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

• Sponsor: Iroko Pharmaceuticals, LLC (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01801735
• Collaborator: (none)
• Enrollment: 600
• Locations: 40
• Arm: 1
• Duration (Months): 17
• Patients Per Site: 15
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis	Drug: Meloxicam Test Capsules	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 600 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Multicenter, Open-Label, Safety Study of Meloxicam SoluMatrix™ Capsules in Subjects With Osteoarthritis of the Knee or Hip
• Study Start Date: Mar 1, 2013
• Actual Primary Completion Date: Jun 1, 2014
• Actual Study Completion Date: Aug 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Meloxicam Test Capsules One Capsule QD	Drug: Meloxicam Test Capsules

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years and Older
• Sexes Eligible for Study: 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:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Birmingham	Alabama	United States	35216
2		Phoenix	Arizona	United States	85053
3		Carmichael	California	United States	95608
4		Pismo Beach	California	United States	93449
5		Milford	Connecticut	United States	06460
6		DeLand	Florida	United States	32720
7		Fleming Island	Florida	United States	32003
8		Jacksonville	Florida	United States	32205
9		Jacksonville	Florida	United States	32216
10		Miami	Florida	United States	33143
11		Ormond Beach	Florida	United States	32174
12		Ponte Vedra	Florida	United States	32081
13		Newton	Kansas	United States	67114
14		Prairie Village	Kansas	United States	66206
15		Wichita	Kansas	United States	67203
16		Crestview Hills	Kentucky	United States	41017
17		Brockton	Massachusetts	United States	02301
18		Traverse City	Michigan	United States	49684
19		Troy	Michigan	United States	48098
20		Hazelwood	Missouri	United States	63042
21		St Louis	Missouri	United States	63141
22		Omaha	Nebraska	United States	68134
23		Las Vegas	Nevada	United States	89144
24		Hartsdale	New York	United States	10530
25		Greensboro	North Carolina	United States	27408
26		Cincinnati	Ohio	United States	45219
27		Cincinnati	Ohio	United States	45227
28		Cincinnati	Ohio	United States	45255
29		Cincinnati	Ohio	United States	45256
30		Columbus	Ohio	United States	43212
31		Kettering	Ohio	United States	45429
32		Duncansville	Pennsylvania	United States	16635
33		Anderson	South Carolina	United States	29621
34		Clinton	South Carolina	United States	29325
35		Austin	Texas	United States	78705
36		Plano	Texas	United States	75075
37		San Antonio	Texas	United States	78209
38		San Antonio	Texas	United States	78229
39		Charlottesville	Virginia	United States	22911
40		Roanoke	Virginia	United States	24018

Sponsors and Collaborators

• Iroko Pharmaceuticals, LLC

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Iroko Pharmaceuticals, LLC
• ClinicalTrials.gov Identifier: NCT01801735
• Other Study ID Numbers: MEL3-12-03
• First Posted: Mar 1, 2013
• Last Update Posted: May 12, 2015
• Last Verified: Apr 1, 2015

• Additional relevant MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Meloxicam

Study Results

Participant Flow

Arm/Group Title	Meloxicam 10 mg
Arm/Group Description	Participants were administered Meloxicam 10 mg once daily for up to 52 weeks.
Period Title: Overall Study
STARTED	600
COMPLETED	390
NOT COMPLETED	210

Baseline Characteristics

Arm/Group Title	Meloxicam 10 mg
Arm/Group Description	Participants were administered Meloxicam 10 mg once daily for up to 52 weeks.
Overall Participants	600
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	61.7 (8.68)
Sex: Female, Male (Count of Participants)
Female	358 59.7%
Male	242 40.3%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	33 5.5%
Not Hispanic or Latino	567 94.5%
Unknown or Not Reported	0 0%
Race/Ethnicity, Customized (participants) [Number]
American Indian or Alaska Native	2 0.3%
Asian	6 1%
Black or African-American	73 12.2%
Native Hawaiian or Other Pacific Islander	1 0.2%
White	520 86.7%
Weight (kg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg]	88.50 (18.28)
Height (cm) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [cm]	169.56 (10.17)
Body Mass Index (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	30.65 (5.02)

