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Sponsors and Collaborators: |
Denver Health and Hospital Authority McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc. |
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Information provided by: | Denver Health and Hospital Authority |
ClinicalTrials.gov Identifier: | NCT00743093 |
The objective of this study is to monitor liver function tests (blood levels of an indicator of liver function) of healthy people taking the maximum labeled daily dose of acetaminophen compared to people taking placebo for 16 to 40 days. Those people that continue to have normal liver tests after 16 days will have completed their part of the study. People that develop abnormal liver function tests will continue taking acetaminophen or placebo, and have their liver tests monitored closely for up to an additional 24 days. This is to (1) make sure these tests return to normal and (2) determine when these tests return to normal while still taking acetaminophen or placebo. If at any time the liver tests indicate anything more than a minor increase, you would be immediately told to stop taking the study drug.
Condition | Intervention | Phase |
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Drug Toxicity Healthy |
Drug: acetaminophen Drug: placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety Study |
Official Title: | Aminotransferase Trends During Prolonged Therapeutic Acetaminophen Dosing |
Estimated Enrollment: | 426 |
Study Start Date: | August 2008 |
Estimated Study Completion Date: | August 2009 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
acetaminophen
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Drug: acetaminophen
500 mg caplets; 2 capsules (1 g)/dose; 4 doses (4 g)/day, 4 hours apart for 16 to 40 days.
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2: Placebo Comparator
placebo
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Drug: placebo
placebo caplets, 2 caplets per dose, 4 doses per day, 4 hours apart for 16 to 40 days
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Acetaminophen use is common and many consumers take 4g/day for longer than 4 days. The use of 4g/day of acetaminophen for more than 4 days causes an asymptomatic ALT elevation in some people. This elevation most likely resolves while continuing treatment, but it is possible that some individuals may go on to develop clinical liver injury. By carefully following healthy subjects who are taking the maximal daily dose of acetaminophen, we can safely determine if the ALT elevation resolves or progresses to clinical liver injury. If a subject develops clinical liver injury we can intervene before irreversible injury occurs.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jody L Green, PhD | 303-739-1246 | jody.green@rmpdc.org |
United States, Colorado | |
Denver Health Rocky Mountain Poison and Drug Center | Recruiting |
Denver, Colorado, United States, 80204 | |
Contact: Jody L Green, PhD 303-739-1246 jody.green@rmpdc.org | |
Principal Investigator: Kennon Heard, MD | |
University of Colorado Health Sciences Center - GCRC | Not yet recruiting |
Aurora, Colorado, United States, 80045 | |
Contact: Jody L Green, PhD 303-739-1246 jody.green@rmpdc.org | |
Principal Investigator: Kennon Heard, MD |
Principal Investigator: | Kennon Heard, MD | Denver Health/Rocky Mountain Poison & Drug Center |
Responsible Party: | Denver Health and Hospital Authority ( Kennon Heard, MD/Fellowship Director ) |
Study ID Numbers: | COMIRB #06-1265 |
Study First Received: | August 26, 2008 |
Last Updated: | August 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00743093 |
Health Authority: | United States: Food and Drug Administration |
acetaminophen protein adducts drug safety alanine aminotransferase Alanine Amino Transferase |
Drug Toxicity Poisoning Disorders of Environmental Origin Healthy Acetaminophen |
Sensory System Agents Analgesics, Non-Narcotic Therapeutic Uses Physiological Effects of Drugs |
Peripheral Nervous System Agents Analgesics Central Nervous System Agents Pharmacologic Actions |