OsteoarthritisPhase 4NCT02183116
A Study to Access the Efficacy and Safety of Meloxicam in Patients With Osteoarthritis of the Knee
A Phase 4 study testing Meloxicam in people with Osteoarthritis, run by Boehringer Ingelheim.
Trial summary
To Access the Efficacy and Safety of Meloxicam 7.5mg once daily over a treatment period of 56 days Read more about this study
- Who is it for?
- Ages 34 to 74 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Meloxicam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Oct 1998to Feb 1999
- Phase
- Phase 4
- 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 34 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Osteoarthritis of the knee requiring the therapy with non-steroidal anti-inflammatory drugs (NSAIDs)
Who cannot join
- none
About this study
Official title: Open Study to Access the Efficacy and Safety of Meloxicam 7.5mg in Patients With Osteoarthritis of the Knee
To Access the Efficacy and Safety of Meloxicam 7.5mg once daily over a treatment period of 56 days
- Conditions
- Osteoarthritis
- Being tested
- Meloxicam
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MeloxicamDrug
Also called Mobic
| Study group | Role | What they receive |
|---|---|---|
| Meloxicam | Experimental | Not described Receives: Drug: Meloxicam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in pain on active movement assessed by a 100 mm visual analogue scale (100 mm, VAS)
Measured: Baseline, 8 weeks after first drug administration
Secondary outcomes (7)
Change from baseline in Lequesne index
Measured: Baseline, 8 weeks after first drug administration
Change from baseline in physical examination (tenderness)
Measured: Baseline, 8 weeks after first drug administration
Assessment of significant change from baseline in status according endoscopy
Measured: Baseline, 8 weeks after first drug administration
Assessment of significant change from baseline in gastrointestinal (GI) symptoms score
Measured: Baseline, 8 weeks after first drug administration
Assessment of significant change from baseline in laboratory values
Measured: Baseline, 8 weeks after first drug administration
Number of Patients with Adverse Events
Measured: Up to 8 weeks after first drug administration
Assessment of significant change from baseline in physical examination (swelling)
Measured: Baseline, 8 weeks after treatment
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 startOct 1998
- Primary completionFeb 1999
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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 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
- NCT02183116
- Sponsor's protocol ID
- 107.228
- Status last verified
- Jul 2014
- First submitted
- 4 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
- Open Study to Access the Efficacy and Safety of Meloxicam 7.5mg in Patients With Osteoarthritis of the Knee
- ClinicalTrials.gov ID
- NCT02183116
- Acronym / sponsor ID
- 107.228
- Conditions
- Osteoarthritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Oct 1998
- Primary completion
- Feb 1999 (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.
To Access the Efficacy and Safety of Meloxicam 7.5mg once daily over a treatment period of 56 days
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Meloxicam | Experimental | Drug: Meloxicam |
Who may qualify
- Ages
- 34 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Osteoarthritis of the knee requiring the therapy with non-steroidal anti-inflammatory drugs (NSAIDs)
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 |
|---|---|---|
| MeloxicamAlso: Mobic | Drug | Meloxicam |
Primary outcome
Change from baseline in pain on active movement assessed by a 100 mm visual analogue scale (100 mm, VAS)
Time frame: Baseline, 8 weeks after first drug administration
7 secondary outcomes
Change from baseline in Lequesne index
Time frame: Baseline, 8 weeks after first drug administration
Change from baseline in physical examination (tenderness)
Time frame: Baseline, 8 weeks after first drug administration
Assessment of significant change from baseline in status according endoscopy
Time frame: Baseline, 8 weeks after first drug administration
Assessment of significant change from baseline in gastrointestinal (GI) symptoms score
Time frame: Baseline, 8 weeks after first drug administration
Assessment of significant change from baseline in laboratory values
Time frame: Baseline, 8 weeks after first drug administration
Number of Patients with Adverse Events
Time frame: Up to 8 weeks after first drug administration
Assessment of significant change from baseline in physical examination (swelling)
Time frame: Baseline, 8 weeks after treatment
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?
A Phase 4 study testing Meloxicam in people with 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 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 from baseline in pain on active movement assessed by a 100 mm visual analogue scale (100 mm, VAS) (time frame: Baseline, 8 weeks after first drug administration). 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; AzTrials last refreshed its copy on 6 Nov 2026.