Trial Outcomes & Findings for Puerarin Effects on Alcohol Drinking (NCT NCT00854724)
NCT ID: NCT00854724
Last Updated: 2011-09-09
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
16 participants
Primary outcome timeframe
During a 90 minute drinking session
Results posted on
2011-09-09
Participant Flow
Participant milestones
| Measure |
Placebo, Then Puerarin
|
Puerarin, Then Placebo
|
|---|---|---|
|
First Intervention
STARTED
|
8
|
8
|
|
First Intervention
COMPLETED
|
7
|
7
|
|
First Intervention
NOT COMPLETED
|
1
|
1
|
|
Washout
STARTED
|
7
|
7
|
|
Washout
COMPLETED
|
6
|
6
|
|
Washout
NOT COMPLETED
|
1
|
1
|
|
Second Intervention
STARTED
|
6
|
6
|
|
Second Intervention
COMPLETED
|
5
|
5
|
|
Second Intervention
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Placebo, Then Puerarin
|
Puerarin, Then Placebo
|
|---|---|---|
|
First Intervention
Withdrawal by Subject
|
1
|
1
|
|
Washout
Protocol Violation
|
1
|
0
|
|
Washout
Withdrawal by Subject
|
0
|
1
|
|
Second Intervention
Protocol Violation
|
1
|
0
|
|
Second Intervention
Physician Decision
|
0
|
1
|
Baseline Characteristics
Puerarin Effects on Alcohol Drinking
Baseline characteristics by cohort
| Measure |
Placebo, Then Puerarin
n=8 Participants
|
Puerarin, Then Placebo
n=8 Participants
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
24.3 years
STANDARD_DEVIATION 2.9 • n=5 Participants
|
24.5 years
STANDARD_DEVIATION 3.7 • n=7 Participants
|
24.4 years
STANDARD_DEVIATION 3.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
8 participants
n=7 Participants
|
16 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: During a 90 minute drinking sessionOutcome measures
| Measure |
Placebo, Then Puerarin
n=8 Participants
|
Puerarin, Then Placebo
n=8 Participants
|
|---|---|---|
|
Amount of Alcohol Consumed
|
3.46 Number of drinks consumed
Standard Error 0.55
|
2.36 Number of drinks consumed
Standard Error 0.41
|
Adverse Events
Placebo, Then Puerarin
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Puerarin, Then Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo, Then Puerarin
n=8 participants at risk
|
Puerarin, Then Placebo
n=8 participants at risk
|
|---|---|---|
|
General disorders
headache
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
|
Gastrointestinal disorders
Nausea
|
25.0%
2/8 • Number of events 2
|
12.5%
1/8 • Number of events 1
|
|
Renal and urinary disorders
Urinary Tract infection
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
|
Musculoskeletal and connective tissue disorders
Cheek Pain
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
|
Hepatobiliary disorders
Elevated Liver Enzymes
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place