Back to resultsStudy of Meloxicam Capsules in Subjects With Osteoarthritis of the Knee or Hip
Primary Purpose
Osteoarthritis
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Meloxicam Test Capsules
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Meloxicam Test Capsules
Arm Description
One Capsule QD
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01801735
First Posted
February 21, 2013
Last Updated
April 24, 2015
Sponsor
Iroko Pharmaceuticals, LLC
1. Study Identification
Unique Protocol Identification Number
NCT01801735
Brief Title
Study of Meloxicam Capsules in Subjects With Osteoarthritis of the Knee or Hip
Official Title
A Multicenter, Open-Label, Safety Study of Meloxicam SoluMatrix™ Capsules in Subjects With Osteoarthritis of the Knee or Hip
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
August 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Iroko Pharmaceuticals, LLC
4. Oversight
Data Monitoring Committee
No
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
600 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Meloxicam Test Capsules
Arm Type
Experimental
Arm Description
One Capsule QD
Intervention Type
Drug
Intervention Name(s)
Meloxicam Test Capsules
Primary Outcome Measure Information:
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35216
Country
United States
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85053
Country
United States
City
Carmichael
State/Province
California
ZIP/Postal Code
95608
Country
United States
City
Pismo Beach
State/Province
California
ZIP/Postal Code
93449
Country
United States
City
Milford
State/Province
Connecticut
ZIP/Postal Code
06460
Country
United States
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
City
Fleming Island
State/Province
Florida
ZIP/Postal Code
32003
Country
United States
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32205
Country
United States
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
City
Ponte Vedra
State/Province
Florida
ZIP/Postal Code
32081
Country
United States
City
Newton
State/Province
Kansas
ZIP/Postal Code
67114
Country
United States
City
Prairie Village
State/Province
Kansas
ZIP/Postal Code
66206
Country
United States
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67203
Country
United States
City
Crestview Hills
State/Province
Kentucky
ZIP/Postal Code
41017
Country
United States
City
Brockton
State/Province
Massachusetts
ZIP/Postal Code
02301
Country
United States
City
Traverse City
State/Province
Michigan
ZIP/Postal Code
49684
Country
United States
City
Troy
State/Province
Michigan
ZIP/Postal Code
48098
Country
United States
City
Hazelwood
State/Province
Missouri
ZIP/Postal Code
63042
Country
United States
City
St Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68134
Country
United States
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89144
Country
United States
City
Hartsdale
State/Province
New York
ZIP/Postal Code
10530
Country
United States
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27408
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45227
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45255
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45256
Country
United States
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43212
Country
United States
City
Kettering
State/Province
Ohio
ZIP/Postal Code
45429
Country
United States
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
City
Clinton
State/Province
South Carolina
ZIP/Postal Code
29325
Country
United States
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
City
Plano
State/Province
Texas
ZIP/Postal Code
75075
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78209
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22911
Country
United States
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24018
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study of Meloxicam Capsules in Subjects With Osteoarthritis of the Knee or Hip
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