OsteoarthritisNCT02182726
Postmarketing Surveillance Study With MOBEC®
An observational study of Osteoarthritis, run by Boehringer Ingelheim.
Trial summary
The aim of the study is to investigate the indication for MOBEC in a dose of 15 mg per day the treatments patients were receiving before switching to 15 mg MOBEC how treatment with 15 mg is assessed compared with previous treatment how effective and safe treatment with 15 mg MOBEC is considered Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- MOBEC
- How many people
- 4,760 participants
- Where
- No sites listed yet
- Study dates
- May 2001to Dec 2001
- 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: primarily internal and general medical practices
Who may be able to join
- An indication for a treatment with 15 mg MOBEC of at least four weeks
- the symptomatic short-term treatment of osteoarthritis
- the symptomatic long-term treatment of rheumatoid arthritis (chronic polyarthritis); restriction: the recommended dose for long-term treatment of elderly patients is 7.5 mg)
- the symptomatic treatment of ankylosing spondylitis
Who cannot join
- Treatment with MOBEC prior to the start of the study
- Patients with any of the general or specific contraindications of MOBEC
About this study
Official title: COX-2 Postmarketing Surveillance Study With MOBEC® 15 mg Tablets
The aim of the study is to investigate
- the indication for MOBEC in a dose of 15 mg per day
- the treatments patients were receiving before switching to 15 mg MOBEC
- how treatment with 15 mg is assessed compared with previous treatment
- how effective and safe treatment with 15 mg MOBEC is considered
- Conditions
- Osteoarthritis
- Being tested
- MOBEC
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MOBECDrug
| Study group | Role | What they receive |
|---|---|---|
| MOBEC | Not described Receives: Drug: MOBEC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nature and incidence of adverse drug reactions (ADR)
Measured: up to week 8
Assessment of efficacy by physician on a 5-point scale
Measured: up to week 8
Assessment of tolerability by physician on a 5-point scale
Measured: up to week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2014 (estimated)
- Study startMay 2001
- Primary completionDec 2001
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
- 4,760 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
- NCT02182726
- Sponsor's protocol ID
- 107.245
- Status last verified
- Jul 2014
- First submitted
- 3 Jul 2014
- Last updated
- 9 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COX-2 Postmarketing Surveillance Study With MOBEC® 15 mg Tablets
- ClinicalTrials.gov ID
- NCT02182726
- Acronym / sponsor ID
- 107.245
- Conditions
- Osteoarthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,760 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- May 2001
- Primary completion
- Dec 2001 (actual)
- First posted
- 8 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.
The aim of the study is to investigate
- the indication for MOBEC in a dose of 15 mg per day
- the treatments patients were receiving before switching to 15 mg MOBEC
- how treatment with 15 mg is assessed compared with previous treatment
- how effective and safe treatment with 15 mg MOBEC is considered
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MOBEC | – | Drug: MOBEC |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- primarily internal and general medical practices
Key inclusion criteria (4 listed)
- An indication for a treatment with 15 mg MOBEC of at least four weeks
Key exclusion criteria (2 listed)
- Treatment with MOBEC prior to the start of the study
- Patients with any of the general or specific contraindications of MOBEC
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 |
|---|---|---|
| MOBEC | Drug | MOBEC |
Primary outcome
Nature and incidence of adverse drug reactions (ADR)
Time frame: up to week 8
Assessment of efficacy by physician on a 5-point scale
Time frame: up to week 8
Assessment of tolerability by physician on a 5-point scale
Time frame: up to week 8
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 9 Jul 2014.
- Related InfoLink provided by the sponsor.
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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 4 inclusion and 2 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 9 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?
Nature and incidence of adverse drug reactions (ADR) (time frame: up to week 8). 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 9 Jul 2014.