Clinical trial NCT01461369: Study of Diclofenac Capsules to Treat Osteoarthritis Pain
Official title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Fixed-Dose, Parallel-Group, Efficacy and Safety Study of Diclofenac [Test] 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: 2011-10-28
Enrollment: 305
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 Diclofenac \[Test\] Capsules are safe and effective for the treatment of osteoarthritis pain of the hip or knee.


Eligibility criteria: Inclusion Criteria:

* Primary diagnosis of Functional Class I-III OA of the hip or knee with documented osteoarthritis flare at baseline
* Chronic user of nonsteroidal anti-inflammatory drugs (NSAIDs) 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 diclofenac
* 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 Diclofenac 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 the Average of Weeks 2, 6, and 12 After Trial Entry in Osteoarthritis Pain, Stiffness, and Function Measured Using the Total (Composite) 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 Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale.
timeFrame: Baseline to Week 12/Early Termination
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Premier Research Group - Phoenix
state: Arizona
city: Little Rock
country: United States
facility: Lynn Institute of the Ozarks
state: Arkansas
city: Anaheim
country: United States
facility: Acri-Phase I, LLC
state: California
city: Carmichael
country: United States
facility: Med Center
state: California
city: Colorado Springs
country: United States
facility: Expresscare Clinical Research
state: Colorado
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: Winter Park
country: United States
facility: Alliance Clinical Research
state: Florida
city: Atlanta
country: United States
facility: Pinnacle Trials, Inc
state: Georgia
city: Marietta
country: United States
facility: Drug Studies America
state: Georgia
city: Gurnee
country: United States
facility: Clinical Investigation Specialists, Inc
state: Illinois
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: Bingham Farms
country: United States
facility: Quest Research Institute
state: Michigan
city: Florissant
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: Asheville
country: United States
facility: Clinical Study Center of Asheville, LLC
state: North Carolina
city: Greensboro
country: United States
facility: Triad Clinical Research
state: North Carolina
city: High Point
country: United States
facility: Peters Medical 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: Community Research
state: Ohio
city: Cincinnati
country: United States
facility: Sterling Research Group, Ltd
state: Ohio
city: Columbus
country: United States
facility: Radiant Research, Inc
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: Austin
country: United States
facility: Premier Research Group - 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: Progressive Clinical Research
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: Clinical Investigation Specialists, Inc
name: John M Agaiby, 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: Peters Medical Research
name: Venkata Challa, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Med Center
name: John Champlin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Pinnacle Trials, Inc
name: Francisco Chevres, 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: Heartland Research Associates, LLC
name: Richard M Glover, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Alliance Clinical Research
name: Kent S Hoffman, DO
role: PRINCIPAL_INVESTIGATOR
affiliation: Quality Research Inc
name: Curtis S Horn, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Quest Research Institute
name: Raymond E Jackson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Jacksonville Center For Clinical Research
name: Jeffry Jacqmein, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Triad Clinical Research
name: Enrico Jones, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Altoona Center for Clinical Research
name: Alan Kivitz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: ACRI-Phase I, LLC
name: Kevin Kuettel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Professional Research Network of Kansas, LLC
name: Gregory F Lakin, DO
role: PRINCIPAL_INVESTIGATOR
affiliation: Progressive Clinical Research
name: Theresia Lee, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Drug Trials America
name: Sathish Modugu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sterling Research Group, Ltd
name: Julie A Mullen, DO
role: PRINCIPAL_INVESTIGATOR
affiliation: Peninsula Research, Inc
name: Kashyap Patel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Premier Research Group - Phoenix
name: Kyle Patrick, DO
role: PRINCIPAL_INVESTIGATOR
affiliation: Community Research
name: Antoinette A Pragalos, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Healthcare Research
name: Larry D Reed, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sterling Research Group, Ltd
name: Eli M Roth, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Radiant Research, Inc
name: Douglas R Schumacher, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Westside Center for Clinical Research
name: Mark Stich, DO
role: PRINCIPAL_INVESTIGATOR
affiliation: Radiant Research, Inc
name: Bradley Swenson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Drug Studies America
name: Marvin Tark, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Expresscare Clinical Research
name: Gary Tarshis, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical Trials Technology Inc
name: Haydn M Thomas, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical Study Center of Asheville, LLC
name: Cindy Tuten, 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: Lynn Institute of the Ozarks
name: Larry S Watkins, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Community Research
name: Tamela Zimmerman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gibofsky A, Hochberg MC, Jaros MJ, Young CL. Efficacy and safety of low-dose submicron diclofenac for the treatment of osteoarthritis pain: a 12 week, phase 3 study. Curr Med Res Opin. 2014 Sep;30(9):1883-93. doi: 10.1185/03007995.2014.946123. Epub 2014 Aug 6.