OsteoarthritisPhase 2/3NCT00423371
Double-Blind,Randomized,Placebo-Controlled Efficacy & Safety Study of EUFLEXXA™ for Treatment of OA of the First CMC
A Phase 2/3 study testing sodium hyaluronate in people with Osteoarthritis, run by Ferring Pharmaceuticals at 1 site in United States.
Trial summary
This multicenter, double-blind, randomized, parallel-group, active-controlled trial will be performed in approximately 80 subjects with chronic idiopathic osteoarthritis (OA) of the first carpo-metacarpal joint (CMC). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- sodium hyaluronate
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 79 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2006to Sep 2007
- Phase
- Phase 2/3
- 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
- Men or women ≥40 years of age
- Pain due to primary OA of the first CMC joint present for at least half the days of the previous month AND a mean combined pain score ≥ 30 mm out of 100 mm of the 5 pain questions on the AUSCAN Index Pain Subscale (See Appendix 1)
- A series of X-rays confirming OA of the first CMC joint of the target thumb obtained at screening with a stage of 2, 3, or 4 according to Grading Scale in Appendix 3.
- Ability and willingness to use only acetaminophen as the analgesic (rescue) study medication
- The acetaminophen dose must not exceed 4 grams/day (4000 mg)
- If subject has known chronic liver disease, the maximum dose of acetaminophen must not exceed 2 grams/day (2000 mg)
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- The subject must be willing and able to discontinue acetaminophen at least 24 hours prior to all study-specific visits
- The study specific acetaminophen provided will only be used for thumb/joint pain.
- Willingness and ability to complete efficacy and safety questionnaires and ability to read and understand study instructions
- Signed study-specific Subject Informed Consent Form
Who cannot join
- Any major injury to the target thumb within the 6 months prior to the Screening Visit
- Anyone having Carpal Tunnel Syndrome (CTS), DeQuervain's tenosynovitis, trigger finger, or a ganglion cyst of the target hand ONLY IF there is evidence of extreme atrophy AND two-point average discrimination is greater than 10-mm, OR if the pain from these conditions renders the subject unable to objectively assess OA pain in the target hand
- Any surgery to the target joint within the 12 months prior to the Screening Visit
- Regular use of assistive devices such as a cane or crutch or a CTS brace
- Concomitant rheumatic disease (rheumatoid arthritis, lupus arthropathy, psoriatic arthritis)
- History of chondrocalcinosis in the target joint
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- Gout exacerbation in any joint in the past 6 months
- X-ray findings of acute fractures, severe loss of bone density, and/or severe bone or joint deformity in the target joint
- Significant target joint infection or skin disorder/infection within the 3 months prior to study enrollment
- Known hypersensitivity to acetaminophen, EUFLEXXA™, or Phosphate Buffered Saline solution
- Women of childbearing potential who are pregnant, nursing, or planning to become pregnant, and those who do not agree to remain on an acceptable method of birth control throughout the entire study period
- Recurrent medical history of severe allergic or immune-mediated reactions or other immune disorders
- Current treatment or treatment within the previous 2 years prior to the Screening Visit for any malignancy unless specific written permission is provided by the Sponsor (excluding basal cell or squamous cell carcinoma of the skin)
- Active liver disease based on liver profile of AST, ALT, and conjugated bilirubin >2 times the upper limit of normal
- Renal insufficiency based on serum creatinine >2.0 mg/dL
- Any clinically significant laboratory value based on clinical history that the Investigator feels may affect the study evaluation
- Any intercurrent chronic disease or condition that may interfere with the completion of the 6-month follow-up of the study, such as liver disease, severe coronary disease, drug abuse, disordered mental state, or other clinically significant condition
- Current alcoholism, and/or any known current addiction to pain medications
- Any clinically significant finding that would place the subject at health risk, impact the study, or affect the completion of the study
- Any psychiatric illness that would prevent comprehension of the details and nature of the study
- Participation in any experimental device study within 6 months prior to the Screening Visit, or an experimental drug study within 1 month prior to the Screening Visit
Trial locations and contacts
1 site in 1 country.
United States1 site
All Florida Orthopedic Association
St. Petersburg, Florida, 33703
About this study
Official title: A Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of EUFLEXXA™ for Treatment of Osteoarthritis (OA) of the First Carpometacarpal (CMC) Joint
This multicenter, double-blind, randomized, parallel-group, active-controlled trial will be performed in approximately 80 subjects with chronic idiopathic osteoarthritis (OA) of the first carpo-metacarpal joint (CMC).
