Osteoarthritis, KneePhase 1/2NCT01291914
Study of FX005 for the Treatment of Pain in Patients With Osteoarthritis of the Knee
A Phase 1/2 study testing FX005 in people with Osteoarthritis, Knee, run by Pacira Pharmaceuticals, Inc at 13 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- FX005
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 13 sitesin 4 countries
- Study dates
- Dec 2010to Mar 2012
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
13 sites in 4 countries.
13 sites in 4 countries
Canada5 sites
Study site
Newmarket, Ontario
Study site
Penticton, British Columbia
Study site
Sainte-Foy, Quebec
Study site
Toronto, Ontario
Study site
Windsor, Ontario
Spain5 sites
Study site
A Coruña
Study site
Barcelona
Study site
Santander, Cantabria
Study site
Santiago de Compostela, A Coruna
Study site
Seville
About this study
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
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.
Read the 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.
- Conditions
- Osteoarthritis, Knee
- Being tested
- FX005, Placebo 1 (Carrier), Placebo 2 (Diluent)
- Keywords
- Osteoarthritis, knee, intra-articular, safety, efficacy, pharmacokinetics, pain
- 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.
FX005Drug
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)
Placebo 1 (Carrier)Drug
Single intra-articular injection
Placebo 2 (Diluent)Drug
Single intra-articular injection
| Study group | Role | What they receive |
|---|---|---|
| FX005 | Experimental | Not described Receives: Drug: FX005 |
| Placebo 1 (Carrier) | Placebo comparator | Not described Receives: Drug: Placebo 1 (Carrier) |
| Placebo 2 (Diluent) | Placebo comparator | Not described Receives: Drug: Placebo 2 (Diluent) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the WOMAC A score (pain subscale)
Measured: at 4 weeks post treatment
Secondary outcomes (15)
Change from baseline in WOMAC A score (pain subscale)
Measured: over 4, 8 and 12 weeks post treatment
Change from baseline for WOMAC A score (pain subscale)
Measured: at 2, 8 and 12 weeks post treatment
Change from baseline for WOMAC B score (stiffness subscale)
Measured: at 2, 4, 8 and 12 weeks post treatment
Change from baseline for WOMAC C score (function subscale)
Measured: at 2, 4, 8 and 12 weeks post treatment
Change from baseline for WOMAC A1 response (pain on walking)
Measured: at 2, 4, 8 and 12 weeks post treatment
Change from baseline for WOMAC A1 response (pain on walking)
Measured: over 4, 8 and 12 weeks post treatment
Change from baseline for WOMAC total score
Measured: at 2, 4, 8 and 12 weeks post treatment
Change from baseline for ICOAP intermittent pain score
Measured: at 2, 4, 8 and 12 weeks post treatment
Change from baseline for ICOAP constant pain score
Measured: at 2, 4, 8 and 12 weeks post treatment
Change from baseline for ICOAP total score
Measured: at 2, 4, 8 and 12 weeks post treatment
Percent of responders according to the OMERACT-OARSI (Outcome Measures in Rheumatoid Arthritis Clinical Trials-Osteoarthritis Research Society International) criteria
Measured: at 4, 8 and 12 weeks post treatment
Change in patient's global assessment score
Measured: at 4, 8 and 12 weeks post treatment
Change in clinical observer's global assessment score
Measured: at 4, 8 and 12 weeks post treatment
Average weekly consumption of analgesic medications
Measured: over 12 weeks post treatment
Incidence of treatment emergent adverse events
Measured: up to 12 weeks post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2011 (estimated)
- Study startDec 2010
- Primary completionJan 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 140 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, Pacira Pharmaceuticals, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01291914
- Sponsor's protocol ID
- FX005-2010-001
- Status last verified
- Jan 2024
- First submitted
- 4 Feb 2011
- Last updated
- 24 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
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,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
- ClinicalTrials.gov ID
- NCT01291914
- Acronym / sponsor ID
- FX005-2010-001
- Conditions
- Osteoarthritis, Knee
- Keywords
- Osteoarthritis, knee, intra-articular, safety, efficacy, pharmacokinetics, pain
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Pacira Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Jan 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 9 Feb 2011 (estimated)
- Results
- Not posted in the source record
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| FX005 | Experimental | Drug: FX005 |
| Placebo 1 (Carrier) | Placebo comparator | Drug: Placebo 1 (Carrier) |
| Placebo 2 (Diluent) | Placebo comparator | Drug: Placebo 2 (Diluent) |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (13 listed)
- 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
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 |
|---|---|---|
| FX005Single 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) | Drug | FX005 |
| Placebo 1 (Carrier)Single intra-articular injection | Drug | Placebo 1 (Carrier) |
| Placebo 2 (Diluent)Single intra-articular injection | Drug | Placebo 2 (Diluent) |
Primary outcome
Change from baseline in the WOMAC A score (pain subscale)
Time frame: at 4 weeks post treatment
15 secondary outcomes
Change from baseline in WOMAC A score (pain subscale)
Time frame: over 4, 8 and 12 weeks post treatment
Change from baseline for WOMAC A score (pain subscale)
Time frame: at 2, 8 and 12 weeks post treatment
Change from baseline for WOMAC B score (stiffness subscale)
Time frame: at 2, 4, 8 and 12 weeks post treatment
Change from baseline for WOMAC C score (function subscale)
Time frame: at 2, 4, 8 and 12 weeks post treatment
Change from baseline for WOMAC A1 response (pain on walking)
Time frame: at 2, 4, 8 and 12 weeks post treatment
Change from baseline for WOMAC A1 response (pain on walking)
Time frame: over 4, 8 and 12 weeks post treatment
Change from baseline for WOMAC total score
Time frame: at 2, 4, 8 and 12 weeks post treatment
Change from baseline for ICOAP intermittent pain score
Time frame: at 2, 4, 8 and 12 weeks post treatment
Change from baseline for ICOAP constant pain score
Time frame: at 2, 4, 8 and 12 weeks post treatment
Change from baseline for ICOAP total score
Time frame: at 2, 4, 8 and 12 weeks post treatment
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
Change in patient's global assessment score
Time frame: at 4, 8 and 12 weeks post treatment
Change in clinical observer's global assessment score
Time frame: at 4, 8 and 12 weeks post treatment
Average weekly consumption of analgesic medications
Time frame: over 12 weeks post treatment
Incidence of treatment emergent adverse events
Time frame: up to 12 weeks post treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2024.
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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
Pacira Pharmaceuticals, Inc
13 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing FX005 in people with Osteoarthritis, Knee, run by Pacira Pharmaceuticals, Inc at 13 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. 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 13 sites in Canada, Spain, Austria, United Kingdom. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 in the WOMAC A score (pain subscale) (time frame: at 4 weeks post treatment). 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.