Efficacy and Safety of IV Diclofenac (DIV075V)for Pain After Elective Orthopedic Surgery
NCT ID: NCT00507026
Last Updated: 2021-10-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
277 participants
INTERVENTIONAL
2007-07-25
2008-10-14
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
DIC075V (IV diclofenac)
IV Diclofenac
IV Diclofenac q6h
B
IV Ketorolac
IV ketorolac
IV ketorolac q6h
C
Placebo
Placebo
Placebo q6h
Interventions
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IV Diclofenac
IV Diclofenac q6h
IV ketorolac
IV ketorolac q6h
Placebo
Placebo q6h
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
85 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Helen Keller Hospital
Sheffield, Alabama, United States
Arizona Research Center
Phoenix, Arizona, United States
Accurate Clinical Trials
San Clemente, California, United States
East Coast Clincial Research
Ft. Pierce, Florida, United States
Outcomes Research Institute
Louisville, Kentucky, United States
American Institute of Healthcare and Fitness
Raleigh, North Carolina, United States
University Orthopedics Center
State College, Pennsylvania, United States
SCIREX
Austin, Texas, 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.
Other Identifiers
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C1211009
Identifier Type: OTHER
Identifier Source: secondary_id
DFC-005
Identifier Type: -
Identifier Source: org_study_id