Clinical trial NCT01787188: Study of Meloxicam Capsules to Treat Osteoarthritis Pain
Official title: A Phase 3, Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Fixed-Dose, Parallel-Group, Efficacy, and Safety Study of Meloxicam SoluMatrix™ Capsules in Patients With Pain Due to 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: 2013-02-08
Enrollment: 403
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether Meloxicam \[Test\] Capsules are safe and effective for the treatment of osteoarthritis pain of the knee or hip.


Eligibility criteria: Inclusion Criteria:

* Primary diagnosis of Functional Class I-III OA of the hip or knee
* Chronic user of nonsteroidal anti-inflammatory drugs (NDAIDs) and/or acetaminophen for OA pain
* Discontinued all analgesic therapy at Screening
* For women of child-bearing potential: a woman who is not pregnant and not nursing, and who is practicing an acceptable method of birth control

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
* Previous participation in another clinical study of Meloxicam Capsules or received any investigational drug or device or investigational therapy within 30 days before Screening

Primary outcomes:
measure: Change From Baseline to Week 12 After Trial Entry in Osteoarthritis Pain Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score.
timeFrame: Baseline to Week 12/Early Termination
Secondary outcomes:
measure: Change From Baseline to Week 2 After Trial Entry in Osteoarthritis Pain Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score.
timeFrame: Baseline to Week 2
measure: Change From Baseline to Week 6 After Trial Entry in Osteoarthritis Pain Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score.
timeFrame: Baseline to Week 6
measure: Change From Baseline to the Average of Weeks 2, 6, and 12 After Trial Entry in Osteoarthritis Pain Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score.
timeFrame: Baseline to Week 12/Early Termination
measure: Change From Baseline to Week 2 After Trial Entry in Osteoarthritis Pain, Stiffness, and Function Measured Using the Total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score.
timeFrame: Baseline to Week 2
measure: Change From Baseline to Week 6 After Trial Entry in Osteoarthritis Pain, Stiffness, and Function Measured Using the Total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score.
timeFrame: Baseline to Week 6
measure: Change From Baseline to Week 12 After Trial Entry in Osteoarthritis Pain, Stiffness, and Function Measured Using the Total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score.
timeFrame: Baseline to Week 12/Early Termination
measure: Change From Baseline to the Average of Weeks 2, 6, and 12 After Trial Entry in Osteoarthritis Pain, Stiffness, and Function Measured Using the Total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score.
timeFrame: Baseline to Week 12/Early Termination
measure: Change From Baseline to Week 2 After Trial Entry in Osteoarthritis Function Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Function Subscale Score.
timeFrame: Baseline to Week 2
measure: Change From Baseline to Week 6 After Trial Entry in Osteoarthritis Function Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Function Subscale Score.
timeFrame: Baseline to Week 6
measure: Change From Baseline to Week 12 After Trial Entry in Osteoarthritis Function Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Function Subscale Score.
timeFrame: Baseline to Week 12/Early Termination
measure: Change From Baseline to the Average of Weeks 2, 6, and 12 After Trial Entry in Osteoarthritis Function Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Function Subscale Score.
timeFrame: Baseline to Week 12/Early Termination
measure: Change From Baseline to Week 2 After Trial Entry in Osteoarthritis Stiffness Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score.
timeFrame: Baseline to Week 2
measure: Change From Baseline to Week 6 After Trial Entry in Osteoarthritis Stiffness Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score.
timeFrame: Baseline to Week 6
measure: Change From Baseline to Week 12 After Trial Entry in Osteoarthritis Stiffness Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score.
timeFrame: Baseline to Week 12/Early Termination
measure: Change From Baseline to the Average of Weeks 2, 6, and 12 After Trial Entry in Osteoarthritis Stiffness Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score.
timeFrame: Baseline to Week 12/Early Termination
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Achieve Clinical Research, LLC
state: Alabama
city: Carmichael
country: United States
facility: Medical Center
state: California
city: Pismo Beach
country: United States
facility: Arroyo Medical Group, Inc
state: California
city: Milford
country: United States
facility: Clinical Research Consulting
state: Connecticut
city: DeLand
country: United States
facility: Avail Clinical Research
state: Florida
city: Fleming Island
country: United States
facility: Fleming Island Center for Clinical Research
state: Florida
city: Jacksonville
country: United States
facility: Westside Center for Clinical Research
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Center for Clinical Research
state: Florida
city: Miami
country: United States
facility: Well Pharma Medical Research Corporation
state: Florida
city: Ormond Beach
country: United States
facility: Peninsula Research, Inc
state: Florida
city: Ponte Vedra
country: United States
facility: St Johns Center for Clinical Research
state: Florida
city: Newton
country: United States
facility: Heartland Research Associates, LLC
state: Kansas
city: Prairie Village
country: United States
facility: Clinical Trials Technology Inc
state: Kansas
city: Wichita
country: United States
facility: Professional Research Network of Kansas, LLC
state: Kansas
city: Crestview Hills
country: United States
facility: Community Research
state: Kentucky
city: Brockton
country: United States
facility: Beacon Clinical Research, LLC
state: Massachusetts
city: Traverse City
country: United States
facility: Medical Research Associates, Inc
state: Michigan
city: Troy
country: United States
facility: Troy Internal Medicine, PC / Research Department
state: Michigan
city: Hazelwood
country: United States
facility: Healthcare Research
