Osteoarthritis of the ShoulderPhase 2NCT04160091
Study to Evaluate the Efficacy and Safety of FX006 in Patients With Glenohumeral Osteoarthritis or Shoulder Adhesive Capsulitis
A Phase 2 study testing FX006 and Normal Saline in people with Osteoarthritis of the Shoulder and Adhesive Capsulitis, run by Pacira Pharmaceuticals, Inc at 27 sites in United States.
Trial summary
This is a double-blind study to evaluate the efficacy and safety of FX006 in patients with glenohumeral osteoarthritis (OA) or shoulder adhesive capsulitis (AC). Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Osteoarthritis of the Shoulder, Adhesive Capsulitis
- 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
- 19 participants
- Where
- 27 sitesUnited States
- Study dates
- 7 Nov 2019to 15 Jun 2020
- 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 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Glenohumeral OA:
- Male or female, 35 to 80 years of age, inclusive, on the day of consent.
- Painful symptoms associated with OA of the index glenohumeral joint for ≤3 months prior to the Screening Visit.
- Grade 2 or 3 OA in the index glenohumeral joint based on the Samilson-Prieto classification system as confirmed by X-ray (axillary view and true anterior-posterior view) taken at the Screening Visit.
- Shoulder AC:
- Male or female, 35 to 80 years of age, inclusive, on the day of consent.
Show all 18Show fewer
- Pain associated with AC of the index joint for ≥1 month but ≤ 6 months prior to the Screening Visit.
- Limitations on both active and passive ROM ≥25% in at least 2 directions (e.g., forward flexion, abduction, and internal and external rotation assessed in a standardized protocol) compared with the contralateral shoulder or with normal values.
- No X-ray evidence of OA of the index shoulder (axillary view and true anterior-posterior view) at the Screening Visit.
- Agrees to complete a standardized, protocol-specified shoulder Home Exercise Program (HEP) starting 3 days after injection until the End of Study (EOS) Visit.
- Both:
- Written consent to participate in the study
- Willing and able to comply with the study procedures and visit schedules and able to follow verbal and written instructions
- (BMI) ≤ 40 kg/m2
- Average daily mean shoulder pain with movement score ≥5.0 and ≤9.0 in the index shoulder (0 to 10 NRS) using the average daily ratings for at least 5 out of the 7 days prior to Day 1.
- Shoulder pain present >15 days in the month prior to the Screening Visit
- Willing to complete a washout of protocol-specified excluded medications 7 days prior to Day 1 and abstain from use of protocol-specified excluded medications throughout the study
- Willing to abstain from nonpharmacological therapies for the index joint for 2 weeks prior to Day 1 and throughout the study.
Who cannot join
- Has both glenohumeral OA and shoulder AC
- Has bilateral AC
- Has bilateral glenohumeral OA with glenohumeral OA pain of the shoulder contralateral to the index shoulder >3.0 (0 to 10 NRS) within 1 month prior to the Screening Visit
- Has a history of arthritis in other joints of the index shoulder (as confirmed by medical history and physical exam)
- Has a history or suspicion of full thickness rotator cuff tear in the index shoulder within 6 months of the Screening Visit
- Has symptomatic partial rotator cuff tear, tendinopathy, tendonitis, or bursitis in the index shoulder within 6 months of the Screening Visit
Show all 35Show fewer
- Has a subchondral bone insufficiency fracture or humeral head necrosis/collapse in the index shoulder
- Shoulder AC patients only: Has a history of shoulder surgery or radiotherapy
- Glenohumeral OA patients only: Has a previous shoulder injury with functional limitation ≥1 month or surgery within 52 weeks of the Screening Visit
- Has an index shoulder with major dysplasia or congenital abnormality, osteochondritis dissecans, acromegaly, ochronosis, hemochromatosis, Wilson's disease, or primary osteochondromatosis, or a history of avascular necrosis with secondary OA
- Has current or history of infection in the index shoulder or current skin infection at injection site
- Has a concurrent chronic pain condition with a pain score >3.0 (0 to 10 NRS) within 1 month prior to the Screening Visit
- Has a history or current evidence of reactive arthritis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or arthritis associated with inflammatory bowel disease, systemic lupus erythematosus, calcium pyrophosphate dihydrate crystal deposition disease (CPPD), or other autoimmune diseases
- Has any planned surgeries in the upper limbs during the study or any other surgery during the study that would require use of a restricted medication
- Has surgical hardware or other foreign body present in the index shoulder
- Has received an IA corticosteroid of any joint within 3 months of the Screening Visit
- Has received an IA treatment of the index shoulder with any of the following agents within 6 months of the Screening Visit
- Has received intravenous (IV), intrabursal, intratendinous, intramuscular (IM) or epidural corticosteroids within 3 months of the Screening Visit
- Has received oral corticosteroids within 1 month of the Screening Visit
- Has received inhaled, intranasal, or topical corticosteroids within 2 weeks of the Screening Visit
- Has had significant changes to lifestyle with regard to physical activity and lifestyle within 1 month of the Screening Visit or any planned changes throughout the duration of the study
- Has known hypersensitivity to TA or PLGA
- Has laboratory evidence of infection with (HIV), a positive test for hepatitis B surface antigen (HBsAg), or positive serology for hepatitis C virus (HCV) with positive test for HCV ribonucleic acid
- Has an electrocardiogram (ECG) abnormality
- Has uncontrolled diabetes as indicated by a hemoglobin A1c of >8% (>59 mmol/mol).
