Arthritis, RheumatoidNCT02184052
Safety and Efficacy of Mobic® Ampoules in the Initiation of Treatment of Painful Exacerbations of Osteoarthritis, Rheumatoid Arthritis and Other Similar Painful Inflammatory Conditions
An observational study of Arthritis, Rheumatoid, run by Boehringer Ingelheim.
Trial summary
Study to determine the safety and efficacy of Mobic® ampoules in the initiation of treatment of painful exacerbations of osteoarthritis, rheumatoid arthritis and other similar painful inflammatory conditions. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Arthritis, Rheumatoid
- What is being tested?
- Meloxicam
- How many people
- 121 participants
- Where
- No sites listed yet
- Study dates
- Jul 2003to Mar 2005
- 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
Who may be able to join
- Painful acute exacerbations of inflammatory rheumatism (rheumatoid arthritis and ankylosing spondylitis), painful acute exacerbations of osteoarthritis and other similar conditions requiring acute treatment with an anti-inflammatory drug
Who cannot join
- none
About this study
Official title: Meloxicam (MOBIC®) Ampoule Post Marketing Surveillance Study
Study to determine the safety and efficacy of Mobic® ampoules in the initiation of treatment of painful exacerbations of osteoarthritis, rheumatoid arthritis and other similar painful inflammatory conditions.
- Conditions
- Arthritis, Rheumatoid
- Being tested
- Meloxicam
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MeloxicamDrug
7.5 mg or 15 mg
| Study group | Role | What they receive |
|---|---|---|
| Meloxicam | Not described Receives: Drug: Meloxicam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall assessment of degree of pain on a 3-point scale
Measured: up to 3 days
Secondary outcomes (1)
Number of patients with adverse events
Measured: up to 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2014 (estimated)
- Study startJul 2003
- Primary completionMar 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis, RheumatoidStudies 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
- 121 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
- NCT02184052
- Sponsor's protocol ID
- 107.267
- 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
- Meloxicam (MOBIC®) Ampoule Post Marketing Surveillance Study
- ClinicalTrials.gov ID
- NCT02184052
- Acronym / sponsor ID
- 107.267
- Conditions
- Arthritis, Rheumatoid
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jul 2003
- Primary completion
- Mar 2005 (actual)
- First posted
- 9 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.
Study to determine the safety and efficacy of Mobic® ampoules in the initiation of treatment of painful exacerbations of osteoarthritis, rheumatoid arthritis and other similar painful inflammatory conditions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Meloxicam | – | Drug: Meloxicam |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Painful acute exacerbations of inflammatory rheumatism (rheumatoid arthritis and ankylosing spondylitis), painful acute exacerbations of osteoarthritis and other similar conditions requiring acute treatment with an anti-inflammatory drug
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 |
|---|---|---|
| Meloxicam7.5 mg or 15 mg | Drug | Meloxicam |
Primary outcome
Overall assessment of degree of pain on a 3-point scale
Time frame: up to 3 days
1 secondary outcome
Number of patients with adverse events
Time frame: up to 3 days
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 Arthritis, Rheumatoid, 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 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?
Overall assessment of degree of pain on a 3-point scale (time frame: up to 3 days). 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.