Clinical trial NCT01510912: Open-Label Study of Diclofenac Capsules to Treat Osteoarthritis Pain
Official title: A Multicenter, Open-Label, 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: 2012-01-18
Enrollment: 602
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 Diclofenac \[Test\] Capsules for the treatment of osteoarthritis pain of the knee or hip.


Eligibility criteria: Inclusion Criteria:

* Male or female ≥ \[greater than or equal to\] 40 years of age
* If a participant in the previous DIC3-08-05 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
* Is a current chronic user of nonsteroidal anti-inflammatory drugs (NSAIDs) and/or acetaminophen for his/her OA pain and is anticipated to benefit from continuous treatment with therapeutic doses of NSAIDs. A current chronic user is defined as a subject who has used these treatments for ≥ \[greater than or equal to\] 20 days of the last 30 days before screening

Exclusion Criteria:

* Has a known history of allergic reaction or clinically significant intolerance to acetaminophen, aspirin, or any nonsteroid anti-inflammatory drugs (NSAIDs), including diclofenac
* Requires chronic use of opioid or opioid combination products to control OA pain of the knee or hip
* Has any clinically significant unstable cardiac, respiratory, neurological, immunological, hematological, or renal disease
* Has significant difficulties swallowing capsules or is unable to tolerate oral medication

Primary outcomes:
measure: Safety of Diclofenac 35 mg Capsules 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:
measure: Mean Short Form-36 Physical Component Summary Scores at Week 52/Early Termination (ET) and Change From Baseline to Week 52/ET
timeFrame: Baseline to Week 52/Early Termination
measure: Mean Short Form-36 Mental Component Summary Scores at Week 52/Early Termination (ET) and Change From Baseline to Week 52/ET
timeFrame: Baseline to Week 52/Early Termination
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 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
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
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: 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
affiliation: Drug Studies America
name: Marvin Tark, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Altman RD, Strand V, Hochberg MC, Gibofsky A, Markenson JA, Hopkins WE, Cryer B, Kivitz A, Nezzer J, Imasogie O, Young CL. Low-dose SoluMatrix diclofenac in the treatment of osteoarthritis: A 1-year, open-label, Phase III safety study. Postgrad Med. 2015 Jun;127(5):517-28. doi: 10.1080/00325481.2015.1040716. Epub 2015 Apr 27.