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

Completed · Phase 3 · Has a placebo group

Conditions studied: Pain, Postoperative

In brief

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

Key facts

Study ID

NCT00448110

Run by

Javelin Pharmaceuticals

People needed

331

Starts

2006-05-01

Expected to finish

2007-11-01

Last updated by the study team

2009-05-22

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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