- Has a history of sarcoidosis or amyloidosis
- Has a history of or active Cushing's syndrome
- Has used chemotherapeutic agents, immunomodulators, or immunosuppressants within 5 years of the Screening Visit
- Has current or history of malignancy within 5 years prior to the Screening Visit, except for basal or squamous cell carcinoma of the skin or cervical carcinoma in situ that has been treated successfully.
- Has active substance use disorder or history of substance use disorder within 12 months prior to the Screening Visit
- Has received a live or live attenuated vaccine within 3 months of the Screening Visit
- Has used any other investigational drug, biologic, or device within 3 months of the Screening Visit
- Has any infection requiring IV antibiotics 4 weeks prior to Day 1 or oral antibiotics 2 weeks prior to Day 1
- Has a contraindication to the use of acetaminophen
- Is a female that is pregnant or nursing or plans to become pregnant during the study; or is a male who plans to inseminate a partner or donate sperm during the study
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
United States27 sites
University Orthopedics Center
Altoona, Pennsylvania, 16602
Texas Orthopedic Specialists
Bedford, Texas, 76021
Hassman Research Institute
Berlin, New Jersey, 08009
Central Research Associates
Birmingham, Alabama, 35205
Alabama Clinical Therapeutics, LLC
Birmingham, Alabama, 35235
Affinity Orthopedic Specialists
Birmingham, Alabama, 35243
Coastal Orthopaedics and Sports Medicine
Bradenton, Florida, 34209
South Lake Pain Institute
Clermont, Florida, 34711
Spectrum Medical, Inc.
Danville, Virginia, 24541
Mountain View Clinical Research Center
Denver, Colorado, 80209
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
M3 Emerging Medical Research
Durham, North Carolina, 22704
TriWest Research Associates
El Cajon, California, 92020
CORE Orthopedic Medical Center
Encinitas, California, 92924
Universal Axon Clinical Research
Homestead, Florida, 33030
Centex Studies, Inc.
Houston, Texas, 77058
BioSolutions Clinical Research Center
La Mesa, California, 91924
Precision Clinical Research
Lauderdale Lakes, Florida, 33319
Infinite Clinical Research
Miami, Florida, 33133
Coastal Clinical Research, Inc.
Mobile, Alabama, 36608
Better Health Clinical Research, Inc.
Newnan, Georgia, 30265
Jewitt Orthopedic Center
Orlando, Florida, 32822
Arizona Research Center
Phoenix, Arizona, 85053
Gulfcoast Research Institute
Sarasota, Florida, 34232
Tucson Orthopaedic Institute
Tucson, Arizona, 85712
Arthritis and Rheumatism Associates PC
Wheaton, Maryland, 20902
Professional Research Network of Kansas, LLC
Wichita, Kansas, 67205
About this study
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of FX006 in Patients With Glenohumeral Osteoarthritis or Shoulder Adhesive Capsulitis (RANGE)
This is a double-blind study to evaluate the efficacy and safety of FX006 in patients with glenohumeral osteoarthritis (OA) or shoulder adhesive capsulitis (AC).
Read the detailed description
This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-group study in separate cohorts of patients with a documented history of either glenohumeral OA or shoulder AC. Glenohumeral OA and shoulder AC patients will be randomized to receive a single intra-articular injection of either FX006 or placebo (saline) in a 1:1 ratio to the index shoulder with a 24-week Treatment Evaluation Period. Glenohumeral OA patients will be stratified by Baseline average daily shoulder pain with movement score according to the following classifications: 5.0 to <7.0 or ≥7.0 to 9.0 (0 to 10 numeric rating scale [NRS]). Shoulder AC patients will be stratified by Baseline average daily shoulder pain with movement score according to the following classifications: 5.0 to <7.0 or ≥7.0 to 9.0 (0 to 10 NRS), and by pain duration since onset (1 to 3 months, inclusive, or >3 to ≤6 months). A Home Exercise Program will be implemented 3 days following injection for shoulder AC patients.
