OsteoarthritisPhase 3NCT01801735

Study of Meloxicam Capsules in Subjects With Osteoarthritis of the Knee or Hip

A Phase 3 study testing Meloxicam Test Capsules in people with Osteoarthritis, run by Iroko Pharmaceuticals, LLC at 40 sites in United States.

Completed

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

Official record

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Trial summary

The purpose of this study is to evaluate the safety of Meloxicam SoluMatrix Capsules for up to 52 weeks in subjects with pain due to osteoarthritis (OA) of the knee or hip Read more about this study

Who is it for?: Ages 40 years and older
Conditions the study is for: Osteoarthritis
What is being tested?: Meloxicam Test Capsules
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 600 participants
Where: 40 sitesUnited States
Study dates: Mar 2013to Aug 2014
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 40 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Is male or female ≥ 40 years of age
If a participant in the previous MEL3-12-02 study, completed the study and did not discontinue for lack of efficacy or safety
Has a diagnosis of OA of the hip or knee with ongoing knee and/or articular hip pain
Chronic user of nonsteroidal anti-inflammatory drugs (NSAIDs) and/or acetaminophen for OA pain
If female and of childbearing potential, is nonlactating and nonpregnant

Who cannot join

History of allergic reaction or clinically significant intolerance to acetaminophen, aspirin, or any NSAIDs, including meloxicam
Requires continuous use of opioid or opioid combination products to control OA pain of the knee or hip
Clinically significant unstable cardiac, respiratory, neurological, immunological, hematological, or renal disease
Significant difficulties swallowing capsules or unable to tolerate oral medication
Has received any investigational drug (except Meloxicam SoluMatrix Capsules), device, or therapy within 30 days before Screening

Trial locations and contacts

40 sites in 1 country.

City, postcode or hospital

40 sites in 1 country

United States40 sites

Study site
Anderson, South Carolina, 29621
Study site
Austin, Texas, 78705
Study site
Birmingham, Alabama, 35216
Study site
Brockton, Massachusetts, 02301
Study site
Carmichael, California, 95608
Study site
Charlottesville, Virginia, 22911
Study site
Cincinnati, Ohio, 45219
Study site
Cincinnati, Ohio, 45227
Study site
Cincinnati, Ohio, 45255
Study site
Cincinnati, Ohio, 45256
Study site
Clinton, South Carolina, 29325
Study site
Columbus, Ohio, 43212
Study site
Crestview Hills, Kentucky, 41017
Study site
DeLand, Florida, 32720
Study site
Duncansville, Pennsylvania, 16635
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Fleming Island, Florida, 32003
Study site
Greensboro, North Carolina, 27408
Study site
Hartsdale, New York, 10530
Study site
Hazelwood, Missouri, 63042
Study site
Jacksonville, Florida, 32205
Study site
Jacksonville, Florida, 32216
Study site
Kettering, Ohio, 45429
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Las Vegas, Nevada, 89144
Study site
Miami, Florida, 33143
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Milford, Connecticut, 06460
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Newton, Kansas, 67114
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Omaha, Nebraska, 68134
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Ormond Beach, Florida, 32174
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Phoenix, Arizona, 85053
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Pismo Beach, California, 93449
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Plano, Texas, 75075
Study site
Ponte Vedra, Florida, 32081
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Prairie Village, Kansas, 66206
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Roanoke, Virginia, 24018
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San Antonio, Texas, 78209
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San Antonio, Texas, 78229
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St Louis, Missouri, 63141
Study site
Traverse City, Michigan, 49684
Study site
Troy, Michigan, 48098
Study site
Wichita, Kansas, 67203

Other trials in United States

About this study

Official title: A Multicenter, Open-Label, Safety Study of Meloxicam SoluMatrix™ Capsules in Subjects With Osteoarthritis of the Knee or Hip

The purpose of this study is to evaluate the safety of Meloxicam SoluMatrix Capsules for up to 52 weeks in subjects with pain due to osteoarthritis (OA) of the knee or hip

Conditions: Osteoarthritis
Being tested: Meloxicam Test Capsules
Medical subject headings: Osteoarthritis

What participants receive

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

Meloxicam Test CapsulesDrug

Study groups in NCT01801735
Study group	Role	What they receive
Meloxicam Test Capsules	Experimental	One Capsule QD Receives: Drug: Meloxicam Test Capsules

