Arthritis, RheumatoidNCT02184065
Observational Study of Meloxicam in Mexican Patients With Rheumatic Diseases
An observational study of Arthritis, Rheumatoid, run by Boehringer Ingelheim.
Trial summary
Observational study to evaluate the efficacy and safety of meloxicam (Mobicox®) in Mexican population with rheumatic diseases Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Arthritis, Rheumatoid
- What is being tested?
- Meloxicam
- How many people
- 22,639 participants
- Where
- No sites listed yet
- Study dates
- Jan 2004to Apr 2007
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age of 12 or older and rheumatologic disease
Who cannot join
- Hypersensitivity to meloxicam
- Hypersensitivity to other Non-steroidal anti-inflammatory drugs (NSAIDS)
- History of asthma, angioedema or urticaria secondary to NSAIDS
- Pregnancy or lactation
- Recent or current history of peptic ulcer disease, severe renal failure and severe hepatic failure
About this study
Official title: Clinical and Therapeutic Evaluation of Meloxicam in Mexican Patients With Rheumatic Diseases
Observational study to evaluate the efficacy and safety of meloxicam (Mobicox®) in Mexican population with rheumatic diseases
- 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
| 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.
Intensity of symptoms at rest evaluated with a 4-point scale
Measured: 30 and 90 days
Intensity of symptoms during movement evaluated with a 4-point scale
Measured: 30 and 90 days
Medical global evaluation on a 4-point scale
Measured: 30 and 90 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 startJan 2004
- Primary completionApr 2007
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
- 22,639 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
- NCT02184065
- Sponsor's protocol ID
- 107.272
- 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
- Clinical and Therapeutic Evaluation of Meloxicam in Mexican Patients With Rheumatic Diseases
- ClinicalTrials.gov ID
- NCT02184065
- Acronym / sponsor ID
- 107.272
- Conditions
- Arthritis, Rheumatoid
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22,639 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jan 2004
- Primary completion
- Apr 2007 (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.
Observational study to evaluate the efficacy and safety of meloxicam (Mobicox®) in Mexican population with rheumatic diseases
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Meloxicam | – | Drug: Meloxicam |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Age of 12 or older and rheumatologic disease
Key exclusion criteria (5 listed)
- Hypersensitivity to meloxicam
- Hypersensitivity to other Non-steroidal anti-inflammatory drugs (NSAIDS)
- History of asthma, angioedema or urticaria secondary to NSAIDS
- Pregnancy or lactation
- Recent or current history of peptic ulcer disease, severe renal failure and severe hepatic failure
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 |
|---|---|---|
| Meloxicam | Drug | Meloxicam |
Primary outcome
Intensity of symptoms at rest evaluated with a 4-point scale
Time frame: 30 and 90 days
Intensity of symptoms during movement evaluated with a 4-point scale
Time frame: 30 and 90 days
Medical global evaluation on a 4-point scale
Time frame: 30 and 90 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 5 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?
Intensity of symptoms at rest evaluated with a 4-point scale (time frame: 30 and 90 days). 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.