- Being tested
- FX006, Normal Saline
- Keywords
- Osteoarthritis, Adhesive Capsulitis, Shoulder, Pain, Intra-articular, Injection, Steroid
- Medical subject headings
- Bursitis, Osteoarthritis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FX006Drug
Also called Zilretta
Single intra-articular injection
Normal SalineDrug
Single intra-articular injection
| Study group | Role | What they receive |
|---|---|---|
| FX006 32mg in Glenohumeral OA Population | Experimental | Single intra-articular (IA) injection Receives: Drug: FX006 |
| Normal Saline in Glenohumeral OA Population | Placebo comparator | Single intra-articular (IA) injection Receives: Drug: Normal Saline |
| FX006 32mg in Adhesive Capsulitis Population | Experimental | Single intra-articular (IA) injection Receives: Drug: FX006 |
| Normal Saline in Adhesive Capsulitis Population | Placebo comparator | Single intra-articular (IA) injection Receives: Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Curve of the Change From Baseline in the Weekly Mean of the Daily Shoulder Pain With Movement
The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates "No pain" and 10 indicates "Worst possible pain."
Measured: Baseline to 8 weeks
Secondary outcomes (5)
Change From Baseline in the Weekly Mean of the Average Daily Shoulder Pain With Movement Score
The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates "No pain" and 10 indicates "Worst possible pain."
Measured: Baseline to 12 weeks
Change From Baseline in the SPADI Pain Subscale at Week 12
Shoulder Pain and Disability Index (SPADI) Pain scale is measured using 5 11-point NRS questions where 0 indicates "no pain" and 10 indicates "worst pain imaginable." The Pain and Disability Subscales are presented as a percentage of the total possible score. The Total SPADI score ranges from 0 (best) to 100 (worst) is computed by taking the means of the Pain and Disability Subscale scores.
Measured: Baseline to 12 weeks
Change From Baseline in the SPADI Disability Subscale at Week 12
Shoulder Pain and Disability Index (SPADI) Disability scale is measured using 8 11-point NRS questions where 0 indicates "no difficulty" and 10 indicates "so difficult it requires help." The Pain and Disability Subscales are presented as a percentage of the total possible score. The Total SPADI score ranges from 0 (best) to 100 (worst) is computed by taking the means of the Pain and Disability Subscale scores.
Measured: Baseline to 12 weeks
Patient Global Impression of Change (PGIC) Score at Week 12
PGIC is measured using a 7-point NRS where 1 indicates "very much improved" and 7 indicates "very much worse."
Measured: Baseline to 12 weeks
Change From Baseline in the Range of Motion (ROM) of Active External Rotation at Week 12
Measured using a goniometer which is a device that measures ROM joint angles
Measured: Baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2019
- Study start7 Nov 2019
- Primary completion15 Jun 2020
- Study completion15 Jun 2020
Why it stopped: The study was terminated prematurely due to the COVID-19 pandemic creating uncertainty impacting trial progress and costs.
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 ShoulderStudies 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
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pacira Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medpace, Inc.
- Responsible party
- Sponsor
- Investigators
- Scott Kelley, MD, Study director, Pacira Pharmaceuticals, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04160091
- Sponsor's protocol ID
- FX006-2018-016
- Status last verified
- Jan 2024
- First submitted
- 8 Nov 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 Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of FX006 in Patients With Glenohumeral Osteoarthritis or Shoulder Adhesive Capsulitis (RANGE)
- ClinicalTrials.gov ID
- NCT04160091
- Acronym / sponsor ID
- FX006-2018-016
- Keywords
- Osteoarthritis, Adhesive Capsulitis, Shoulder, Pain, Intra-articular, Injection, Steroid
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated prematurely due to the COVID-19 pandemic creating uncertainty impacting trial progress and costs.
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Pacira Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Collaborators
- Medpace, Inc.
- Study start
- 7 Nov 2019 (actual)
- Primary completion
- 15 Jun 2020 (actual)
- Study completion
- 15 Jun 2020 (actual)
- First posted
- 12 Nov 2019 (actual)
- Results
- Posted 30 Nov 2021
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 double-blind study to evaluate the efficacy and safety of FX006 in patients with glenohumeral osteoarthritis (OA) or shoulder adhesive capsulitis (AC).
