Open-Label Study of Diclofenac Capsules to Treat Osteoarthritis Pain

NCT01510912 | Completed Phase 3 Results

• 1 other identifier: DIC3-08-06
• Study Type: interventional
• Target: 602
• Locations: 1 country
• Sites: 40

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.

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Safety of Diclofenac 35 mg Capsules as Assessed by the Incidence of Adverse Events From Baseline to Week 52 or Early Termination

  The safety of Diclofenac 35 mg capsules was assessed by the number of subjects with treatment-emergent adverse events (TEAEs), severe TEAEs, and serious adverse events.

  Baseline to Week 52/Early Termination

Other Outcomes (2)

• Mean Short Form-36 Physical Component Summary Scores at Week 52/Early Termination (ET) and Change From Baseline to Week 52/ET

  Baseline to Week 52/Early Termination

• Mean Short Form-36 Mental Component Summary Scores at Week 52/Early Termination (ET) and Change From Baseline to Week 52/ET

  Baseline to Week 52/Early Termination

Study Arms (1)

Diclofenac Capsules 35 mg bid or tid

EXPERIMENTAL

Drug: Diclofenac

Interventions

Diclofenac DRUG

35 mg bid or tid Capsules

Diclofenac Capsules 35 mg bid or tid

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Iroko Pharmaceuticals, LLC: lead

Study Sites (40)

Premier Research Group - Phoenix

Phoenix, Arizona, 85027, United States

Location

Lynn Institute of the Ozarks

Little Rock, Arkansas, 72205, United States

Location

Acri-Phase I, LLC

Anaheim, California, 92801, United States

Location

Med Center

Carmichael, California, 95608, United States

Location

Expresscare Clinical Research

Colorado Springs, Colorado, 80909, United States

Location

Westside Center for Clinical Research

Jacksonville, Florida, 32205, United States

Location

Jacksonville Center for Clinical Research

Jacksonville, Florida, 32216, United States

Location

Well Pharma Medical Research, Corporation

Miami, Florida, 33143, United States

Location

Peninsula Research, Inc

Ormond Beach, Florida, 32174, United States

Location

Alliance Clinical Research

Winter Park, Florida, 32792, United States

Location

Pinnacle Trials, Inc

Atlanta, Georgia, 30329, United States

Location

Drug Studies America

Marietta, Georgia, 30060, United States

Location

Clinical Investigation Specialists, Inc

Gurnee, Illinois, 60031, United States

Location

Heartland Research Associates, LLC

Newton, Kansas, 67114, United States

Location

Clinical Trials Technology Inc

Prairie Village, Kansas, 66206, United States

Location

Professional Research Network of Kansas, LLC

Wichita, Kansas, 67203, United States

Location

Community Research

Crestview Hills, Kentucky, 41017, United States

Location

Quest Research Institute

Bingham Farms, Michigan, 48025, United States

Location

Healthcare Research

Florissant, Missouri, 63031, United States

Location

Sundance Clinical Research, LLC

St Louis, Missouri, 63141, United States

Location

Heartland Clinical Research, Inc

Omaha, Nebraska, 68134, United States

Location

Meridian Clinical Research

Omaha, Nebraska, 68134, United States

Location

Office of Matthew Barton, MD

Las Vegas, Nevada, 89106, United States

Location

Drug Trials America

Hartsdale, New York, 10530, United States

Location

Clinical Study Center of Asheville, LLC

Asheville, North Carolina, 28803, United States

Location

Triad Clinical Research

Greensboro, North Carolina, 27408, United States

Location

Peters Medical Research

High Point, North Carolina, 27262, United States

Location

Sterling Research Group, Ltd

Cincinnati, Ohio, 45219, United States

Location

Community Research

Cincinnati, Ohio, 45227, United States

Location

Community Research

Cincinnati, Ohio, 45245, United States

Location

Sterling Research Group, Ltd

Cincinnati, Ohio, 45246, United States

Location

Radiant Research, Inc

Columbus, Ohio, 43212, United States

Location

Altoona Center for Clinical Research

Duncansville, Pennsylvania, 16635, United States

Location

Radiant Research, Inc

Anderson, South Carolina, 29621, United States

Location

Premier Research Group - Austin

Austin, Texas, 78705, United States

Location

Clinical Investigations of Texas, LLC

Plano, Texas, 75075, United States

Location

Quality Research Inc

San Antonio, Texas, 78209, United States

Location

Progressive Clinical Research

San Antonio, Texas, 78229, United States

Location

Charlottesville Medical Research Center, LLC

Charlottesville, Virginia, 22911, United States

Location

Hypothetest, LLC

Roanoke, Virginia, 24018, United States

Location

Related Publications (1)

• 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.

