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

Primary Purpose

Pain, Postoperative

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Intravenous Diclofenac (DIC075V)
Intravenous Ketorolac
placebo
Sponsored by
Javelin Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Alabama Clinical Therapeutics
  • Eliza Coffee Memorial Hospital
  • Drug Research and Analysis Corp.
  • Helen Keller Hospital
  • Teton Research / Parkview Surgical
  • Glendale Adventist Medical Center
  • Saddleback Memorial Medical Center
  • Visions Clinical Research
  • Duke University Medical Center
  • Clinical Research Services
  • Clinical Research Center
  • Memorial Hermann Healthcare System - Memorial City Hospital
  • Clinical Research Center
  • Jean Brown Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Placebo Comparator

Arm Label

A

B

C

D

Arm Description

intravenous diclofenac dosage level 1

intravenous diclofenac dosage level 2

intravenous ketorolac

placebo

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

SPID over the 0-24 hour interval
Other measures of pain relief

Full Information

First Posted
March 13, 2007
Last Updated
May 21, 2009
Sponsor
Javelin Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00448110
Brief Title
Efficacy and Safety of IV Diclofenac (DIC075V) for Pain After Abdominal or Pelvic Surgery
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 Type
Interventional

2. Study Status

Record Verification Date
May 2009
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
November 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Javelin Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
331 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
intravenous diclofenac dosage level 1
Arm Title
B
Arm Type
Experimental
Arm Description
intravenous diclofenac dosage level 2
Arm Title
C
Arm Type
Active Comparator
Arm Description
intravenous ketorolac
Arm Title
D
Arm Type
Placebo Comparator
Arm Description
placebo
Intervention Type
Drug
Intervention Name(s)
Intravenous Diclofenac (DIC075V)
Intervention Description
Intravenous Diclofenac (DIC075V): 1 of 2 dosage levels
Intervention Type
Drug
Intervention Name(s)
Intravenous Ketorolac
Intervention Description
Intravenous Ketorolac
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo
Primary Outcome Measure Information:
Title
Sum of the pain intensity differences (SPID) over the 0-48 hour time interval.
Time Frame
0-48 hours
Secondary Outcome Measure Information:
Title
SPID over the 0-24 hour interval
Time Frame
0-24 hours
Title
Other measures of pain relief
Time Frame
Multiple

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Javelin Pharmaceuticals
Organizational Affiliation
Javelin Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Alabama Clinical Therapeutics
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35235
Country
United States
Facility Name
Eliza Coffee Memorial Hospital
City
Florence
State/Province
Alabama
ZIP/Postal Code
35630
Country
United States
Facility Name
Drug Research and Analysis Corp.
City
Montgomery
State/Province
Alabama
ZIP/Postal Code
36106
Country
United States
Facility Name
Helen Keller Hospital
City
Sheffield
State/Province
Alabama
ZIP/Postal Code
35660
Country
United States
Facility Name
Teton Research / Parkview Surgical
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Glendale Adventist Medical Center
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States
Facility Name
Saddleback Memorial Medical Center
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92653
Country
United States
Facility Name
Visions Clinical Research
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33437
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Clinical Research Services
City
Bismarck
State/Province
North Dakota
ZIP/Postal Code
58501
Country
United States
Facility Name
Clinical Research Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Memorial Hermann Healthcare System - Memorial City Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Facility Name
Clinical Research Center
City
San Marcos
State/Province
Texas
ZIP/Postal Code
78666
Country
United States
Facility Name
Jean Brown Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29492863
Citation
Chelly JE, Lacouture PG, Reyes CRD. Safety of Injectable HPbetaCD-Diclofenac in Older Patients with Acute Moderate-to-Severe Postoperative Pain: A Pooled Analysis of Three Phase III Trials. Drugs Aging. 2018 Mar;35(3):249-259. doi: 10.1007/s40266-018-0529-3.
Results Reference
derived
PubMed Identifier
22886837
Citation
Gan TJ, Daniels SE, Singla N, Hamilton DA, Carr DB. A novel injectable formulation of diclofenac compared with intravenous ketorolac or placebo for acute moderate-to-severe pain after abdominal or pelvic surgery: a multicenter, double-blind, randomized, multiple-dose study. Anesth Analg. 2012 Nov;115(5):1212-20. doi: 10.1213/ANE.0b013e3182691bf9. Epub 2012 Aug 10.
Results Reference
derived

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

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