state: Missouri
city: St Louis
country: United States
facility: Sundance Clinical Research, LLC
state: Missouri
city: Omaha
country: United States
facility: Heartland Clinical Research, Inc
state: Nebraska
city: Omaha
country: United States
facility: Meridian Clinical Research
state: Nebraska
city: Las Vegas
country: United States
facility: Office of Matthew Barton, MD
state: Nevada
city: Hartsdale
country: United States
facility: Drug Trials America
state: New York
city: Greensboro
country: United States
facility: Triad Clinical Research
state: North Carolina
city: Cincinnati
country: United States
facility: Sterling Research Group, Ltd
state: Ohio
city: Cincinnati
country: United States
facility: Community Research
state: Ohio
city: Cincinnati
country: United States
facility: Sterling Research Group, Ltd
state: Ohio
city: Cincinnati
country: United States
facility: Community Research - Anderson
state: Ohio
city: Columbus
country: United States
facility: Radiant Research, Inc
state: Ohio
city: Kettering
country: United States
facility: Wells Institute for Health Awareness
state: Ohio
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: Anderson
country: United States
facility: Radiant Research, Inc
state: South Carolina
city: Clinton
country: United States
facility: Palmetto Clinical Trial Services, LLC
state: South Carolina
city: Austin
country: United States
facility: Premier Research - Austin
state: Texas
city: Plano
country: United States
facility: Clinical Investigations of Texas, LLC
state: Texas
city: San Antonio
country: United States
facility: Quality Research Inc
state: Texas
city: San Antonio
country: United States
facility: Diagnostics Research Group
state: Texas
city: Charlottesville
country: United States
facility: Charlottesville Medical Research Center, LLC
state: Virginia
city: Roanoke
country: United States
facility: Hypothetest, LLC
state: Virginia
Study officials:
affiliation: Diagnostics Research Group
name: Charles P Andrews, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Well Pharma Medical Research Corporation
name: Eddie Armas, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Office of Matthew Barton, MD
name: Matthew Barton, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Heartland Clinical Research, Inc
name: David Bouda, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical Center
name: John Champlin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Beacon Clinical Research, LLC
name: David Chen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical Investigations of Texas, LLC
name: Melanie Christina, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Charlottesville Medical Research Center, LLC
name: James R Clark, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Premier Research Group - Austin
name: Stephen Daniels, DO
role: PRINCIPAL_INVESTIGATOR
affiliation: Hypothetest, LLC
name: Richard R Eckert, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Meridian Clinical Research
name: Brandon Essink, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fleming Island Center for Clinical Research
name: John Flinchbaugh, DO
role: PRINCIPAL_INVESTIGATOR
affiliation: Troy Internal Medicine, PC / Research Department
name: Neil Fraser, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Heartland Research Associates, LLC
name: Richard M Glover, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Avail Clinical Research
name: John M Hill, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Quality Research Inc
name: Curtis S Horn, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Jacksonville Center For Clinical Research
name: Jeffry Jacqmein, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Triad Clinical Research
name: Richard Montgomery, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Altoona Center for Clinical Research
name: Alan Kivitz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Radiant Research, Inc
name: James Kopp, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Professional Research Network of Kansas, LLC
name: Gregory F Lakin, DO
role: PRINCIPAL_INVESTIGATOR
affiliation: Drug Trials America
name: Sathish Modugu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sterling Research Group, Ltd
name: Julie Mullen, DO
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical Research Associates, Inc
name: Thomas Nussdorfer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wells Institute for Health Awareness
name: Naynesh Patel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Peninsula Research, Inc
name: Kashyap Patel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Community Research
name: Stephen J Poland, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Healthcare Research
name: Larry D Reed, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Johns Center for Clinical Research
name: Erich Schramm, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Radiant Research, Inc
name: Douglas R Schumacher, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Palmetto Clinical Trial Services, LLC
name: Louis Stephens, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Westside Center for Clinical Research
name: Mark Stich, DO
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical Trials Technology Inc
name: Haydn M Thomas, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical Research Consulting
name: Susann Varano, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sundance Clinical Research, LLC
name: Larkin T Wadsworth, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Community Research
name: Robert J Wagner, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sterling Research Group, Ltd
name: Matthew A Wenker, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Achieve Clinical Research, LLC
name: Hayes T Williams, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Community Research
name: James Maynard, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Arroyo Medical Group, Inc
name: Roger Guthrie, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Altman R, Hochberg M, Gibofsky A, Jaros M, Young C. Efficacy and safety of low-dose SoluMatrix meloxicam in the treatment of osteoarthritis pain: a 12-week, phase 3 study. Curr Med Res Opin. 2015 Dec;31(12):2331-43. doi: 10.1185/03007995.2015.1112772.