OsteoarthritisPhase 4NCT02183129
Study to Assess the Efficacy and Safety of Meloxicam vs. Diclofenac SR in Patients With Osteoarthritis of the Knee
A Phase 4 study testing Diclofenac and Meloxicam in people with Osteoarthritis, run by Boehringer Ingelheim.
Trial summary
To assess the efficacy and safety of meloxicam 7.5mg once daily compared with diclofenac 100mg SR once daily over a treatment period of 8 weeks Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Diclofenac and Meloxicam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 1999to 1 Nov 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 18 years and older
- 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 Label Study to Assess the Efficacy and Safety of Meloxicam 7.5mg vs. Diclofenac 100mg SR in Patients With Osteoarthritis of the Knee
To assess the efficacy and safety of meloxicam 7.5mg once daily compared with diclofenac 100mg SR once daily over a treatment period of 8 weeks
- Conditions
- Osteoarthritis
- Being tested
- Diclofenac, Meloxicam
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiclofenacDrug
MeloxicamDrug
| Study group | Role | What they receive |
|---|---|---|
| Meloxicam | Experimental | Not described Receives: Drug: Meloxicam |
| Diclofenac | Active comparator | Not described Receives: Drug: Diclofenac |
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 (VAS)
Measured: Baseline, 8 weeks after first drug administration
Secondary outcomes (5)
Change from baseline in Lequesne index
Measured: Baseline, 8 weeks after first drug administration
Change from baseline in global assessment by the patient and doctor on a 3-point scale
Measured: Baseline, 8 weeks after first drug administration
Number of patients with significant changes from baseline in Laboratory values
Measured: Baseline, 8 weeks after first drug administration
Number of patients with significant changes from baseline in physical examinations
Measured: Baseline, 8 weeks after first drug administration
Number of patients with Adverse Events
Measured: Up to 8 weeks after first drug administration
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 start1 Apr 1999
- Primary completion1 Nov 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 91 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
- NCT02183129
- Sponsor's protocol ID
- 107.229
- Status last verified
- Nov 2023
- First submitted
- 4 Jul 2014
- Last updated
- 24 Nov 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label Study to Assess the Efficacy and Safety of Meloxicam 7.5mg vs. Diclofenac 100mg SR in Patients With Osteoarthritis of the Knee
- ClinicalTrials.gov ID
- NCT02183129
- Acronym / sponsor ID
- 107.229
- Conditions
- Osteoarthritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 1999 (actual)
- Primary completion
- 1 Nov 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 assess the efficacy and safety of meloxicam 7.5mg once daily compared with diclofenac 100mg SR once daily over a treatment period of 8 weeks
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Meloxicam | Experimental | Drug: Meloxicam |
| Diclofenac | Active comparator | Drug: Diclofenac |
Who may qualify
- Ages
- 18 years and older
- 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 |
|---|---|---|
| Diclofenac | Drug | Diclofenac |
| Meloxicam | Drug | Meloxicam |
Primary outcome
Change from baseline in pain on active movement assessed by a 100 mm visual analogue Scale (VAS)
Time frame: Baseline, 8 weeks after first drug administration
5 secondary outcomes
Change from baseline in Lequesne index
Time frame: Baseline, 8 weeks after first drug administration
Change from baseline in global assessment by the patient and doctor on a 3-point scale
Time frame: Baseline, 8 weeks after first drug administration
Number of patients with significant changes from baseline in Laboratory values
Time frame: Baseline, 8 weeks after first drug administration
Number of patients with significant changes from baseline in physical examinations
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
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 24 Nov 2023.
- Related InfoLink provided by the sponsor.
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Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
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Effect of Anti-inflammatory Diet in Osteoarthritis
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Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
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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 Diclofenac and 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 24 Nov 2023. 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 (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 24 Nov 2023.