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Study of Diclofenac Capsules to Treat Pain Following Bunionectomy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Iroko Pharmaceuticals, LLC
ClinicalTrials.gov Identifier:
NCT01462435
First received: October 26, 2011
Last updated: January 7, 2013
Last verified: February 2012
History of Changes
  Purpose

The purpose of this study is to determine whether Diclofenac [Test] Capsules are safe and effective for the treatment of bunionectomy pain.


Condition Intervention Phase
Other Acute Postoperative Pain
 Drug: Diclofenac Test (lower dose)
Drug: Diclofenac Test (upper dose)
Drug: Celecoxib
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-Blind, Multiple-Dose, Parallel-Group, Active- and Placebo-Controlled Study of Diclofenac [Test] Capsules for the Treatment of Acute Postoperative Pain After Bunionectomy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Iroko Pharmaceuticals, LLC:

Primary Outcome Measures:
  • VAS summed pain intensity difference (VAS SPID) over 0 to 48 hours (VAS SPID-48) after Time 0 [ Time Frame: 0 - 48 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • VAS pain intensity difference (VAS PID) at each scheduled time point up to 48 hours [ Time Frame: 0 - 48 hours ] [ Designated as safety issue: No ]
  • VAS pain intensity score at each scheduled time point [ Time Frame: 0 - 48 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 424
Study Start Date: October 2011
Study Completion Date: August 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Diclofenac Test (lower dose) Drug: Diclofenac Test (lower dose)
Capsules
Experimental: Diclofenac Test (upper dose) Drug: Diclofenac Test (upper dose)
Capsules
Active Comparator: Celecoxib Drug: Celecoxib
2 X 200 mg
Placebo Comparator: Placebo Drug: Placebo
Capsules

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient is male or female between 18 and 65 years of age
  • 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
  • Has undergone primary, unilateral, first metatarsal bunionectomy with no additional collateral procedures
  • Patient must be willing to stay at the study site ≥ 72 hours

Exclusion Criteria:

  • Patient has hypersensitivity, allergy, or clinically significant intolerance to any medications to be used in the study, or related drugs
  • Patient has a current disease or history of a disease that will impact the study or the patient's well-being
  • Patient has used or intends to use any of the medications that are prohibited by the protocol
  • Patient has a history of drug or alcohol abuse or dependence, or patient has a positive urine drug screen or alcohol breathalyzer test
  • Patient has taken another investigational drug within 30 days prior to screening
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01462435

Locations
United States, Arizona
Premier Research Group Limited
Phoenix, Arizona, United States, 85027
United States, Maryland
Chesapeake Research Group, LLC
Pasadena, Maryland, United States, 21122
United States, Texas
Premier Research Group Limited
Austin, Texas, United States, 78705
United States, Utah
Premier Research Group Limited
Salt Lake City, Utah, United States, 84107
Sponsors and Collaborators
Iroko Pharmaceuticals, LLC
Investigators
Principal Investigator: Michael Golf, DPM Premier Research Group Limited
Principal Investigator: Ira Gottlieb, DPM Chesapeake Research Group, LLC
Principal Investigator: Kyle Patrick, DO Premier Research Group Limited
Principal Investigator: S. Thomas Schiffgen, DPM Premier Research Group Limited
  More Information

No publications provided

Responsible Party: Iroko Pharmaceuticals, LLC
ClinicalTrials.gov Identifier: NCT01462435     History of Changes
Other Study ID Numbers: DIC3-08-04
Study First Received: October 26, 2011
Last Updated: January 7, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Diclofenac
Celecoxib
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents
Cyclooxygenase 2 Inhibitors

ClinicalTrials.gov processed this record on May 23, 2013