CompletedNCT01801735Updated May 12, 2015Results posted

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

A Phase 3 interventional study of Meloxicam Test Capsules in Osteoarthritis, sponsored by Iroko Pharmaceuticals, LLC. Completed at 40 sites in United States. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2015-05-12.

Sponsored by Iroko Pharmaceuticals, LLC · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 600
Allocation: Not applicable
Ages: 40 Years and older
Sex: All

Study 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

Conditions studied

Osteoarthritis

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In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

This study's enrollment of 600 is above the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

Iroko Pharmaceuticals, LLC is the lead sponsor of 13 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 40 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 600 participants (actual)

Study arms

Experimental
Meloxicam Test Capsules
One Capsule QD
Drug: Meloxicam Test Capsules

Interventions

DrugMeloxicam Test Capsules

What researchers measure

Primary outcomes

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.
Time frame: Baseline to Week 52/Early Termination

Results

Posted May 12, 2015

Participant flow

Participant flow — Overall Study
Milestone	Meloxicam 10 mg
Started	600
Completed	390
Not completed	210
Withdrew: Adverse event	79
Withdrew: Lack of efficacy	28
Withdrew: Withdrawal by subject	27
Withdrew: Protocol violation	25
Withdrew: Lost to follow-up	15
Withdrew: Non-compliance with trial drug	13
Withdrew: Physician decision	3
Withdrew: Death	1
Withdrew: Other, including site closure	19

Outcome measures

PrimarySafety 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.

Time frame:: Baseline to Week 52/Early Termination
Reported as:: Number · participants

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

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Meloxicam 10 mg	—	35/600 (5.8%)	65/600 (10.8%)

Most frequent serious events

Showing 10 of 38

Most frequent serious events
Event	Meloxicam 10 mg
Angina pectorisCardiac disorders	2/600
Non-cardiac chest painGeneral disorders	2/600
DiverticulitisInfections and infestations	2/600
Breast cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)	2/600
Renal failure acuteRenal and urinary disorders	2/600
Pulmonary embolismRespiratory, thoracic and mediastinal disorders	2/600
AnemiaBlood and lymphatic system disorders	1/600
Cardiac failure acuteCardiac disorders	1/600
Cardiac failure congestiveCardiac disorders	1/600
Coronary artery diseaseCardiac disorders	1/600

Most frequent other events

Most frequent other events
Event	Meloxicam 10 mg
ArthralgiaMusculoskeletal and connective tissue disorders	33/600
Urinary tract infectionInfections and infestations	33/600

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Meloxicam 10 mg
Mean	61.7 ± 8.68

Sex: Female, Male
Sex: Female, Male(Participants)	Meloxicam 10 mg
Female	358
Male	242

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Meloxicam 10 mg
Hispanic or Latino	33
Not Hispanic or Latino	567
Unknown or Not Reported	0

Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)	Meloxicam 10 mg
American Indian or Alaska Native	2
Asian	6
Black or African-American	73
Native Hawaiian or Other Pacific Islander	1
White	520

Weight
Weight(kg)	Meloxicam 10 mg
Mean	88.50 ± 18.28

Height
Height(cm)	Meloxicam 10 mg
Mean	169.56 ± 10.17

Body Mass Index
Body Mass Index(kg/m^2)	Meloxicam 10 mg
Mean	30.65 ± 5.02

Study locations

40 sites

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

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on May 12, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01801735
Lead sponsor: Iroko Pharmaceuticals, LLC
Responsible party: Sponsor
First posted: Mar 1, 2013
Start date: Mar 2013
Primary completion: Jun 2014
Completion: Aug 2014
Results posted: May 12, 2015
Last update: May 12, 2015

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.

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