Trial Outcomes & Findings for Protective Effects of Propylene Glycol in Daily Acetaminophen Dosing (NCT NCT02322879)
NCT ID: NCT02322879
Last Updated: 2017-09-01
Results Overview
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)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
21 participants
Primary outcome timeframe
Daily during the treatment periods (D1-D14 and D29 to 42)
Results posted on
2017-09-01
Participant Flow
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.
Participant milestones
| Measure |
Acetaminophen First, Then Acetaminophen + Propylene Glycol
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.
|
Acetaminophen + Propylene Glycol First, Then Acetaminophen
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.
|
|---|---|---|
|
First Intervention
STARTED
|
11
|
10
|
|
First Intervention
COMPLETED
|
10
|
10
|
|
First Intervention
NOT COMPLETED
|
1
|
0
|
|
Washout
STARTED
|
10
|
10
|
|
Washout
COMPLETED
|
10
|
10
|
|
Washout
NOT COMPLETED
|
0
|
0
|
|
Second Intervention
STARTED
|
10
|
10
|
|
Second Intervention
COMPLETED
|
10
|
10
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Acetaminophen First, Then Acetaminophen + Propylene Glycol
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.
|
Acetaminophen + Propylene Glycol First, Then Acetaminophen
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.
|
|---|---|---|
|
First Intervention
Physician Decision
|
1
|
0
|
Baseline Characteristics
Protective Effects of Propylene Glycol in Daily Acetaminophen Dosing
Baseline characteristics by cohort
| Measure |
Acetaminophen First, Then Acetaminophen + Propylene Glycol
n=10 Participants
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.
|
Acetaminophen + Propylene Glycol First, Then Acetaminophen
n=10 Participants
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
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
28.6 years
n=5 Participants
|
29.8 years
n=7 Participants
|
29.2 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Daily during the treatment periods (D1-D14 and D29 to 42)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)
Outcome measures
| Measure |
Acetaminophen
n=21 Participants
Participants received 4 grams of solid acetaminophen formulation for two weeks
|
Acetaminophen + Propylene Glycol
n=20 Participants
Participants received 4 grams of solid acetaminophen formulation in addition to 70 mg/kg/day of liquid propylene glycol for two weeks
|
|---|---|---|
|
Rise in Plasma Transaminases: Proportion of Responders.
|
6 Participants
|
8 Participants
|
Adverse Events
Acetaminophen
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Acetaminophen + Propylene Glycol
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place