Status:
COMPLETED
Efficacy and Safety of IV Diclofenac (DIC075V) for Pain After Abdominal or Pelvic Surgery
Lead Sponsor:
Javelin Pharmaceuticals
Conditions:
Pain, Postoperative
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2007
Estimated Enrollment :
331 Patients enrolled
Trial Details
Trial ID
NCT00448110
Start Date
May 1 2006
End Date
November 1 2007
Last Update
May 22 2009
Active Locations (14)
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1
Alabama Clinical Therapeutics
Birmingham, Alabama, United States, 35235
2
Eliza Coffee Memorial Hospital
Florence, Alabama, United States, 35630
3
Drug Research and Analysis Corp.
Montgomery, Alabama, United States, 36106
4
Helen Keller Hospital
Sheffield, Alabama, United States, 35660