OsteoarthritisNCT02195557
Retrospective Follow-up Study of Synvisc® in Patients With Knee Osteoarthritis
An observational study of Osteoarthritis, run by Boehringer Ingelheim.
Trial summary
Retrospective collection of data, aimed at a better knowledge of the use of Synvisc® among the patients with knee osteoarthritis (OA) since at least three years. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Synvisc®
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- Apr 2002to Mar 2003
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: rheumatological practice
Who may be able to join
- Patients with knee osteoarthritis using Synvisc® since at least three years
Who cannot join
- none
About this study
Official title: Synvisc® in Knee Osteoarthritis: Retrospective Follow-up in Treated Patients Since at Least Three Years
Retrospective collection of data, aimed at a better knowledge of the use of Synvisc® among the patients with knee osteoarthritis (OA) since at least three years.
- Conditions
- Osteoarthritis
- Being tested
- Synvisc®
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Synvisc®Drug
| Study group | Role | What they receive |
|---|---|---|
| Synvisc® | Not described Receives: Drug: Synvisc® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reason for prescription
Measured: at least 3 years before start of observation period
Number of other treatments per patient
antalgics, non-steroid anti-inflammatory drugs (NSAIDs), steroid anti-inflammatory drugs (SAIDs), specific symptomatic treatments and surgery
Measured: at least 3 years of observation
Time between two treatments
Measured: at least 3 years of observation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2014 (estimated)
- Study startApr 2002
- Primary completionMar 2003
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 16 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
- NCT02195557
- Sponsor's protocol ID
- 1139.6
- 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
- Synvisc® in Knee Osteoarthritis: Retrospective Follow-up in Treated Patients Since at Least Three Years
- ClinicalTrials.gov ID
- NCT02195557
- Acronym / sponsor ID
- 1139.6
- Conditions
- Osteoarthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Apr 2002
- Primary completion
- Mar 2003 (actual)
- First posted
- 21 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.
Retrospective collection of data, aimed at a better knowledge of the use of Synvisc® among the patients with knee osteoarthritis (OA) since at least three years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Synvisc® | – | Drug: Synvisc® |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- rheumatological practice
Key inclusion criteria (1 listed)
- Patients with knee osteoarthritis using Synvisc® since at least three years
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| Synvisc® | Drug | Synvisc® |
Primary outcome
Reason for prescription
Time frame: at least 3 years before start of observation period
Number of other treatments per patient
Time frame: at least 3 years of observation
antalgics, non-steroid anti-inflammatory drugs (NSAIDs), steroid anti-inflammatory drugs (SAIDs), specific symptomatic treatments and surgery
Time between two treatments
Time frame: at least 3 years of observation
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?
An observational study of 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 1 inclusion and 1 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.
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?
Reason for prescription (time frame: at least 3 years before start of observation period). The study lists 3 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.