Osteoarthritis, HipPhase 3NCT03793010
Study to Evaluate the Efficacy and Safety of FX006 in Patients With Hip Osteoarthritis
A Phase 3 study testing FX006 and Normal saline in people with Osteoarthritis, Hip, run by Pacira Pharmaceuticals, Inc at 32 sites in United States.
Trial summary
This is a two-part, multi-center, randomized, double-blind, placebo-controlled, parallel-group study in patients with hip OA. Approximately 70 patients will be enrolled in Part I and approximately 440 patients will be enrolled in Part II of the study. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Osteoarthritis, Hip
- What is being tested?
- FX006 and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 32 sitesUnited States
- Study dates
- 12 Dec 2018to 7 Aug 2019
- Phase
- Phase 3
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions
- Patients 40 to 80 years of age, inclusive, on the day of randomization (Day 1)
- Body Mass Index (BMI) ≤ 40 kg/m2
- Symptoms associated with OA of the index hip for ≥ 3 months prior to Screening visit
- Currently meet the American College of Radiology (ACR) Criteria (clinical and radiological) for OA of the index hip
- Kellgren-Lawrence (KL) Grade 2 or 3 in the index hip as confirmed by X-ray during Screening visit (centrally read)
Show all 9Show fewer
- Qualifying mean score on the WOMAC A and C (0-10 NRS scale)
- Agree to maintain the similar activity level throughout the study
- Willingness to abstain from use of restricted medications
Who cannot join
- Patients who cannot washout of prohibited medications
- Diagnosed as secondary OA in the index hip including but not limited to articular fracture, major dysplasia or congenital abnormality, osteochondritis dissecans, acromegaly, ochronosis, hemochromatosis, Wilson's disease, or primary osteochondromatosis, etc.
- Ipsilateral chronic knee pain
- Sciatica
- Atrophic osteoarthritis, femoral head necrosis and/or collapse, or subchondral bone insufficiency fracture in the index hip joint determined via central reading
- Current or history of infection in the index hip (e.g. osteomyelitis) or current skin infection at injection site
Show all 18Show fewer
- Trauma or surgeries (e.g., arthroscopy, knee surgery) of lower limbs within 52 weeks with sequelae, etc.
- History or current evidence of reactive arthritis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or arthritis associated with inflammatory bowel disease, systemic lupus erythematosus or other autoimmune diseases
- Any planned surgeries in the lower limbs during the study period, or any other surgery during the study period that would require use of a restricted medication
- Presence of surgical hardware or other foreign body in the index hip
- Planned/anticipated surgery of the index hip or any other surgery that would require use of a restricted medication during the study period
- IA corticosteroid of any joint within 3 months of Screening visit (investigational or marketed, including FX006)
- IA treatment of index hip with any of the following agents within 6 months of Screening: any biologic agent or hyaluronic acid (investigational or marketed)
- IV or IM corticosteroids (investigational or marketed) within 3 months of Screening
- Oral corticosteroids (investigational or marketed) within 1 month of Screening
- Inhaled, intranasal or topical corticosteroids (investigational or marketed) within 2 weeks of Screening visit
- Planned or expected changes to lifestyle with regard to physical activity, physical therapy, acupuncture, transcutaneous electrical nerve stimulation (TENS), or bracing within 1 month prior to Screening and changes throughout the duration of the study
- Women of child-bearing potential (not surgically sterile or post-menopausal for at least 1 year as documented in medical history) not using a highly effective method or who are pregnant or nursing
Trial locations and contacts
32 sites in 1 country.
32 sites in 1 country
United States32 sites
University Orthopedics Center
Altoona, Pennsylvania, 16602
Northwest Clinical Research Center
Bellevue, Washington, 98007
Injury Care Research, LLC
Boise, Idaho, 83713
Hope Clinical Research
Canoga Park, California, 91303
Clinical Trials of South Carolina
Charleston, South Carolina, 29406
Coastal Carolina Research Center
Charleston, South Carolina, 29406
Charlottesville Medical Research
Charlottesville, Virginia, 22911
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
Tampa Bay Medical Research
Clearwater, Florida, 33761
Spectrum Medical, Inc.
Danville, Virginia, 24541
Florida Research Associates, LLC
DeLand, Florida, 32720
Mountain View Clinical Research, Inc.
