Arthritis, RheumatoidNCT02182739
Observational Study of Meloxicam in Any Labeled Indication
An observational study of Arthritis, Rheumatoid, run by Boehringer Ingelheim.
Trial summary
Evaluation on the amelioration of symptom intensity of the indication and to evaluate drug tolerability. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Arthritis, Rheumatoid
- What is being tested?
- Meloxicam
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 13,039 participants
- Where
- No sites listed yet
- Study dates
- Jan 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: primary care
Who may be able to join
- Patients according to the physicians medical criteria on the labeled indications for Meloxicam
Who cannot join
- none
About this study
Official title: Programa de Experiencia Therapéutica Personalizada (Personalized Therapeutic Experience Program)
Evaluation on the amelioration of symptom intensity of the indication and to evaluate drug tolerability.
- 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
tablets or injectable solution
| 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.
Change in assessment of intensity of pain on a 4-point verbal rating scale
Measured: up to 1 year
Assessment of tolerability on a 4-point scale
Measured: up to 1 year
Secondary outcomes (1)
Number of patients with adverse events
Measured: up to 1 year
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 startJan 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 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
- 13,039 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
- NCT02182739
- Sponsor's protocol ID
- 107.249
- Status last verified
- Jul 2014
- First submitted
- 3 Jul 2014
- Last updated
- 29 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Programa de Experiencia Therapéutica Personalizada (Personalized Therapeutic Experience Program)
- ClinicalTrials.gov ID
- NCT02182739
- Acronym / sponsor ID
- 107.249
- Conditions
- Arthritis, Rheumatoid
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13,039 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jan 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.
Evaluation on the amelioration of symptom intensity of the indication and to evaluate drug tolerability.
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
- Study population
- primary care
Key inclusion criteria (1 listed)
- Patients according to the physicians medical criteria on the labeled indications for Meloxicam
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 |
|---|---|---|
| Meloxicamtablets or injectable solution | Drug | Meloxicam |
Primary outcome
Change in assessment of intensity of pain on a 4-point verbal rating scale
Time frame: up to 1 year
Assessment of tolerability on a 4-point scale
Time frame: up to 1 year
1 secondary outcome
Number of patients with adverse events
Time frame: up to 1 year
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 29 Oct 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 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 29 Oct 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 assessment of intensity of pain on a 4-point verbal rating scale (time frame: up to 1 year). The study lists 2 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 29 Oct 2014.