Aminotransferase Trends During Prolonged Acetaminophen Dosing
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|ClinicalTrials.gov Identifier: NCT00743093|
Recruitment Status : Completed
First Posted : August 28, 2008
Results First Posted : July 25, 2013
Last Update Posted : September 18, 2013
Denver Health and Hospital Authority
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Information provided by (Responsible Party):
Kennon Heard, Denver Health and Hospital Authority
|Study Design||Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Recruitment Details||Recruitment took place from August 2008 through August 2011 in the Denver Metro area. Healthy volunteers were recruited from the community through the use of approved advertisements.|
|Pre-assignment Details||398 subjects were consented for the study. Of these, 122 were excluded for not meeting full eligibility criteria. 276 eligible subjects were assigned to treatment groups, of which 252 completed all study requirements.|
This study was limited to healthy volunteers. The ingestion of each dose of study drug and use of other medications was self-reported.