Clinical trial NCT01801735: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoarthritis
Lead sponsor: Iroko Pharmaceuticals, LLC
Sponsor class: INDUSTRY
First posted: 2013-03-01
Enrollment: 600
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Safety of Meloxicam 10 mg as Assessed by the Incidence of Adverse Events From Baseline to Week 52 or Early Termination
timeFrame: Baseline to Week 52/Early Termination
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Phoenix
country: United States
state: Arizona
city: Carmichael
country: United States
state: California
city: Pismo Beach
country: United States
state: California
city: Milford
country: United States
state: Connecticut
city: DeLand
country: United States
state: Florida
city: Fleming Island
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Ormond Beach
country: United States
state: Florida
city: Ponte Vedra
country: United States
state: Florida
city: Newton
country: United States
state: Kansas
city: Prairie Village
country: United States
state: Kansas
city: Wichita
country: United States
state: Kansas
city: Crestview Hills
country: United States
state: Kentucky
city: Brockton
country: United States
state: Massachusetts
city: Traverse City
country: United States
state: Michigan
city: Troy
country: United States
state: Michigan
city: Hazelwood
country: United States
state: Missouri
city: St Louis
country: United States
state: Missouri
city: Omaha
country: United States
state: Nebraska
city: Las Vegas
country: United States
state: Nevada
city: Hartsdale
country: United States
state: New York
city: Greensboro
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Cincinnati
country: United States
state: Ohio
city: Cincinnati
country: United States
state: Ohio
city: Cincinnati
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Kettering
country: United States
state: Ohio
city: Duncansville
country: United States
state: Pennsylvania
city: Anderson
country: United States
state: South Carolina
city: Clinton
country: United States
state: South Carolina
city: Austin
country: United States
state: Texas
city: Plano
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Charlottesville
country: United States
state: Virginia
city: Roanoke
country: United States
state: Virginia
Study officials:
References: