Formulation |
| FX006 60 mg | Experimental | Drug: FX006Single 3mL intra-articular (IA) injection Extended-Release Formulation |
| TCA IR 40 mg | Active comparator | Drug: TCA IRSingle 1 mL intra-articular (IA) injection Immediate-Release Triamcinolone Acetonide |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FX006Single 3 mL intra-articular injection | Drug | FX006 10 mg, FX006 40 mg, FX006 60 mg |
| TCA IRAlso: Kenalog®-40 Injection, Kenacort-A 40, Triamcinolone Acetonide Crystalline Suspension (TAcs)Single 1 mL intra-articular injection | Drug | TCA IR 40 mg |
Primary outcome
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
Time frame: 8 weeks
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."
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
Time frame: 10 weeks
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."
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
Time frame: 12 weeks
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."
13 secondary outcomes
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
Time frame: Weeks 8, 10 and 12
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.
Time frame: Weeks 1-7 and Week 9 and 11
WOMAC A (Pain Subscale) Change From Baseline at Week 8
Time frame: 8 weeks
WOMAC A1 (Pain on Walking Question) Change From Baseline at Week 8
Time frame: 8 weeks
WOMAC B (Stiffness Subscale) Change From Baseline at Week 8
Time frame: 8 weeks
WOMAC C (Function Subscale) Change From Baseline at Week 8
Time frame: 8 weeks
Percent of Responders According to OMERACT-OARSI Criteria at Week 8
Time frame: 8 weeks
Responder Status as Defined by the Proportion of Patients Achieving >50% Improvement From Baseline in the Mean Daily Pain Intensity Scores at Week 8
Time frame: 8 weeks
Responder Status as Defined by the Proportion of Patients Achieving >30% Improvement From Baseline in the Mean Daily Pain Intensity Scores at Week 8
Time frame: 8 weeks
Responder Status as Defined by the Proportion of Patients Achieving >20% Improvement From Baseline in the Mean Daily Pain Intensity Scores at Week 8
Time frame: 8 weeks
Patient Global Impression of Change Scores at Week 8
Time frame: Week 8
Clinical Global Impression of Change Scores at Week 8
Time frame: 8 weeks
Average Weekly and Total Consumption of Rescue Medications Over 8 Weeks.
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Journal of Bone \& Joint Surgery - American Volume: 3 June 2015 - Volume 97 - Issue 11 - p 877-888Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neil Bodick, MD, PhD study director
Flexion Therapeutics
21 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FX006 and TCA IR in people with Osteoarthritis of the Knee, run by Pacira Pharmaceuticals, Inc at 21 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in Canada, Australia, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2024.