OsteoarthritisPhase 4NCT02197026
Effectiveness and Safety of Synvisc® Versus Usual Treatments in Patients With Knee Osteoarthritis
A Phase 4 study testing Hylan G-F 20, Standard treatment and Physiotherapy in people with Osteoarthritis, run by Boehringer Ingelheim.
Trial summary
Comparison of treatment cost of knee osteoarthritis (OA) in patients treated with Synvisc® versus usual treatments as well as evaluation of safety and effectiveness of these treatments. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Hylan G-F 20, Standard treatment and Physiotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 518 participants
- Where
- No sites listed yet
- Study dates
- Oct 1998to Feb 2000
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female outpatient aged at least 18 years
- Patient suffering from predominant femoro-tibial knee osteoarthrosis with or without effusion. The diagnosis must be based on American College of Rheumatology (ACR) criteria. Radiological grade will be assess according to Kellgren-Lawrence scale
- Assessment of pain on active movement (i.e. walking) (by the patient) must be at least 40 mm on a 100 mm VAS
- Patient who received at least two courses of at least ten days within the last three months with non-steroidal antiinflammatory drugs (NSAID) and/or who are treated continuously for the last two month with slow-acting anti-osteoarthritis drugs
- Patient's informed written consent obtained in accordance with French legislation
Who cannot join
- Patient suffering from acute congestive osteoarthritis flare of the target knee (at the time of inclusion) which means that concomitantly to knee effusion at least 2 of the following criteria are present:
- nocturnal disturbances due to knee pain
- morning stiffness over 45 minutes
- increase of knee pain more than 50% within the last week
- articular reddening
- articular heat
Show all 23Show fewer
- Intra-articular administration of hyaluronic acid in the target knee within the previous year
- Intra-articular administration of hyaluronic acid in the target knee within the three previous months
- Any other intra-articular injection in the target knee within the last 6 months
- Any contraindication to intra-articular injections
- Present or past history of infected target knee joint
- Previous prosthesis knee surgery, tibial osteotomy, synovectomy or synoviorthese of the target knee
- Arthroscopy, articular lavage, debridement, menisectomy of the target knee within the previous year
- Planned knee surgery within the nine following month
- Any other musculoskeletal disorders that can interfere with osteoarthritis diagnosis or the evaluation of its severity
- Known hypersensitivity to avian products
- Presence of lymphatic or venous stasis
- Pregnancy or breastfeeding
- Clinical evidence of or known severe cardiac, hepatic, renal, metabolic, haematological disease, mental disturbance
- Participation in another clinical trial during this study or during the previous month
- Previous participation in this trial
- Patient who requires help concerning shopping or house keeping
- Patient unable to comply with the protocol (e.g. patient unable to attend each trial visit or to fill the diary booklet or the quality of life questionnaire)
About this study
Official title: A Multicentre, Open-label and Randomized Clinical Trial to Compare in Patient With Knee Osteoarthritis the Medicoeconomic Benefits as Well as Effectiveness and Safety of Synvisc® Versus Usual Treatments.
Comparison of treatment cost of knee osteoarthritis (OA) in patients treated with Synvisc® versus usual treatments as well as evaluation of safety and effectiveness of these treatments.
- Conditions
- Osteoarthritis
- Being tested
- Hylan G-F 20, Standard treatment, Physiotherapy, Hydrotherapy
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hylan G-F 20Drug
Also called Synvisc®
Standard drug treatment at the discretion of the investigator
PhysiotherapyProcedure or surgery
HydrotherapyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Synvisc group | Experimental | injection of Synvisc® at day 1, day 8 and day 15; in the mean time it will be recommended to decrease or stop all other OA treatments Receives: Drug: Hylan G-F 20 |
| Osteoarthritis standard treatment group | Active comparator | Treatment will be left to the discretion of the investigator who could prescribe any therapies, except viscosupplementation product Receives: Drug: Standard treatment; Procedure: Physiotherapy; Procedure: Hydrotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cost of knee OA treatment including cost of side effect related to OA treatment
Measured: up to 274 days
Area under the curve (AUC) Lequesne index
Index of severity
Measured: Day 1, 29, 91, 182 and 274
Secondary outcomes (9)
Assessment of Western Ontario and McMaster Universities (WOMAC) index by patient
Measured: Day 1, 91, 182 and 274
Patient's assessment of pain on movement and rest on a visual analogue scale (VAS) through WOMAC question 1 and 3
Measured: Day 1, 91, 182 and 274
Disease activity assessment by patient and investigator on a VAS
Measured: Day 1, 29, 91, 182 and 274
Acute congestive OA flares assessed through a questionnaire
Measured: Day 1, 29, 91, 182 and 274
Assessment of state of health of the patients with a quality of life questionnaire (SF 12)
Measured: Day 1, 91, 182, 274
Final global assessment of efficacy by patient and investigator on a four-point verbal rating scale (VRS)
Measured: Day 274
Final global assessment of tolerability by patient and investigator on a four-point VRS
Measured: Day 274
Incidence and intensity of adverse events
Measured: up to day 274
Number of withdrawals due to adverse event
Measured: up to day 274
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2014 (estimated)
- Study startOct 1998
- Primary completionFeb 2000
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.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 518 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02197026
- Sponsor's protocol ID
- 1139.4
- Status last verified
- Jul 2014
- First submitted
- 18 Jul 2014
- Last updated
- 22 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Open-label and Randomized Clinical Trial to Compare in Patient With Knee Osteoarthritis the Medicoeconomic Benefits as Well as Effectiveness and Safety of Synvisc® Versus Usual Treatments.
