Study to Compare Prescription Non-Steroidal Anti-Inflammatory Drug (NSAID) Changes, Health Care Utilization, Efficacy and Safety of Meloxicam 7.5 mg Versus Usual Care Administration of Prescription NSAIDs in a Managed Healthcare Setting in Patients With Osteoarthritis

A Phase 3 study testing Meloxicam and NSAID in people with Osteoarthritis, run by Boehringer Ingelheim.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Study to compare the percentage of treatment successes or failures in patients randomized to meloxicam 7.5 mg vs. usual care prescription NSAIDs. Additionally, health care utilization, efficacy and safety of patients in a managed healthcare setting with osteoarthritis (OA) of the hip, knee, hand or spine will be… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Osteoarthritis
What is being tested?: Meloxicam and NSAID
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,309 participants
Where: No sites listed yet
Study dates: Oct 1998to Nov 2000
Phase: Phase 3
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

Males and females over the age of 18
The patient, if female and of reproductive potential (i.e. neither surgically sterilized nor post-menopausal), must be practicing adequate contraception (e.g. intrauterine device, contraceptive pills, Depo-Provera, or implant or double barrier device) for at least three months prior to and for the duration of their trial participation and must have a negative pregnancy test at screening. Abstinence is not considered to be an acceptable method of contraception. (It should be noted that NSAIDs might interfere with the effectiveness of intrauterine devices)
The patient must have a documented diagnosis of at least one of the following:
Osteoarthritis of the hip
Osteoarthritis of the knee
Osteoarthritis of the hand or

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Osteoarthritis of the spine - Patients must have radiographic confirmation of the diagnosis
The patient is willing to change or requires a change in current prescription NSAID therapy or requires initiation of prescription NSAID therapy for treatment of OA of the hip, knee, hand or spine
The patient intends to remain a member of their present Managed Care Organization (MCO) for the duration of the trial
The patient is willing to comply with instructions and to provide written informed consent

Who cannot join

The patient has a known or suspected hypersensitivity to the trial drugs or their excipients, analgesics, antipyretics or NSAIDS (prescription or over-the-counter)
The patient has received an investigational drug or used an investigational device within 30 days prior to entering the trial
In the opinion of the investigator the patient has any disease or condition that may result in altered absorption, excess accumulation or impaired metabolism or excretion of the trial medication
The patient has a history of recurrent peptic ulcer or history (within the past 6 months) of gastrointestinal perforation, peptic ulceration documented by endoscopy or radiography, symptomatic hiatal hernia requiring daily treatment or any history of a gastrointestinal tract hemorrhage, except simple hemorrhoidal bleeding
The patient is currently on coumadin or might be placed on coumadin during the course of the clinical trial
Patients with dementia, i.e. incapable of following directions or complying with the study protocol

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Patients with co-existing rheumatological disorders including rheumatoid arthritis
The patient has previously participated in this trial
Patients with coexisting fibromyalgia or ankylosing spondylitis
Patient is pregnant or lactating
Patient has severe hepatic failure
Patient has non-dialysed renal failure
Patient has history of GI bleed within the past 6 months
Patient has history of cerebrovascular bleeding or other bleeding disorders
Patient is receiving concomitant lithium, heparin or ticlopidine therapy
Patient has a history of leukopenia (White Blood Cell count < 3500/mm³)
The patient has a history of platelet count below the lower limit of normal or has a documented abnormal prothrombin time (PT) or partial thromboplastin time (PTT)

About this study

Official title: A Multi-Center, Randomized, Parallel-Group, Open-Label Study to Compare Prescription Non-Steroidal Anti-Inflammatory Drug (NSAID) Changes, Health Care Utilization, Efficacy and Safety of Meloxicam 7.5 mg Versus Usual Care Administration of Prescription NSAIDs in a Managed Healthcare Setting in Patients With Osteoarthritis of the Hip, Knee, Hand or Spine

Conditions: Osteoarthritis
Being tested: Meloxicam, NSAID
Medical subject headings: Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MeloxicamDrug
NSAIDDrug

Study groups in NCT02183064
Study group	Role	What they receive
Meloxicam	Experimental	Not described Receives: Drug: Meloxicam
Usual care prescription NSAID	Active comparator	Not described Receives: Drug: NSAID

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of treatment successes and failures in patients randomized to meloxicam 7.5 mg vs.usual care prescription NSAIDs
Measured: up to 6 month

Secondary outcomes (11)

