Study to Assess Effects of Age, Weight, and Body Composition on the Pharmacokinetics of IV Diclofenac Sodium
NCT ID: NCT00509743
Last Updated: 2009-02-12
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
PHASE1
89 participants
INTERVENTIONAL
2007-09-30
2008-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
NONE
Study Groups
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A
Low dose Diclofenac
Intravenous diclofenac sodium (DIC075V)
Low Dose Diclofenac
B
High dose Diclofenac
Intravenous diclofenac sodium (DIC075V)
High dose Diclofenac
Interventions
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Intravenous diclofenac sodium (DIC075V)
High dose Diclofenac
Intravenous diclofenac sodium (DIC075V)
Low Dose Diclofenac
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* History of previous and/or present cerebral hemorrhage, peptic ulceration, GI bleeding or any bleeding diathesis, positive for hepatitis B or hepatitis C or HIV antibodies
18 Years
ALL
Yes
Sponsors
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Javelin Pharmaceuticals
INDUSTRY
Responsible Party
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Javelin Pharmaceuticals
Principal Investigators
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D. Ronald Goldwater, MD
Role: PRINCIPAL_INVESTIGATOR
Parexel
William Gerson, D.O.
Role: PRINCIPAL_INVESTIGATOR
Comprehensive Phase One
Locations
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Comprehensive Phase One
Miramar, Florida, United States
PAREXEL International
Baltimore, Maryland, United States
Countries
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Other Identifiers
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DFC-PK-008
Identifier Type: -
Identifier Source: org_study_id
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