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Meloxicam 10 mg
Arm/Group Description	Participants were administered Meloxicam 10 mg once daily for up to 52 weeks.
Measure Participants	600
Subjects with at least 1 TEAE	406 67.7%
Subjects with at least 1 severe TEAE	23 3.8%
Subjects with at least 1 serious adverse event	35 5.8%
Subjects with at least 1 treatment-related TEAE	127 21.2%
Subjects with AEs leading to discontinuation	79 13.2%
Subjects who died	2 0.3%

Adverse Events

Arm/Group Title	Meloxicam 10 mg
Arm/Group Description	Participants were administered Meloxicam 10 mg once daily for up to 52 weeks.
All Cause Mortality
	Meloxicam 10 mg
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Meloxicam 10 mg
	Affected / at Risk (%)	# Events
Total	35/600 (5.8%)
Blood and lymphatic system disorders
Anemia	1/600 (0.2%)
Cardiac disorders
Angina pectoris	2/600 (0.3%)
Cardiac failure acute	1/600 (0.2%)
Cardiac failure congestive	1/600 (0.2%)
Coronary artery disease	1/600 (0.2%)
Coronary artery stenosis	1/600 (0.2%)
Gastrointestinal disorders
Diverticulum intestinal hemorrhagic	1/600 (0.2%)
Duodenal ulcer hemorrhage	1/600 (0.2%)
Gastric ulcer hemorrhage	1/600 (0.2%)
Gastroesophageal reflux disease	1/600 (0.2%)
General disorders
Chest pain	1/600 (0.2%)
Non-cardiac chest pain	2/600 (0.3%)
Hepatobiliary disorders
Drug-induced liver injury	1/600 (0.2%)
Infections and infestations
Appendicitis perforated	1/600 (0.2%)
Bronchitis	1/600 (0.2%)
Diverticulitis	2/600 (0.3%)
Lobar pneumonia	1/600 (0.2%)
Meningitis bacterial	1/600 (0.2%)
Sepsis	1/600 (0.2%)
Staphylococcal sepsis	1/600 (0.2%)
Injury, poisoning and procedural complications
Post procedural complication	1/600 (0.2%)
Road traffic accident	1/600 (0.2%)
Spinal compression fracture	1/600 (0.2%)
Musculoskeletal and connective tissue disorders
Costochondritis	1/600 (0.2%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer	2/600 (0.3%)
Lung squamous cell carcinoma, stage unspecified	1/600 (0.2%)
Transitional cell carcinoma	1/600 (0.2%)
Nervous system disorders
Carotid artery stenosis	1/600 (0.2%)
Hemorrhagic cerebral infarction	1/600 (0.2%)
Fourth nerve paralysis	1/600 (0.2%)
Renal and urinary disorders
Renal failure acute	2/600 (0.3%)
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome	1/600 (0.2%)
Acute respiratory failure	1/600 (0.2%)
Chronic obstructive pulmonary disease	1/600 (0.2%)
Pulmonary embolism	2/600 (0.3%)
Surgical and medical procedures
Medical device removal	1/600 (0.2%)
Vascular disorders
Aortic aneurysm rupture	1/600 (0.2%)
Hypertensive crisis	1/600 (0.2%)
Other (Not Including Serious) Adverse Events
	Meloxicam 10 mg
	Affected / at Risk (%)	# Events
Total	65/600 (10.8%)
Infections and infestations
Urinary tract infection	33/600 (5.5%)
Musculoskeletal and connective tissue disorders
Arthralgia	33/600 (5.5%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Investigator is required to submit any materials describing the results of the study at the site to sponsor for review not less than 30 days prior to publication and agrees to remove any of the Sponsor's confidential information. Sponsor also retains right to delay publication for an additional 60 day period to allow time for filing of patent applications.