Investigator's Global Assessment of Disease Activity (Likert)
Measured: Screening (Day 0), after six month (Day 180)
Patient's overall Assessment of pain over the past week on a visual analogue scale (VAS)
Measured: Day 0, 30, 60, 90, 120, 150, 180
Patient's Assessment of Health Status (VAS)
Measured: Day 0, 30, 60, 90, 120, 150, 180
Patient's Assessment of Satisfaction of Health
Measured: Day 0, 30, 60, 90, 120, 150, 180
Utility Index (VAS)
Measured: Day 0, 30, 60, 90, 120, 150, 180
Western Ontario and Mc Master University Osteoarthritis Index (WOMAC)
Measured: Day 0, 30, 60, 90, 120, 150, 180
Medication Compliance
Measured: Day 30, day 180
Disability Index
Measured: Screening (Day 0), after six month (Day 180)
Permanent Discontinuation of Study Medication related to lack of efficacy
Measured: up to day 180
Incidence and intensity of adverse events
Measured: from day 30 until day 180
Permanent Discontinuation of Study Medication related to adverse event
Measured: from day 30 until day 180

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 1998Nov 2000

First posted8 Jul 2014 (estimated)
Study startOct 1998
Primary completionNov 2000

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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 1,309 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02183064
Sponsor's protocol ID: 107.210
Status last verified: Jul 2014
First submitted: 4 Jul 2014
Last updated: 8 Jul 2014
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Holistic Healing for Knee Osteoarthritis
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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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All Osteoarthritis trials

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: A Multi-Center, Randomized, Parallel-Group, Open-Label Study to Compare Prescription Non-Steroidal Anti-Inflammatory Drug (NSAID) Changes, Health Care Utilization, Efficacy and Safety of Meloxicam 7.5 mg Versus Usual Care Administration of Prescription NSAIDs in a Managed Healthcare Setting in Patients With Osteoarthritis of the Hip, Knee, Hand or Spine
ClinicalTrials.gov ID: NCT02183064
Acronym / sponsor ID: 107.210
Conditions: Osteoarthritis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,309 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Oct 1998
Primary completion: Nov 2000 (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.

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
Usual care prescription NSAID	Active comparator	Drug: NSAID

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Males and females over the age of 18
The patient, if female and of reproductive potential (i.e. neither surgically sterilized nor post-menopausal), must be practicing adequate contraception (e.g. intrauterine device, contraceptive pills, Depo-Provera, or implant or double barrier device) for at least three months prior to and for the duration of their trial participation and must have a negative pregnancy test at screening. Abstinence is not considered to be an acceptable method of contraception. (It should be noted that NSAIDs might interfere with the effectiveness of intrauterine devices)
The patient must have a documented diagnosis of at least one of the following:
The patient is willing to change or requires a change in current prescription NSAID therapy or requires initiation of prescription NSAID therapy for treatment of OA of the hip, knee, hand or spine
The patient intends to remain a member of their present Managed Care Organization (MCO) for the duration of the trial

Key exclusion criteria (17 listed)

The patient has a known or suspected hypersensitivity to the trial drugs or their excipients, analgesics, antipyretics or NSAIDS (prescription or over-the-counter)
The patient has received an investigational drug or used an investigational device within 30 days prior to entering the trial
In the opinion of the investigator the patient has any disease or condition that may result in altered absorption, excess accumulation or impaired metabolism or excretion of the trial medication
The patient has a history of recurrent peptic ulcer or history (within the past 6 months) of gastrointestinal perforation, peptic ulceration documented by endoscopy or radiography, symptomatic hiatal hernia requiring daily treatment or any history of a gastrointestinal tract hemorrhage, except simple hemorrhoidal bleeding
The patient is currently on coumadin or might be placed on coumadin during the course of the clinical trial

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
NSAID	Drug	Usual care prescription NSAID

Primary outcome

Percentage of treatment successes and failures in patients randomized to meloxicam 7.5 mg vs.usual care prescription NSAIDs
Time frame: up to 6 month

11 secondary outcomes

Investigator's Global Assessment of Disease Activity (Likert)
Time frame: Screening (Day 0), after six month (Day 180)
Patient's overall Assessment of pain over the past week on a visual analogue scale (VAS)
Time frame: Day 0, 30, 60, 90, 120, 150, 180
Patient's Assessment of Health Status (VAS)
Time frame: Day 0, 30, 60, 90, 120, 150, 180
Patient's Assessment of Satisfaction of Health
Time frame: Day 0, 30, 60, 90, 120, 150, 180
Utility Index (VAS)
Time frame: Day 0, 30, 60, 90, 120, 150, 180
Western Ontario and Mc Master University Osteoarthritis Index (WOMAC)
Time frame: Day 0, 30, 60, 90, 120, 150, 180
Medication Compliance
Time frame: Day 30, day 180
Disability Index
Time frame: Screening (Day 0), after six month (Day 180)
Permanent Discontinuation of Study Medication related to lack of efficacy
Time frame: up to day 180
Incidence and intensity of adverse events
Time frame: from day 30 until day 180
Permanent Discontinuation of Study Medication related to adverse event
Time frame: from day 30 until day 180

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 trials for Osteoarthritis

Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee

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 3 study testing Meloxicam and NSAID 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 10 inclusion and 17 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Percentage of treatment successes and failures in patients randomized to meloxicam 7.5 mg vs.usual care prescription NSAIDs (time frame: up to 6 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02183064.

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.