Acetaminophen Adduct Formation in Non-Drinkers Taking Therapeutic Doses of Acetaminophen for Ten Consecutive Days (Non-Drinker)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00616018|
Recruitment Status : Completed
First Posted : February 14, 2008
Results First Posted : July 12, 2012
Last Update Posted : July 12, 2012
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: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label)|
Drug Induced Liver Injury
|Recruitment Details||Study was conducted from August 2007 through January 2008. Healthy volunteers were recruited through flyers posted in community settings.|
|Pre-assignment Details||Thirty-five subjects were consented for the study. Of these, eight were excluded (six did not meet inclusion criteria and two refused to participate). The 27 eligible subjects were assigned to the treatment arm to receive 4 grams of acetaminophen per day, for 10 consecutive days.|
One limitation is that this study did not include a placebo group. The study was limited to healthy volunteers. The ingestion of each dose and use of other medications was self-reported.