- ClinicalTrials.gov ID
- NCT02197026
- Acronym / sponsor ID
- 1139.4
- Conditions
- Osteoarthritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 518 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Oct 1998
- Primary completion
- Feb 2000 (actual)
- First posted
- 22 Jul 2014 (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.
Comparison of treatment cost of knee osteoarthritis (OA) in patients treated with Synvisc® versus usual treatments as well as evaluation of safety and effectiveness of these treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Synvisc group | Experimental | Drug: Hylan G-F 20injection of Synvisc® at day 1, day 8 and day 15; in the mean time it will be recommended to decrease or stop all other OA treatments |
| Osteoarthritis standard treatment group | Active comparator | Drug: Standard treatment, Procedure: Physiotherapy, Procedure: HydrotherapyTreatment will be left to the discretion of the investigator who could prescribe any therapies, except viscosupplementation product |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female outpatient aged at least 18 years
- Patient suffering from predominant femoro-tibial knee osteoarthrosis with or without effusion. The diagnosis must be based on American College of Rheumatology (ACR) criteria. Radiological grade will be assess according to Kellgren-Lawrence scale
- Assessment of pain on active movement (i.e. walking) (by the patient) must be at least 40 mm on a 100 mm VAS
- Patient who received at least two courses of at least ten days within the last three months with non-steroidal antiinflammatory drugs (NSAID) and/or who are treated continuously for the last two month with slow-acting anti-osteoarthritis drugs
- Patient's informed written consent obtained in accordance with French legislation
Key exclusion criteria (23 listed)
- Patient suffering from acute congestive osteoarthritis flare of the target knee (at the time of inclusion) which means that concomitantly to knee effusion at least 2 of the following criteria are present:
- Intra-articular administration of hyaluronic acid in the target knee within the previous year
- Intra-articular administration of hyaluronic acid in the target knee within the three previous months
- Any other intra-articular injection in the target knee within the last 6 months
- Any contraindication to intra-articular injections
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 G-F 20Also: Synvisc® | Drug | Synvisc group |
| Standard treatmentStandard drug treatment at the discretion of the investigator | Drug | Osteoarthritis standard treatment group |
| Physiotherapy | Procedure or surgery | Osteoarthritis standard treatment group |
| Hydrotherapy | Procedure or surgery | Osteoarthritis standard treatment group |
Primary outcome
Cost of knee OA treatment including cost of side effect related to OA treatment
Time frame: up to 274 days
Area under the curve (AUC) Lequesne index
Time frame: Day 1, 29, 91, 182 and 274
Index of severity
9 secondary outcomes
Assessment of Western Ontario and McMaster Universities (WOMAC) index by patient
Time frame: Day 1, 91, 182 and 274
Patient's assessment of pain on movement and rest on a visual analogue scale (VAS) through WOMAC question 1 and 3
Time frame: Day 1, 91, 182 and 274
Disease activity assessment by patient and investigator on a VAS
Time frame: Day 1, 29, 91, 182 and 274
Acute congestive OA flares assessed through a questionnaire
Time frame: Day 1, 29, 91, 182 and 274
Assessment of state of health of the patients with a quality of life questionnaire (SF 12)
Time frame: Day 1, 91, 182, 274
Final global assessment of efficacy by patient and investigator on a four-point verbal rating scale (VRS)
Time frame: Day 274
Final global assessment of tolerability by patient and investigator on a four-point VRS
Time frame: Day 274
Incidence and intensity of adverse events
Time frame: up to day 274
Number of withdrawals due to adverse event
Time frame: up to day 274
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 22 Jul 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hylan G-F 20, Standard treatment and Physiotherapy in people with Osteoarthritis, run by Boehringer Ingelheim.
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 5 inclusion and 23 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 22 Jul 2014. 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?
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?
Cost of knee OA treatment including cost of side effect related to OA treatment (time frame: up to 274 days). 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 22 Jul 2014.