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Sponsored by: |
Cadence Pharmaceuticals |
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Information provided by: | Cadence Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00564629 |
To assess the rapidity of onset of antipyretic effect and the efficacy and safety of a single dose of IV APAP versus PO acetaminophen in the treatment of fever induced by a standard dose of endotoxin
Condition | Intervention | Phase |
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Fever |
Drug: IV APAP Drug: Oral acetaminophen |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase III, Randomized, Double-Blind, Double-Dummy, Single-Dose Study of the Efficacy and Safety of Intravenous Acetaminophen Versus Oral Acetaminophen for the Treatment of Endotoxin-Induced Fever in Healthy Adult Males |
Enrollment: | 81 |
Study Start Date: | July 2007 |
Study Completion Date: | October 2007 |
Primary Completion Date: | October 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
IV acetaminophen plus oral placebo.
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Drug: IV APAP
Single dose of 1gm IV
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2: Active Comparator
Oral acetaminophen plus IV placebo.
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Drug: Oral acetaminophen
Acetaminophen single-dose 1 gm PO
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To assess the rapidity of onset of antipyretic effect and the efficacy and safety of a single dose of IV APAP versus PO acetaminophen in the treatment of fever induced by a standard dose of endotoxin
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria (Screening) To be eligible for entry into the Study, Subjects must meet all of the following criteria at Screening:
Inclusion Criteria (Pre-Randomization) To be eligible for Randomization, Subjects must meet each of the following criteria:
Exclusion Criteria:
United States, Tennessee | |
New Orleans Center for Clinical Research-Knoxville | |
Knoxville, Tennessee, United States, 37920 |
Study Director: | Mike Royal, MD, JD, MBA | Cadence Pharmaceuticals |
Responsible Party: | Cadence Pharmaceuticals ( Mike Royal MD JD MBA, VP Clinical Development, Analgesics ) |
Study ID Numbers: | CPI-APF-303 |
Study First Received: | November 26, 2007 |
Last Updated: | January 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00564629 |
Health Authority: | United States: Food and Drug Administration |
Fever Signs and Symptoms Healthy Acetaminophen |
Sensory System Agents Analgesics, Non-Narcotic Therapeutic Uses Physiological Effects of Drugs Peripheral Nervous System Agents |
Analgesics Body Temperature Changes Central Nervous System Agents Pharmacologic Actions |