- Conditions
- Osteoarthritis
- Being tested
- sodium hyaluronate, placebo
- Keywords
- first Carpometacarpal (CMC) Joint
- Medical subject headings
- Osteoarthritis, Capillary Malformations, Congenital, 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sodium hyaluronateDevice
Also called EUFLEXXA™
EUFLEXXA™ is supplied in a single-dose syringe containing 20 mg/2 ml of 1% sodium hyaluronate. Each subject will receive three single dose injections into the target first CMC joint on study weeks 0, 2 and 4.
placeboDevice
Placebo is supplied in a disposable prefilled glass syringe. Each single-dose syringe will contain 2 mL of phosphate buffered saline. Each subject will receive three single dose injections into the target first CMC joint on study weeks 0, 2 and 4.
| Study group | Role | What they receive |
|---|---|---|
| EUFLEXXA™ | Experimental | Not described Receives: Device: sodium hyaluronate |
| Placebo | Placebo comparator | Not described Receives: Device: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in pain scores as reported by the patient on the AUSCAN Index pain subscale
Measured: weeks 0 and 26
Secondary outcomes (3)
Mean change in stiffness and function scores as reported by the patient on the AUSCAN Index stillness and function subscale
Measured: weeks 0 and 26
Change in Patient Global Assessment of Symptoms measured by 100mm visual analog scale (VAS)
Measured: Weeks 0 and 26
Number of tablets of rescue medication used between visits
Measured: Weeks 0 and 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2007 (estimated)
- Study startDec 2006
- Primary completionSep 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ferring Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Clinical Development Support, Study director, Ferring Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00423371
- Sponsor's protocol ID
- 2006-02
- Status last verified
- May 2011
- First submitted
- 17 Jan 2007
- Last updated
- 19 May 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of EUFLEXXA™ for Treatment of Osteoarthritis (OA) of the First Carpometacarpal (CMC) Joint
- ClinicalTrials.gov ID
- NCT00423371
- Acronym / sponsor ID
- 2006-02
- Conditions
- Osteoarthritis
- Keywords
- first Carpometacarpal (CMC) Joint
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 18 Jan 2007 (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.
This multicenter, double-blind, randomized, parallel-group, active-controlled trial will be performed in approximately 80 subjects with chronic idiopathic osteoarthritis (OA) of the first carpo-metacarpal joint (CMC).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EUFLEXXA™ | Experimental | Device: sodium hyaluronate |
| Placebo | Placebo comparator | Device: placebo |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Men or women ≥40 years of age
- Pain due to primary OA of the first CMC joint present for at least half the days of the previous month AND a mean combined pain score ≥ 30 mm out of 100 mm of the 5 pain questions on the AUSCAN Index Pain Subscale (See Appendix 1)
- A series of X-rays confirming OA of the first CMC joint of the target thumb obtained at screening with a stage of 2, 3, or 4 according to Grading Scale in Appendix 3.
- Ability and willingness to use only acetaminophen as the analgesic (rescue) study medication
- Willingness and ability to complete efficacy and safety questionnaires and ability to read and understand study instructions
Key exclusion criteria (21 listed)
- Any major injury to the target thumb within the 6 months prior to the Screening Visit
- Anyone having Carpal Tunnel Syndrome (CTS), DeQuervain's tenosynovitis, trigger finger, or a ganglion cyst of the target hand ONLY IF there is evidence of extreme atrophy AND two-point average discrimination is greater than 10-mm, OR if the pain from these conditions renders the subject unable to objectively assess OA pain in the target hand
- Any surgery to the target joint within the 12 months prior to the Screening Visit
- Regular use of assistive devices such as a cane or crutch or a CTS brace
- Concomitant rheumatic disease (rheumatoid arthritis, lupus arthropathy, psoriatic arthritis)
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 |
|---|---|---|
| sodium hyaluronateAlso: EUFLEXXA™EUFLEXXA™ is supplied in a single-dose syringe containing 20 mg/2 ml of 1% sodium hyaluronate. Each subject will receive three single dose injections into the target first CMC joint on study weeks 0, 2 and 4. | Device | EUFLEXXA™ |
| placeboPlacebo is supplied in a disposable prefilled glass syringe. Each single-dose syringe will contain 2 mL of phosphate buffered saline. Each subject will receive three single dose injections into the target first CMC joint on study weeks 0, 2 and 4. | Device | Placebo |
Primary outcome
Mean change in pain scores as reported by the patient on the AUSCAN Index pain subscale
Time frame: weeks 0 and 26
3 secondary outcomes
Mean change in stiffness and function scores as reported by the patient on the AUSCAN Index stillness and function subscale
Time frame: weeks 0 and 26
Change in Patient Global Assessment of Symptoms measured by 100mm visual analog scale (VAS)
Time frame: Weeks 0 and 26
Number of tablets of rescue medication used between visits
Time frame: Weeks 0 and 26
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 19 May 2011.
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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.
Clinical Development Support study director
Ferring Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing sodium hyaluronate in people with Osteoarthritis, run by Ferring Pharmaceuticals at 1 site 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 10 inclusion and 21 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 19 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 combined 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.
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?
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?
Mean change in pain scores as reported by the patient on the AUSCAN Index pain subscale (time frame: weeks 0 and 26). 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 19 May 2011.