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Protective Effects of Propylene Glycol in Daily Acetaminophen Dosing (APAPII)

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ClinicalTrials.gov Identifier: NCT02322879
Recruitment Status : Completed
First Posted : December 23, 2014
Results First Posted : September 1, 2017
Last Update Posted : September 1, 2017
Sponsor:
Collaborator:
Harvard University
Information provided by (Responsible Party):
Michael Ganetsky, Beth Israel Deaconess Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Acetaminophen Toxicity
Interventions Drug: First Treatment Period
Other: Washout
Drug: Second Treatment Period
Enrollment 21
Recruitment Details After responding to the internet or print advertisement, prospective subjects were scheduled for a screening visit at the Harvard Catalyst Clinical Research Center (CRC) at BIDMC between May 2013 and August 2016. In all participants, consent was obtained prior to initiating any screening evaluation.
Pre-assignment Details  
Arm/Group Title Acetaminophen First, Then Acetaminophen + Propylene Glycol Acetaminophen + Propylene Glycol First, Then Acetaminophen
Hide Arm/Group Description

Participants in this arm received 4 grams of solid acetaminophen formulation for two weeks, followed by a two week wash out period.

Then, subjects received 4 grams of solid acetaminophen formulation in addition to 70 mg/kg/day of liquid propylene glycol for two weeks.

Participants in this arm received 4 grams of solid acetaminophen formulation in addition to 70 mg/kg/day of liquid propylene glycol for two weeks, followed by a two week wash out period.

Then, subjects received 4 grams of solid acetaminophen formulation for two weeks.
Period Title: First Intervention
Started 11 10
Completed 10 10
Not Completed 1 0
Reason Not Completed
Physician Decision             1             0
Period Title: Washout
Started 10 10
Completed 10 10
Not Completed 0 0
Period Title: Second Intervention
Started 10 10
Completed 10 10
Not Completed 0 0
Arm/Group Title Acetaminophen First, Then Acetaminophen + Propylene Glycol Acetaminophen + Propylene Glycol First, Then Acetaminophen Total
Hide Arm/Group Description

Participants in this arm received 4 grams of solid acetaminophen formulation for two weeks, followed by a two week wash out period.

Then, subjects received 4 grams of solid acetaminophen formulation in addition to 70 mg/kg/day of liquid propylene glycol for two weeks.

Participants in this arm received 4 grams of solid acetaminophen formulation in addition to 70 mg/kg/day of liquid propylene glycol for two weeks, followed by a two week wash out period.

Then, subjects received 4 grams of solid acetaminophen formulation for two weeks.

 Total of all reporting groups
Overall Number of Baseline Participants 10 10 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 10 participants 10 participants 20 participants
28.6
(21 to 37)
29.8
(24 to 37)
29.2
(21 to 37)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
Female
6
  60.0%
8
  80.0%
14
  70.0%
Male
4
  40.0%
2
  20.0%
6
  30.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
Hispanic or Latino
1
  10.0%
1
  10.0%
2
  10.0%
Not Hispanic or Latino
9
  90.0%
9
  90.0%
18
  90.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
  10.0%
1
   5.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
3
  30.0%
1
  10.0%
4
  20.0%
White
6
  60.0%
7
  70.0%
13
  65.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
  10.0%
1
  10.0%
2
  10.0%
1.Primary Outcome
Title Rise in Plasma Transaminases: Proportion of Responders.
Hide Description Blood tests to monitor Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) were obtained on every visit prior dosing. ALT and AST were analyzed on a Roche Cobas c501 chemistry module at BIDMC. Responders was defined as peak ALT increased 2x baseline (average of first 3 days)
Time Frame Daily during the treatment periods (D1-D14 and D29 to 42)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Acetaminophen Acetaminophen + Propylene Glycol
Hide Arm/Group Description:
Participants received 4 grams of solid acetaminophen formulation for two weeks
Participants received 4 grams of solid acetaminophen formulation in addition to 70 mg/kg/day of liquid propylene glycol for two weeks
Overall Number of Participants Analyzed 21 20
Measure Type: Count of Participants
Unit of Measure: Participants
6
  28.6%
8
  40.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Acetaminophen, Acetaminophen + Propylene Glycol
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.59
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Time Frame During Participation in the study (6 weeks)
Adverse Event Reporting Description Adverse events were be monitored at every by trained investigators at the Harvard-Thorndike Clinical Research Center at Beth Israel Deaconess Medical Center. Additionally, study participants were instructed to contact the study team for any symptoms out of the ordinary.
 
Arm/Group Title Acetaminophen Acetaminophen + Propylene Glycol
Hide Arm/Group Description Participants received 4 grams of solid acetaminophen formulation for two weeks. Participants received 4 grams of solid acetaminophen formulation in addition to 70 mg/kg/day of liquid propylene glycol for two weeks.
All-Cause Mortality
Acetaminophen Acetaminophen + Propylene Glycol
Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)   0/20 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Acetaminophen Acetaminophen + Propylene Glycol
Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)   0/20 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Acetaminophen Acetaminophen + Propylene Glycol
Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)   0/20 (0.00%) 
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Michael Ganetsky, MD
Organization: BIDMC
Phone: 617-754-2323
EMail: mganetsk@bidmc.harvard.edu
Layout table for additonal information
Responsible Party: Michael Ganetsky, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT02322879     History of Changes
Other Study ID Numbers: 2013P000070
First Submitted: October 22, 2014
First Posted: December 23, 2014
Results First Submitted: March 29, 2017
Results First Posted: September 1, 2017
Last Update Posted: September 1, 2017