Study of Diclofenac Capsules to Treat Osteoarthritis Pain

NCT01461369 | Completed Phase 3 Results

• 1 other identifier: DIC3-08-05
• Study Type: interventional
• Target: 305
• Locations: 1 country
• Sites: 40

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.

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• 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.

  The pain in subjects with osteoarthritis was measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score. The WOMAC pain subscale score is calculated as the average of the visual analogue scale (VAS) scores from 5 pain subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their pain level over the last 24 hours, with 0 mm representing "No Pain" and 100 mm representing "Extreme Pain". The WOMAC pain subscale score difference is calculated as the WOMAC pain subscale score assessed at Week 12 minus the WOMAC pain subscale score assessed at baseline.

  Baseline to Week 12/Early Termination

Secondary Outcomes (5)

• 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.

  Baseline to Week 2

• 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.

  Baseline to Week 6

• 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.

  Baseline to Week 12/Early Termination

• 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.

  Baseline to Week 12/Early Termination

• 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.

  Baseline to Week 12/Early Termination

Study Arms (3)

Diclofenac Capsules 35 mg bid

EXPERIMENTAL

Drug: Diclofenac

Diclofenac Capsules 35 mg tid

EXPERIMENTAL

Drug: Diclofenac

Placebo Capsule

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Diclofenac DRUG

35 mg bid Capsules

Diclofenac Capsules 35 mg bid

Placebo DRUG

Capsules

Placebo Capsule

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

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)

• 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.

  PMID: 25050589 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 Research, Corporation

  PRINCIPAL INVESTIGATOR

• Matthew Barton, MD

  Office of Matthew Barton, MD

  PRINCIPAL INVESTIGATOR

• David Bouda, MD

  Heartland Clinical Research, Inc

  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, PhD

  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

• Marvin Tark, MD

  Drug Studies America

  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

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2011
• First Posted: October 28, 2011
• Study Start: October 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: October 1, 2012
• Last Updated: May 26, 2014
• Results First Posted: May 26, 2014

Record last verified: 2014-04

Locations

US (40)