What is being measured

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

Safety of Meloxicam 10 mg as Assessed by the Incidence of Adverse Events From Baseline to Week 52 or Early Termination
The safety of Meloxicam 10 mg was assessed by the number of subjects with treatment-emergent adverse events (TEAEs), severe TEAEs, serious adverse events, treatment-related TEAEs, and adverse events (AEs) leading to discontinuation and subjects who died.
Measured: Baseline to Week 52/Early Termination

Timeline

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

Mar 2013Aug 2014

First posted1 Mar 2013 (estimated)
Study startMar 2013
Primary completionJun 2014
Study completionAug 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for OsteoarthritisStudies of the same condition, open and under way.
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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 600 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01801735
Sponsor's protocol ID: MEL3-12-03
Status last verified: Apr 2015
First submitted: 21 Feb 2013
Last updated: 12 May 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: 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?

See locations

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All Osteoarthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 12 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Open-Label, Safety Study of Meloxicam SoluMatrix™ Capsules in Subjects With Osteoarthritis of the Knee or Hip
ClinicalTrials.gov ID: NCT01801735
Acronym / sponsor ID: MEL3-12-03
Conditions: Osteoarthritis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 600 participants (actual)
Lead sponsor: Iroko Pharmaceuticals, LLCIndustry (pharma, biotech, devices)
Study start: Mar 2013
Primary completion: Jun 2014 (actual)
Study completion: Aug 2014 (actual)
First posted: 1 Mar 2013 (estimated)
Results: Posted 12 May 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to evaluate the safety of Meloxicam SoluMatrix Capsules for up to 52 weeks in subjects with pain due to osteoarthritis (OA) of the knee or hip

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Meloxicam Test Capsules	Experimental	Drug: Meloxicam Test CapsulesOne Capsule QD

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Is male or female ≥ 40 years of age
If a participant in the previous MEL3-12-02 study, completed the study and did not discontinue for lack of efficacy or safety
Has a diagnosis of OA of the hip or knee with ongoing knee and/or articular hip pain
Chronic user of nonsteroidal anti-inflammatory drugs (NSAIDs) and/or acetaminophen for OA pain
If female and of childbearing potential, is nonlactating and nonpregnant

Key exclusion criteria (5 listed)

History of allergic reaction or clinically significant intolerance to acetaminophen, aspirin, or any NSAIDs, including meloxicam
Requires continuous use of opioid or opioid combination products to control OA pain of the knee or hip
Clinically significant unstable cardiac, respiratory, neurological, immunological, hematological, or renal disease
Significant difficulties swallowing capsules or unable to tolerate oral medication
Has received any investigational drug (except Meloxicam SoluMatrix Capsules), device, or therapy within 30 days before Screening

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 Test Capsules	Drug	Meloxicam Test Capsules

Primary outcome

Safety of Meloxicam 10 mg as Assessed by the Incidence of Adverse Events From Baseline to Week 52 or Early Termination
Time frame: Baseline to Week 52/Early Termination
The safety of Meloxicam 10 mg was assessed by the number of subjects with treatment-emergent adverse events (TEAEs), severe TEAEs, serious adverse events, treatment-related TEAEs, and adverse events (AEs) leading to discontinuation and subjects who died.

Results and safety

Results posted to the registry on 12 May 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Meloxicam 10 mg	600	390

Primary outcome: Safety of Meloxicam 10 mg as Assessed by the Incidence of Adverse Events From Baseline to Week 52 or Early Termination

Time frame: Baseline to Week 52/Early Termination. Number. Unit: participants

Measure	Meloxicam 10 mg n = 600
Subjects with at least 1 TEAE	406
Subjects with at least 1 severe TEAE	23
Subjects with at least 1 serious adverse event	35
Subjects with at least 1 treatment-related TEAE	127
Subjects with AEs leading to discontinuation	79
Subjects who died	2

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Meloxicam 10 mg	35 of 600 (5.8%)	65 of 600 (10.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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.

40 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Meloxicam Test Capsules in people with Osteoarthritis, run by Iroko Pharmaceuticals, LLC at 40 sites in United States.

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 5 inclusion and 5 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 12 May 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Yes. Results are posted in the registry (first posted 12 May 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Safety of Meloxicam 10 mg as Assessed by the Incidence of Adverse Events From Baseline to Week 52 or Early Termination (time frame: Baseline to Week 52/Early Termination). 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 NCT01801735.

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 12 May 2015.