Denver, Colorado, 80209
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
TriWest Research Associates, LLC
El Cajon, California, 92020
Drug Trials America
Hartsdale, New York, 10530
BioSolutions Clinical Research Center
La Mesa, California, 91942
Excel Clinical Research
Las Vegas, Nevada, 89109
Advanced Research for Health Improvement
Naples, Florida, 34102
Medallion Clinical Research Institute, LLC
Naples, Florida, 34102
Better Health Clinical Research, Inc
Newnan, Georgia, 30265
Heartland Research Associates
Newton, Kansas, 67114
Oviedo Medical Research
Oviedo, Florida, 32765
Arizona Research Center
Phoenix, Arizona, 85053
Progressive Medical Research
Port Orange, Florida, 32127
M3 Wake Research, Inc.
Raleigh, North Carolina, 27612
Wasatch Clinical Research, LLC
Salt Lake City, Utah, 84107
Artemis Institute for Clinical Research
San Diego, California, 92103
Precision Clinical Research, LLC
Sunrise, Florida, 33351
Noble Clinical Research
Tucson, Arizona, 85704
Chase Medical Research, LLC
Waterbury, Connecticut, 06708
PMG Research of Wilmington
Wilmington, North Carolina, 28401
National Pain Research Institute
Winter Park, Florida, 32789
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of FX006 in Patients With Hip Osteoarthritis
This is a two-part, multi-center, randomized, double-blind, placebo-controlled, parallel-group study in patients with hip OA. Approximately 70 patients will be enrolled in Part I and approximately 440 patients will be enrolled in Part II of the study. In each part, patients will be randomized to one of two treatment groups (1:1) and treated with a single IA injection of either 32 mg FX006 or normal saline.
Read the detailed description
This is a two-part, multi-center, randomized, double-blind, placebo-controlled, parallel-group study in patients with hip OA. Approximately 70 patients will be enrolled in Part I and approximately 440 patients will be enrolled in Part II of the study. In each part, patients will be randomized to one of two treatment groups (1:1) and treated with a single IA injection of either 32 mg FX006 or normal saline.
FX006 or saline placebo will be administered as a single IA injection with a 12-week follow-up period in the double-blind phase.
Patients participating in Part I of the study will be treated with a single IA injection of either 32 mg FX006 or normal saline and will return for follow up visits at Weeks 12, 16, 20, and 24. The patients will be discontinued at the time of notification by the Investigator.
Patients participating in Part II of the study will be treated with a single IA injection of either 32 mg FX006 or normal saline and will return for follow up visits at Weeks 12, 16, 20, and 24.
Patients participating in Part II of the study that are not clinically indicated for a second injection at Week 12 will return to the clinic at Weeks 16, 20, and 24 and will receive an open-label injection of FX006 at the first evaluation where the patient has been determined to meet all criteria. Patients will then return for follow-up visits every 4 weeks for 12 weeks post second injection and will complete the study 12 weeks post second injection (e.g., Week 24, 28, 32, or 36 depending on when the patient receives the open-label injection).
Patients participating in Part II of the study who are not eligible for a second injection after evaluation at Weeks 12, 16, 20, and 24 will complete the study at the Week 24 visit and complete the End of Study (EOS) assessments.
- Conditions
- Osteoarthritis, Hip
- Being tested
- FX006, Normal saline
- Keywords
- Osteoarthritis, Hip, Pain, Intra-articular, Injection
- Medical subject headings
- Osteoarthritis, Hip, Osteoarthritis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FX006Drug
Single Intra-articular injection
Normal salineDrug
Single Intra-articular injection
| Study group | Role | What they receive |
|---|---|---|
| FX006 | Experimental | FX006 32mg Receives: Drug: FX006 |
| Normal Saline | Placebo comparator | Normal Saline Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in WOMAC A (Pain) Score at Week 12
The change from baseline on the average Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A (pain) score at Week 12. The average WOMAC A score is calculated by taking the average of five questions with a range from 0 (no pain) to 10 (extreme pain).
Measured: Baseline and Week 12
Secondary outcomes (2)
Change in WOMAC C (Function) Score at Week 12
Change from Baseline on the WOMAC C (function) score at Week 12. The average WOMAC C score is calculated by taking the average of seventeen questions with a range from 0 (no difficulty) to 10 (extreme difficulty).
Measured: Baseline and Week 12
PGIC Score at Week 12
PGIC (Patient Global Impression of Change) at Week 12. The PGIC score has a range from 1(very much improved) to 7 (very much worse) and indicates the overall status of the patient since baseline.