Detailed description
This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-group study in separate cohorts of patients with a documented history of either glenohumeral OA or shoulder AC. Glenohumeral OA and shoulder AC patients will be randomized to receive a single intra-articular injection of either FX006 or placebo (saline) in a 1:1 ratio to the index shoulder with a 24-week Treatment Evaluation Period. Glenohumeral OA patients will be stratified by Baseline average daily shoulder pain with movement score according to the following classifications: 5.0 to <7.0 or ≥7.0 to 9.0 (0 to 10 numeric rating scale [NRS]). Shoulder AC patients will be stratified by Baseline average daily shoulder pain with movement score according to the following classifications: 5.0 to <7.0 or ≥7.0 to 9.0 (0 to 10 NRS), and by pain duration since onset (1 to 3 months, inclusive, or >3 to ≤6 months). A Home Exercise Program will be implemented 3 days following injection for shoulder AC patients.
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 32mg in Glenohumeral OA Population | Experimental | Drug: FX006Single intra-articular (IA) injection |
| Normal Saline in Glenohumeral OA Population | Placebo comparator | Drug: Normal SalineSingle intra-articular (IA) injection |
| FX006 32mg in Adhesive Capsulitis Population | Experimental | Drug: FX006Single intra-articular (IA) injection |
| Normal Saline in Adhesive Capsulitis Population | Placebo comparator | Drug: Normal SalineSingle intra-articular (IA) injection |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Male or female, 35 to 80 years of age, inclusive, on the day of consent.
- Painful symptoms associated with OA of the index glenohumeral joint for ≤3 months prior to the Screening Visit.
- Grade 2 or 3 OA in the index glenohumeral joint based on the Samilson-Prieto classification system as confirmed by X-ray (axillary view and true anterior-posterior view) taken at the Screening Visit.
- Male or female, 35 to 80 years of age, inclusive, on the day of consent.
- Pain associated with AC of the index joint for ≥1 month but ≤ 6 months prior to the Screening Visit.
Key exclusion criteria (35 listed)
- Has both glenohumeral OA and shoulder AC
- Has bilateral AC
- Has bilateral glenohumeral OA with glenohumeral OA pain of the shoulder contralateral to the index shoulder >3.0 (0 to 10 NRS) within 1 month prior to the Screening Visit
- Has a history of arthritis in other joints of the index shoulder (as confirmed by medical history and physical exam)
- Has a history or suspicion of full thickness rotator cuff tear in the index shoulder within 6 months of the Screening Visit
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 |
|---|---|---|
| FX006Also: ZilrettaSingle intra-articular injection | Drug | FX006 32mg in Adhesive Capsulitis Population, FX006 32mg in Glenohumeral OA Population |
| Normal SalineSingle intra-articular injection | Drug | Normal Saline in Adhesive Capsulitis Population, Normal Saline in Glenohumeral OA Population |
Primary outcome
Area Under the Curve of the Change From Baseline in the Weekly Mean of the Daily Shoulder Pain With Movement
Time frame: Baseline to 8 weeks
The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates "No pain" and 10 indicates "Worst possible pain."
5 secondary outcomes
Change From Baseline in the Weekly Mean of the Average Daily Shoulder Pain With Movement Score
Time frame: Baseline to 12 weeks
Change From Baseline in the SPADI Pain Subscale at Week 12
Time frame: Baseline to 12 weeks
Change From Baseline in the SPADI Disability Subscale at Week 12
Time frame: Baseline to 12 weeks
Patient Global Impression of Change (PGIC) Score at Week 12
Time frame: Baseline to 12 weeks
Change From Baseline in the Range of Motion (ROM) of Active External Rotation at Week 12
Time frame: Baseline to 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.
Related trials for Osteoarthritis of the Shoulder
Not yet recruiting
Comparison of High-Intensity and Conventional Physical Therapy in Musculoskeletal Disorders
Low Back Pain, Radicular Syndrome
Recruiting
SMR Stemless Reverse vs SMR Reverse Shoulder System
Arthroplasty, Replacement
Not yet recruitingObservational study
Clinical Validation of SMARTDIAGO for Remote Functional Assessment of Musculoskeletal Conditions
Knee Osteoarthristis, Hip Osteoarthritis
Not yet recruiting
Clinical Evaluation of TrHCROSS® for Different Joints
Joint Osteoarthritis, Knee Osteoarthristis
RecruitingPhase 4
PRP for Glenohumeral Osteoarthritis
Shoulder Osteoarthritis
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
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FX006 and Normal Saline in people with Osteoarthritis of the Shoulder and Adhesive Capsulitis, run by Pacira Pharmaceuticals, Inc at 27 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 18 inclusion and 35 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 27 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 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 30 Nov 2021). 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?
Area Under the Curve of the Change From Baseline in the Weekly Mean of the Daily Shoulder Pain With Movement (time frame: Baseline to 8 weeks). 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.