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

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

Study Overview

• Status: Completed
• Conditions: Osteoarthritis
• Intervention / Treatment: Drug: Meloxicam Test Capsules

• Study Type: Interventional
• Enrollment (Actual): 600
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Meloxicam Test Capsules; One Capsule QD	Drug: Meloxicam Test Capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline to Week 52/Early Termination

Collaborators and Investigators

• Sponsor: Iroko Pharmaceuticals, LLC

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (ACTUAL): June 1, 2014
• Study Completion (ACTUAL): August 1, 2014

Study Registration Dates

• First Submitted: February 21, 2013
• First Submitted That Met QC Criteria: February 27, 2013
• First Posted (ESTIMATE): March 1, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): May 12, 2015
• Last Update Submitted That Met QC Criteria: April 24, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Cyclooxygenase 2 Inhibitors; Meloxicam
• Other Study ID Numbers: MEL3-12-03