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

Phase 3

Completed

• Conditions: Pain, Postoperative
• Interventions: Drug: Intravenous Diclofenac (DIC075V); Drug: Intravenous Ketorolac; Drug: placebo

• Registration Number: NCT00448110
• Lead Sponsor: Javelin Pharmaceuticals

Brief 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.

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 Timeline

• Study Start: 2006-05
• Study First Submitted: 2007-03-13
• Study First Submitted QC: 2007-03-13
• Study First Posted: 2007-03-15
• Primary Completion: 2007-11
• Study Completion: 2007-11
• Status Verified: 2009-05
• Last Update Submitted: 2009-05-21
• Last Update Posted: 2009-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 331

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	Intravenous Diclofenac (DIC075V)	intravenous diclofenac dosage level 2
A	Intravenous Diclofenac (DIC075V)	intravenous diclofenac dosage level 1
C	Intravenous Ketorolac	intravenous ketorolac
D	placebo	placebo

Primary Outcome Measures

Name	Time	Method
Sum of the pain intensity differences (SPID) over the 0-48 hour time interval.	0-48 hours

Secondary Outcome Measures

Name	Time	Method
SPID over the 0-24 hour interval	0-24 hours
Other measures of pain relief	Multiple

Trial Locations

Locations (13)

Teton Research / Parkview Surgical; 🇺🇸 Little Rock, Arkansas, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

Visions Clinical Research; 🇺🇸 Boynton Beach, Florida, United States

Helen Keller Hospital; 🇺🇸 Sheffield, Alabama, United States

Alabama Clinical Therapeutics; 🇺🇸 Birmingham, Alabama, United States

Glendale Adventist Medical Center; 🇺🇸 Glendale, California, United States

Jean Brown Research; 🇺🇸 Salt Lake City, Utah, United States

Clinical Research Center; 🇺🇸 San Marcos, Texas, United States

Saddleback Memorial Medical Center; 🇺🇸 Laguna Hills, California, United States

Drug Research and Analysis Corp.; 🇺🇸 Montgomery, Alabama, United States

Clinical Research Services; 🇺🇸 Bismarck, North Dakota, United States

Eliza Coffee Memorial Hospital; 🇺🇸 Florence, Alabama, United States

Memorial Hermann Healthcare System - Memorial City Hospital; 🇺🇸 Houston, Texas, United States