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2019
- Study start12 Dec 2018
- Primary completion7 Aug 2019
- Study completion7 Aug 2019
Why it stopped: By Sponsor due to occurrences of incomplete study drug administration
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, HipStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, Double-blind, Placebo-controlled, Parallel-group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pacira Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Scott Kelley, MD, Study director, Pacira Pharmaceuticals, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03793010
- Sponsor's protocol ID
- FX006-2018-015
- Status last verified
- Jan 2024
- First submitted
- 2 Jan 2019
- Last updated
- 24 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- 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 Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of FX006 in Patients With Hip Osteoarthritis
- ClinicalTrials.gov ID
- NCT03793010
- Acronym / sponsor ID
- FX006-2018-015
- Conditions
- Osteoarthritis, Hip
- Keywords
- Osteoarthritis, Hip, Pain, Intra-articular, Injection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: By Sponsor due to occurrences of incomplete study drug administration
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Pacira Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- 12 Dec 2018 (actual)
- Primary completion
- 7 Aug 2019 (actual)
- Study completion
- 7 Aug 2019 (actual)
- First posted
- 4 Jan 2019 (actual)
- Results
- Posted 14 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a two-part, multi-center, randomized, double-blind, placebo-controlled, parallel-group study in patients with hip OA. Approximately 70 patients will be enrolled in Part I and approximately 440 patients will be enrolled in Part II of the study. In each part, patients will be randomized to one of two treatment groups (1:1) and treated with a single IA injection of either 32 mg FX006 or normal saline.
Detailed description
This is a two-part, multi-center, randomized, double-blind, placebo-controlled, parallel-group study in patients with hip OA. Approximately 70 patients will be enrolled in Part I and approximately 440 patients will be enrolled in Part II of the study. In each part, patients will be randomized to one of two treatment groups (1:1) and treated with a single IA injection of either 32 mg FX006 or normal saline.
FX006 or saline placebo will be administered as a single IA injection with a 12-week follow-up period in the double-blind phase.
Patients participating in Part I of the study will be treated with a single IA injection of either 32 mg FX006 or normal saline and will return for follow up visits at Weeks 12, 16, 20, and 24. The patients will be discontinued at the time of notification by the Investigator.
Patients participating in Part II of the study will be treated with a single IA injection of either 32 mg FX006 or normal saline and will return for follow up visits at Weeks 12, 16, 20, and 24.
Patients participating in Part II of the study that are not clinically indicated for a second injection at Week 12 will return to the clinic at Weeks 16, 20, and 24 and will receive an open-label injection of FX006 at the first evaluation where the patient has been determined to meet all criteria. Patients will then return for follow-up visits every 4 weeks for 12 weeks post second injection and will complete the study 12 weeks post second injection (e.g., Week 24, 28, 32, or 36 depending on when the patient receives the open-label injection).
Patients participating in Part II of the study who are not eligible for a second injection after evaluation at Weeks 12, 16, 20, and 24 will complete the study at the Week 24 visit and complete the End of Study (EOS) assessments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, Double-blind, Placebo-controlled, Parallel-group
| Arm | Type | Receives |
|---|---|---|
| FX006 | Experimental | Drug: FX006FX006 32mg |
| Normal Saline | Placebo comparator | Drug: Normal salineNormal Saline |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions
- Patients 40 to 80 years of age, inclusive, on the day of randomization (Day 1)
- Body Mass Index (BMI) ≤ 40 kg/m2
- Symptoms associated with OA of the index hip for ≥ 3 months prior to Screening visit
- Currently meet the American College of Radiology (ACR) Criteria (clinical and radiological) for OA of the index hip
Key exclusion criteria (18 listed)
- Patients who cannot washout of prohibited medications
- Diagnosed as secondary OA in the index hip including but not limited to articular fracture, major dysplasia or congenital abnormality, osteochondritis dissecans, acromegaly, ochronosis, hemochromatosis, Wilson's disease, or primary osteochondromatosis, etc.
- Ipsilateral chronic knee pain
- Sciatica
- Atrophic osteoarthritis, femoral head necrosis and/or collapse, or subchondral bone insufficiency fracture in the index hip joint determined via central reading
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 Intra-articular injection | Drug | FX006 |
| Normal salineSingle Intra-articular injection | Drug | Normal Saline |
Primary outcome
Change in WOMAC A (Pain) Score at Week 12
Time frame: Baseline and Week 12
The change from baseline on the average Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A (pain) score at Week 12. The average WOMAC A score is calculated by taking the average of five questions with a range from 0 (no pain) to 10 (extreme pain).
2 secondary outcomes
Change in WOMAC C (Function) Score at Week 12
Time frame: Baseline and Week 12
PGIC Score at Week 12
Time frame: 12 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.
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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.
Scott Kelley, MD study director
Pacira Pharmaceuticals, Inc
32 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing FX006 and Normal saline in people with Osteoarthritis, Hip, run by Pacira Pharmaceuticals, Inc at 32 sites in United States.
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 9 inclusion and 18 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: stopped early, 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 32 sites in 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. 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 phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 14 Sep 2020). 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 in WOMAC A (Pain) Score at Week 12 (time frame: Baseline and Week 12). 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.