Painful Shoulder OsteoarthritisPhase 4NCT00253799
A Safety Study of Hylan GF-20 to Treat Shoulder Osteoarthritis
A Phase 4 study testing Hylan GF-20 in people with Painful Shoulder Osteoarthritis, run by Northwestern Ophthalmic Institute S.C..
Trial summary
The objective is to assess the safety and efficacy (over the course of 26 weeks) of 2 intra-articular (IA) Hylan GF-20 (Synvisc) injections in addition to customary care in patients with painful glenohumeral osteoarthritis. Read more about this study
- Who is it for?
- Ages 35 years and olderHealthy volunteers can take part
- Conditions the study is for
- Painful Shoulder Osteoarthritis
- What is being tested?
- Hylan GF-20
- Type of treatment
- Medical device
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- Dec 2005to not given
- Phase
- Phase 4
- 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 35 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- • Be will and able to provide written informed consent prior to any study-related procedures being performed and able to understand and comply with the requirements of this study.
- Agree to receive fluoroscopically guided injections.
- Be men or women aged 35 years or older.
- If female and of childbearing age, must have a negative pregnancy test and have taken oral contraceptives for at least one month prior to treatment and continue for the duration of the study (up to and including the final study visit) or agree to use 2 forms of contraception; otherwise females must be surgically sterile or postmenopausal for at least one year.
- Have painful, non-inflammatory unilateral osteoarthritis of the shoulder. OA in the contralateral shoulder is permissible provided that the OA symptoms are greater in the study joint. The presence of soft tissue pathology (e.g., rotator cuff tear) is permitted, and will be evaluated by an MRI (taken within 6 months of study entry).
- Report an initial visual analogue pain score (VAS) of ≥ 30 and ≤ 80.
- Have radiographic confirmation of osteoarthritis of the shoulder prior to baseline (modified Kellgren and Lawrence Numerical Grading System Grades II - IV) on radiographs performed within 12 weeks of screening
- Have pain from shoulder OA requiring frequent (> 3 days/week) use of analgesics or NSAIDs for at least 8 weeks prior to screening.
Who cannot join
- • Pregnant, lactating, or unwilling to use adequate contraception.
- Prior viscosupplementation in target shoulder joint within 1 year of study entry.
- Known sensitivity to avian protein or any components of hyaluronan based infection devices, steroids, lidocaine.
- Known Sensitivity to contrast agent.
- Used systemic steroids or have had an intra-articular steroid injection in the target shoulder within the last 3 months.
- Rapidly progressive disease.
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- Acute disease or trauma leading to osteoarthritis of the joint within 2 years of study entry.
- Presence of a primary inflammatory arthropathy (e.g., rheumatoid, psoriatic, or gouty arthritis).
- Active skin or soft tissue infection in the area of the injection site.
- Cervical spin disorders (e.g., radiculopathy) that have been symptomatic and required active treatment within the past 3 months.
- Any active musculoskeletal condition that would impede measurement of the efficacy of the target shoulder joint (such as fibromyalgia).
- Any major surgery, arthroplasty or arthroscopy in the target shoulder within 26 weeks of screening or planned surgery within the duration of the study.
- Septic arthritis in any joints within 3 months prior to screening; any history of septic arthritis in the target shoulder.
- Any significant chronic skin disorders that could interfere with the evaluation of the injection site.
- Uncontrolled diabetes mellitus, diabetic neuropathy or infectious complications.
- Active malignancy receiving treatment.
- Taking warfarin or parental anticoagulant therapy.
- Active asthma that may require periodic treatment with steroids during the study period.
- Use of investigational drug, device, or biologic within 12 weeks of screening
- Patients with ongoing litigation or workman's compensation claim.
About this study
Official title: Prospective, Single Arm, Pilot Study Evaluating the Safety and Efficacy of Hyaluronan (Hylan GF-20) in Patients With Painful Shoulder Osteoarthritis
The objective is to assess the safety and efficacy (over the course of 26 weeks) of 2 intra-articular (IA) Hylan GF-20 (Synvisc) injections in addition to customary care in patients with painful glenohumeral osteoarthritis.
- Conditions
- Painful Shoulder Osteoarthritis
- Being tested
- Hylan GF-20
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hylan GF-20Device
What is being measured
The primary outcome is the main question the study is designed to answer.
-Change from baseline to week 26 evaluation of patient's assessment of pain (VAS rest, motion, night)
-Change from Baseline to follow-up in overall pain and function (WOMAC shoulder rating questionnaire)
Secondary outcomes (2)
-Absolute change in passive range of motion, in flexion, abduction, internal and external rotation
-Requirements for rescue medication use for pain of the shoulder at each scheduled visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2005 (estimated)
- Study startDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Painful Shoulder OsteoarthritisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern Ophthalmic Institute S.C.
- Sponsor type
- University, hospital or other
- Investigators
- Victoria A Brander, MD, Principal investigator, Northwestern Ophthalmic Institute S.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00253799
- Sponsor's protocol ID
- 0133-003
- Status last verified
- Jun 2007
- First submitted
- 10 Nov 2005
- Last updated
- 25 Jun 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Single Arm, Pilot Study Evaluating the Safety and Efficacy of Hyaluronan (Hylan GF-20) in Patients With Painful Shoulder Osteoarthritis
- ClinicalTrials.gov ID
- NCT00253799
- Acronym / sponsor ID
- 0133-003
- Conditions
- Painful Shoulder Osteoarthritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Northwestern Ophthalmic Institute S.C.University, hospital or other
- Study start
- Dec 2005
- First posted
- 15 Nov 2005 (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 objective is to assess the safety and efficacy (over the course of 26 weeks) of 2 intra-articular (IA) Hylan GF-20 (Synvisc) injections in addition to customary care in patients with painful glenohumeral osteoarthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- • Be will and able to provide written informed consent prior to any study-related procedures being performed and able to understand and comply with the requirements of this study.
Key exclusion criteria (20 listed)
- • Pregnant, lactating, or unwilling to use adequate contraception.
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 |
|---|---|---|
| Hylan GF-20 | Device | – |
Primary outcome
-Change from baseline to week 26 evaluation of patient's assessment of pain (VAS rest, motion, night)
-Change from Baseline to follow-up in overall pain and function (WOMAC shoulder rating questionnaire)
2 secondary outcomes
-Absolute change in passive range of motion, in flexion, abduction, internal and external rotation
-Requirements for rescue medication use for pain of the shoulder at each scheduled visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2007.
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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.
Victoria A Brander, MD principal investigator
Northwestern Ophthalmic Institute S.C.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hylan GF-20 in people with Painful Shoulder Osteoarthritis, run by Northwestern Ophthalmic Institute S.C..
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 20 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: status not confirmed, as of the sponsor's last update on 25 Jun 2007. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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 26 evaluation of patient's assessment of pain (VAS rest, motion, night). The study lists 2 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 25 Jun 2007.