Efficacy and Safety of IV Diclofenac (DIC075V) for Pain After Abdominal or Pelvic Surgery

Randomized, Double-Blind, Active- and Placebo-Controlled Study of the Efficacy and Safety of Repeated Dosing of DIC075V Relative To Parenteral Ketorolac and Placebo in Patients With Acute Post-Op Pain After Abdominal or Pelvic Surgery

This study will compare repeated intermittent IV dosing of diclofenac in patients with moderate to severe post-surgical pain from abdominal or pelvic surgery.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative
• Intervention / Treatment: Drug: placebo; Drug: Intravenous Diclofenac (DIC075V); Drug: Intravenous Ketorolac

Detailed Description

The primary objective is to evaluate the efficacy and safety of two dosage levels of parenteral diclofenac in providing pain relief as compared to placebo or Ketorolac tromethamine.

• Study Type: Interventional
• Enrollment (Actual): 331
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35235
      • Alabama Clinical Therapeutics
    • Florence, Alabama, United States, 35630
      • Eliza Coffee Memorial Hospital
    • Montgomery, Alabama, United States, 36106
      • Drug Research and Analysis Corp.
    • Sheffield, Alabama, United States, 35660
      • Helen Keller Hospital
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Teton Research / Parkview Surgical
  • California
    • Glendale, California, United States, 91206
      • Glendale Adventist Medical Center
    • Laguna Hills, California, United States, 92653
      • Saddleback Memorial Medical Center
  • Florida
    • Boynton Beach, Florida, United States, 33437
      • Visions Clinical Research
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
  • North Dakota
    • Bismarck, North Dakota, United States, 58501
      • Clinical Research Services
  • Texas
    • Austin, Texas, United States, 78705
      • Clinical Research Center
    • Houston, Texas, United States, 77024
      • Memorial Hermann Healthcare System - Memorial City Hospital
    • San Marcos, Texas, United States, 78666
      • Clinical Research Center
  • Utah
    • Salt Lake City, Utah, United States, 84124
      • Jean Brown Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Scheduled within two weeks of the screening visit to undergo abdominal or pelvic surgery
• Moderate to severe pain within 6 hours following completion of the required surgery.

Exclusion Criteria:

• Surgical procedure involves a subcostal incision.
• Chronic disease or recent cardiovascular events.
• Known allergy or hypersensitivity to the active compounds or any of the excipients used in the study.

Additional Inclusion/Exclusion Criteria May Apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: D; placebo	Drug: placebo; placebo
Experimental: A; intravenous diclofenac dosage level 1	Drug: Intravenous Diclofenac (DIC075V); Intravenous Diclofenac (DIC075V): 1 of 2 dosage levels
Experimental: B; intravenous diclofenac dosage level 2	Drug: Intravenous Diclofenac (DIC075V); Intravenous Diclofenac (DIC075V): 1 of 2 dosage levels
Active Comparator: C; intravenous ketorolac	Drug: Intravenous Ketorolac; Intravenous Ketorolac

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Sum of the pain intensity differences (SPID) over the 0-48 hour time interval.	0-48 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
SPID over the 0-24 hour interval	0-24 hours
Other measures of pain relief	Multiple

Collaborators and Investigators

• Sponsor: Javelin Pharmaceuticals
• Investigators: Study Director: Javelin Pharmaceuticals, Javelin Pharmaceuticals

Publications and helpful links

General Publications

• Chelly JE, Lacouture PG, Reyes CRD. Safety of Injectable HPbetaCD-Diclofenac in Older Patients with Acute Moderate-to-Severe Postoperative Pain: A Pooled Analysis of Three Phase III Trials. Drugs Aging. 2018 Mar;35(3):249-259. doi: 10.1007/s40266-018-0529-3.
• Gan TJ, Daniels SE, Singla N, Hamilton DA, Carr DB. A novel injectable formulation of diclofenac compared with intravenous ketorolac or placebo for acute moderate-to-severe pain after abdominal or pelvic surgery: a multicenter, double-blind, randomized, multiple-dose study. Anesth Analg. 2012 Nov;115(5):1212-20. doi: 10.1213/ANE.0b013e3182691bf9. Epub 2012 Aug 10.

Study record dates

Study Major Dates

• Study Start: May 1, 2006
• Primary Completion (Actual): November 1, 2007
• Study Completion (Actual): November 1, 2007

Study Registration Dates

• First Submitted: March 13, 2007
• First Submitted That Met QC Criteria: March 13, 2007
• First Posted (Estimate): March 15, 2007

Study Record Updates

• Last Update Posted (Estimate): May 22, 2009
• Last Update Submitted That Met QC Criteria: May 21, 2009
• Last Verified: May 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Ketorolac; Diclofenac
• Other Study ID Numbers: DFC-004