Arthritis, RheumatoidNCT02180516
Safety and Efficacy of Meloxicam Compared to Other Nonsteroidal Antiinflammatory Drugs (NSAIDs) in an Observational Cohort Study of Patients With Rheumatoid Arthritis, Osteoarthritis, Lumbago, Scapulohumeral Periarthritis, Neck, Shoulder and Arm Syndrome
An observational study of Arthritis, Rheumatoid, run by Boehringer Ingelheim.
Trial summary
Study to assess the safety profile of meloxicam by comparing incidence of gastrointestinal adverse events of meloxicam with that of NSAID in the routine daily therapeutic situation. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Arthritis, Rheumatoid
- What is being tested?
- Meloxicam and Other Non Steroidal Anti-Inflammatory Drugs (NSAIDs) except etodolac
- How many people
- 9,984 participants
- Where
- No sites listed yet
- Study dates
- Oct 2001to Sep 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients from hospitals or general practioners (Internal Medicine, Orthopedics)
Who may be able to join
- Patients with Indications according to the package insert of the prescribed NSAID
Who cannot join
- There is no exclusion criterion, because this Post Marketing Study is an observational study
About this study
Official title: Safety and Efficacy of Meloxicam (MOBIC) Compared to Other NSAIDs in Approved Therapeutic Dosages and Routes of Administration in an Observational Cohort Study of Patients With Rheumatoid Arthritis, Osteoarthritis, Lumbago, Scapulohumeral Periarthritis, Neck, Shoulder and Arm Syndrome
Study to assess the safety profile of meloxicam by comparing incidence of gastrointestinal adverse events of meloxicam with that of NSAID in the routine daily therapeutic situation.
- Conditions
- Arthritis, Rheumatoid
- Being tested
- Meloxicam, Other Non Steroidal Anti-Inflammatory Drugs (NSAIDs) except etodolac
- 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
Other Non Steroidal Anti-Inflammatory Drugs (NSAIDs) except etodolacDrug
| Study group | Role | What they receive |
|---|---|---|
| Meloxicam | Not described Receives: Drug: Meloxicam | |
| Other NSAIDs | Not described Receives: Drug: Other Non Steroidal Anti-Inflammatory Drugs (NSAIDs) except etodolac |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence for adverse event of gastrointestinal disorder
Measured: up to 6 months
Secondary outcomes (5)
Incidence for adverse drug reaction of gastrointestinal disorder
Measured: up to 6 months
Incidence of adverse events
Measured: up to 6 months
Incidence of adverse drug reactions
Measured: up to 6 months
Incidence of serious adverse events
Measured: up to 6 months
Incidence for adverse events Perforation, Ulcer and Bleeding (PUB) in the upper gastrointestinal tract
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2014 (estimated)
- Study startOct 2001
- Primary completionSep 2004
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
- 9,984 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
- NCT02180516
- Sponsor's protocol ID
- 107.246
- Status last verified
- Jul 2014
- First submitted
- 1 Jul 2014
- Last updated
- 8 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Meloxicam (MOBIC) Compared to Other NSAIDs in Approved Therapeutic Dosages and Routes of Administration in an Observational Cohort Study of Patients With Rheumatoid Arthritis, Osteoarthritis, Lumbago, Scapulohumeral Periarthritis, Neck, Shoulder and Arm Syndrome
- ClinicalTrials.gov ID
- NCT02180516
- Acronym / sponsor ID
- 107.246
- Conditions
- Arthritis, Rheumatoid
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9,984 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Oct 2001
- Primary completion
- Sep 2004 (actual)
- First posted
- 2 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 assess the safety profile of meloxicam by comparing incidence of gastrointestinal adverse events of meloxicam with that of NSAID in the routine daily therapeutic situation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Meloxicam | – | Drug: Meloxicam |
| Other NSAIDs | – | Drug: Other Non Steroidal Anti-Inflammatory Drugs (NSAIDs) except etodolac |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients from hospitals or general practioners (Internal Medicine, Orthopedics)
Key inclusion criteria (1 listed)
- Patients with Indications according to the package insert of the prescribed NSAID
Key exclusion criteria (1 listed)
- There is no exclusion criterion, because this Post Marketing Study is an observational study
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 |
| Other Non Steroidal Anti-Inflammatory Drugs (NSAIDs) except etodolac | Drug | Other NSAIDs |
Primary outcome
Incidence for adverse event of gastrointestinal disorder
Time frame: up to 6 months
5 secondary outcomes
Incidence for adverse drug reaction of gastrointestinal disorder
Time frame: up to 6 months
Incidence of adverse events
Time frame: up to 6 months
Incidence of adverse drug reactions
Time frame: up to 6 months
Incidence of serious adverse events
Time frame: up to 6 months
Incidence for adverse events Perforation, Ulcer and Bleeding (PUB) in the upper gastrointestinal tract
Time frame: up to 6 months
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 8 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 8 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?
Incidence for adverse event of gastrointestinal disorder (time frame: up to 6 months). 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 8 Jul 2014.