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

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00448110
• Other study ID #: DFC-004
• Status: Completed
• Phase: Phase 3
• First received: March 13, 2007
• Last updated: May 21, 2009
• Start date: May 2006
• Est. completion date: November 2007

Study information

• Verified date: May 2009
• Source: Javelin Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 331
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Drug:
• Intravenous Diclofenac (DIC075V)
Intravenous Diclofenac (DIC075V): 1 of 2 dosage levels
• Intravenous Ketorolac
Intravenous Ketorolac
• placebo
placebo

Locations

Country	Name	City	State
United States	Clinical Research Center	Austin	Texas
United States	Alabama Clinical Therapeutics	Birmingham	Alabama
United States	Clinical Research Services	Bismarck	North Dakota
United States	Visions Clinical Research	Boynton Beach	Florida
United States	Duke University Medical Center	Durham	North Carolina
United States	Eliza Coffee Memorial Hospital	Florence	Alabama
United States	Glendale Adventist Medical Center	Glendale	California
United States	Memorial Hermann Healthcare System - Memorial City Hospital	Houston	Texas
United States	Saddleback Memorial Medical Center	Laguna Hills	California
United States	Teton Research / Parkview Surgical	Little Rock	Arkansas
United States	Drug Research and Analysis Corp.	Montgomery	Alabama
United States	Jean Brown Research	Salt Lake City	Utah
United States	Clinical Research Center	San Marcos	Texas
United States	Helen Keller Hospital	Sheffield	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
Javelin Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sum of the pain intensity differences (SPID) over the 0-48 hour time interval.		0-48 hours	No
Secondary	SPID over the 0-24 hour interval		0-24 hours	No
Secondary	Other measures of pain relief		Multiple	No