  PMID: 25913498 DERIVED

MeSH Terms

Conditions

Osteoarthritis

Interventions

Diclofenac

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Results Point of Contact

• Title: Daniel Solorio, Executive Director of Clinical Operations
• Organization: Iroko Pharmaceuticals, LLC

dsolorio@iroko.com

267-546-3150

Study Officials

• John M Agaiby, MD

  Clinical Investigation Specialists, Inc

  PRINCIPAL INVESTIGATOR

• Eddie Armas, MD

  Well Pharma Medical Medical Research, Corporation

  PRINCIPAL INVESTIGATOR

• Matthew Barton, MD

  Office of Matthew Barton, MD

  PRINCIPAL INVESTIGATOR

• David Bouda, MD

  Heartland Clinical Research

  PRINCIPAL INVESTIGATOR

• Venkata Challa, MD

  Peters Medical Research

  PRINCIPAL INVESTIGATOR

• John Champlin, MD

  Med Center

  PRINCIPAL INVESTIGATOR

• Francisco Chevres, MD

  Pinnacle Trials, Inc

  PRINCIPAL INVESTIGATOR

• Melanie Christina, MD

  Clinical Investigations of Texas, LLC

  PRINCIPAL INVESTIGATOR

• James R Clark, MD

  Charlottesville Medical Research Center, LLC

  PRINCIPAL INVESTIGATOR

• Stephen Daniels, DO

  Premier Research Group - Austin

  PRINCIPAL INVESTIGATOR

• Richard R Eckert, MD

  Hypothetest, LLC

  PRINCIPAL INVESTIGATOR

• Brandon Essink, MD

  Meridian Clinical Research

  PRINCIPAL INVESTIGATOR

• Richard M Glover, MD

  Heartland Research Associates, LLC

  PRINCIPAL INVESTIGATOR

• Kent S Hoffman, DO

  Alliance Clinical Research

  PRINCIPAL INVESTIGATOR

• Curtis S Horn, MD

  Quality Research Inc

  PRINCIPAL INVESTIGATOR

• Raymond E Jackson, MD

  Quest Research Institute

  PRINCIPAL INVESTIGATOR

• Jeffry Jacqmein, MD

  Jacksonville Center For Clinical Research

  PRINCIPAL INVESTIGATOR

• Enrico Jones, MD

  Triad Clinical Research

  PRINCIPAL INVESTIGATOR

• Alan Kivitz, MD

  Altoona Center for Clinical Research

  PRINCIPAL INVESTIGATOR

• Kevin Kuettel, MD

  Acri-Phase I, LLC

  PRINCIPAL INVESTIGATOR

• Gregory F Lakin, DO

  Professional Research Network of Kansas, LLC

  PRINCIPAL INVESTIGATOR

• Theresia Lee, MD

  Progressive Clinical Research

  PRINCIPAL INVESTIGATOR

• Sathish Modugu, MD

  Drug Trials America

  PRINCIPAL INVESTIGATOR

• Julie A Mullen, DO

  Sterling Research Group, Ltd

  PRINCIPAL INVESTIGATOR

• Kashyap Patel, MD

  Peninsula Research, Inc

  PRINCIPAL INVESTIGATOR

• Kyle Patrick, DO

  Premier Research Group - Phoenix

  PRINCIPAL INVESTIGATOR

• Antoinette A Pragalos, MD

  Community Research

  PRINCIPAL INVESTIGATOR

• Larry D Reed, MD

  Healthcare Research

  PRINCIPAL INVESTIGATOR

• Eli M Roth, MD

  Sterling Research Group, Ltd

  PRINCIPAL INVESTIGATOR

• Douglas R Schumacher, MD

  Radiant Research, Inc

  PRINCIPAL INVESTIGATOR

• Mark Stich, DO

  Westside Center for Clinical Research

  PRINCIPAL INVESTIGATOR

• Bradley Swenson, MD

  Radiant Research, Inc

  PRINCIPAL INVESTIGATOR

• Gary Tarshis, MD

  Expresscare Clinical Research

  PRINCIPAL INVESTIGATOR

• Haydn M Thomas, MD

  Clinical Trials Technology Inc

  PRINCIPAL INVESTIGATOR

• Cindy Tuten, MD

  Clinical Study Center of Asheville, LLC

  PRINCIPAL INVESTIGATOR

• Larkin T Wadsworth, MD

  Sundance Clinical Research, LLC

  PRINCIPAL INVESTIGATOR

• Robert J Wagner, MD

  Community Research

  PRINCIPAL INVESTIGATOR

• Larry S Watkins, MD

  Lynn Institute of the Ozarks

  PRINCIPAL INVESTIGATOR

• Tamela Zimmerman, MD

  Community Research

  PRINCIPAL INVESTIGATOR

• Marvin Tark, MD

  Drug Studies America

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2012
• First Posted: January 18, 2012
• Study Start: January 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: May 9, 2014
• Results First Posted: May 9, 2014

Record last verified: 2014-04

Locations

US (40)