OsteoarthritisNCT02184039
Efficacy and Safety of Meloxicam (Mobicox®) in Mexican Population With Rheumatic Diseases
An observational study of Osteoarthritis, run by Boehringer Ingelheim.
Trial summary
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
- Osteoarthritis
- How many people
- 12,687 participants
- Where
- No sites listed yet
- Study dates
- May 2003to Jul 2004
- 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
- none
Who cannot join
- Hypersensitivity to meloxicam or to other NSAIDS
- History of asthma, angioedema or urticaria secondary to NSAIDS
- Pregnancy or lactation
- Recent or current history of peptic ulcer disease, severe renal failure, severe hepatic failure
- Age below of 12 years.
About this study
Official title: Clinical Therapeutic Evaluation Program in Patients With Rheumatic Diseases
Study to evaluate the efficacy and safety of meloxicam (Mobicox®) in Mexican population with rheumatic diseases.
- Conditions
- Osteoarthritis
- Medical subject headings
- Osteoarthritis
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in intensity of the symptoms measured with a four-point scale
Measured: Baseline, 30 and 90 days
Secondary outcomes (2)
Degree of satisfaction evaluated with a six point numerical rating scale
Measured: up to 90 days
Number of patients with adverse events
Measured: up to 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 startMay 2003
- Primary completionJul 2004
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
- 12,687 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
- NCT02184039
- Sponsor's protocol ID
- 107.264
- 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 Therapeutic Evaluation Program in Patients With Rheumatic Diseases
- ClinicalTrials.gov ID
- NCT02184039
- Acronym / sponsor ID
- 107.264
- Conditions
- Osteoarthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12,687 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- May 2003
- Primary completion
- Jul 2004 (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 evaluate the efficacy and safety of meloxicam (Mobicox®) in Mexican population with rheumatic diseases.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
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)
- none
Key exclusion criteria (5 listed)
- Hypersensitivity to meloxicam or to other NSAIDS
- History of asthma, angioedema or urticaria secondary to NSAIDS
- Pregnancy or lactation
- Recent or current history of peptic ulcer disease, severe renal failure, severe hepatic failure
- Age below of 12 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in intensity of the symptoms measured with a four-point scale
Time frame: Baseline, 30 and 90 days
2 secondary outcomes
Degree of satisfaction evaluated with a six point numerical rating scale
Time frame: up to 90 days
Number of patients with adverse events
Time frame: up to 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.
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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 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?
Change in intensity of the symptoms measured with a four-point scale (time frame: Baseline, 30 and 90 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.