Efficacy and Safety of IV Diclofenac (DIC075V) for Pain After Abdominal or Pelvic Surgery
NCT ID: NCT00448110
Last Updated: 2009-05-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
331 participants
INTERVENTIONAL
2006-05-31
2007-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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A
intravenous diclofenac dosage level 1
Intravenous Diclofenac (DIC075V)
Intravenous Diclofenac (DIC075V): 1 of 2 dosage levels
B
intravenous diclofenac dosage level 2
Intravenous Diclofenac (DIC075V)
Intravenous Diclofenac (DIC075V): 1 of 2 dosage levels
C
intravenous ketorolac
Intravenous Ketorolac
Intravenous Ketorolac
D
placebo
placebo
placebo
Interventions
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Intravenous Diclofenac (DIC075V)
Intravenous Diclofenac (DIC075V): 1 of 2 dosage levels
Intravenous Ketorolac
Intravenous Ketorolac
placebo
placebo
Eligibility Criteria
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Inclusion Criteria
* Moderate to severe pain within 6 hours following completion of the required surgery.
Exclusion Criteria
* Chronic disease or recent cardiovascular events.
* Known allergy or hypersensitivity to the active compounds or any of the excipients used in the study.
18 Years
65 Years
ALL
No
Sponsors
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Javelin Pharmaceuticals
INDUSTRY
Responsible Party
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Javelin Pharmaceuticals
Principal Investigators
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Javelin Pharmaceuticals
Role: STUDY_DIRECTOR
Javelin Pharmaceuticals
Locations
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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
Countries
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References
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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.
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.
Other Identifiers
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DFC-004
Identifier Type: -
Identifier Source: org_study_id
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