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

Sponsor
Javelin Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT00448110
Collaborator
(none)
331
Enrollment
14
Locations
4
Arms
18
Duration (Months)
23.6
Patients Per Site
1.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Intravenous Diclofenac (DIC075V)
  • Drug: Intravenous Ketorolac
  • Drug: placebo
 Phase 3

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 Design

Study Type:
Interventional
Actual Enrollment :
331 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Study Start Date :
May 1, 2006
Actual Primary Completion Date :
Nov 1, 2007
Actual Study Completion Date :
Nov 1, 2007

Arms and Interventions

Arm Intervention/Treatment
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
Placebo Comparator: D

placebo

Drug: placebo
placebo

Outcome Measures

Primary Outcome Measures

  1. Sum of the pain intensity differences (SPID) over the 0-48 hour time interval. [0-48 hours]

Secondary Outcome Measures

  1. SPID over the 0-24 hour interval [0-24 hours]

  2. Other measures of pain relief [Multiple]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
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
5 Teton Research / Parkview Surgical Little Rock Arkansas United States 72205
6 Glendale Adventist Medical Center Glendale California United States 91206
7 Saddleback Memorial Medical Center Laguna Hills California United States 92653
8 Visions Clinical Research Boynton Beach Florida United States 33437
9 Duke University Medical Center Durham North Carolina United States 27710
10 Clinical Research Services Bismarck North Dakota United States 58501
11 Clinical Research Center Austin Texas United States 78705
12 Memorial Hermann Healthcare System - Memorial City Hospital Houston Texas United States 77024
13 Clinical Research Center San Marcos Texas United States 78666
14 Jean Brown Research Salt Lake City Utah United States 84124

Sponsors and Collaborators

  • Javelin Pharmaceuticals

Investigators

  • Study Director: Javelin Pharmaceuticals, Javelin Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00448110
Other Study ID Numbers:
  • DFC-004
First Posted:
Mar 15, 2007
Last Update Posted:
May 22, 2009
Last Verified:
May 1, 2009
Additional relevant MeSH terms:
Pain, Postoperative
Diclofenac
Ketorolac

Study Results

No Results Posted as of May 22, 2009