Trial Outcomes & Findings for Ability of Partial Inverse Agonist, Iomazenil, to Block Ethanol Effects in Humans (NCT NCT01590277)
NCT ID: NCT01590277
Last Updated: 2024-10-09
Results Overview
A 14-item scale with 7 items designated to assess stimulant effects associated with the ascending limb of ethanol intoxication and 7 items developed to measure sedative effects associated with the descending limb of ethanol intoxication. The BAES full scale would be 0 to 140. However, the scale itself is analyzed by breaking up the full 14 item scale into 2 parts - sedation and stimulation. Therefore, the total score for sedation ranges from 0 to 70, with higher scores indicating more sedation, and the total score for stimulation also ranges from 0 to 70, with higher scores indicating more stimulation. Timepoints: Administered 160 mins (M160) and 10 mins (M10) prior to the target ethanol/placebo dose being reached, when the target ethanol dose (BrAC of 0.1%)/placebo has been reached (0), and 15 (P15), 70 (P70), 90 (P90), and 150 (P150) minutes after the target ethanol/placebo dose has been reached.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
33 participants
Primary outcome timeframe
Administered 160 mins and 10 mins prior to the target ethanol/placebo dose being reached, when the target ethanol dose (BrAC of 0.1%)/placebo has been reached, and 15, 70, 90, 150, and 240 minutes after the target ethanol/placebo dose has been reached.
Results posted on
2024-10-09
Participant Flow
33 participants initiated study procedures beyond screening. Of these 33 participants, 30 completed all four test days (thus receiving all four treatment conditions, one on each of the four test days), 2 participants withdrew from the study after 2 test days (receiving 2 out of the 4 treatment conditions), and 1 participant withdrew after 1 test day (receiving 1 out of the 4 treatment conditions..
Each participant will receive in a randomized, double-blind, cross-over design, ethanol or placebo and iomazenil or placebo. Potential randomizations for each test day: a) active ethanol and placebo iomazenil, b) active ethanol and active iomazenil, c) placebo ethanol and active iomazenil, and d) placebo ethanol and placebo iomazenil
Participant milestones
| Measure |
All Study Participants
ARM 1: Active Ethanol and Active Iomazenil:
Active Ethanol: Target BrAC of 0.1% reached over 30 minutes and then clamped to maintain this dose for an additional 60 minutes. This dose is equivalent to consuming approximately 5 drinks. Administered over a total of 90 minutes.
Active Iomazenil: Active iomazenil, administered intravenously at a dose of 3.7 ug/kg. Administered over 10 minutes, beginning 10 minutes after the start of the ethanol/placebo clamp.
ARM 2: Active Ethanol and Placebo Iomazenil
Active Ethanol: Target BrAC of 0.1% reached over 30 minutes and then clamped to maintain this dose for an additional 60 minutes. This dose is equivalent to consuming approximately 5 drinks. Administered over a total of 90 minutes.
Placebo: Control: no iomazenil, administered for a total of 10 minutes
ARM 3: Placebo Ethanol and Active Iomazenil.
Active Iomazenil: Active iomazenil, administered intravenously at a dose of 3.7 ug/kg. Administered over 10 minutes, beginning 10 minutes after the start of the ethanol/placebo clamp.
Placebo: Control: no alcohol, administered for a total of 90 minutes.
ARM 4: Placebo Ethanol and Placebo Iomazenil
Placebo: Control: no alcohol, administered for a total of 90 minutes.
Placebo: Control: no iomazenil, administered for a total of 10 minutes
|
|---|---|
|
Overall Study
STARTED
|
33
|
|
Overall Study
Active Ethanol and Placebo Iomazenil
|
31
|
|
Overall Study
Active Ethanol and Active Iomazenil
|
30
|
|
Overall Study
Placebo Ethanol and Active Iomazenil
|
32
|
|
Overall Study
Placebo Ethanol and Placebo Iomazenil
|
32
|
|
Overall Study
COMPLETED
|
26
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
All Study Participants
ARM 1: Active Ethanol and Active Iomazenil:
Active Ethanol: Target BrAC of 0.1% reached over 30 minutes and then clamped to maintain this dose for an additional 60 minutes. This dose is equivalent to consuming approximately 5 drinks. Administered over a total of 90 minutes.
Active Iomazenil: Active iomazenil, administered intravenously at a dose of 3.7 ug/kg. Administered over 10 minutes, beginning 10 minutes after the start of the ethanol/placebo clamp.
ARM 2: Active Ethanol and Placebo Iomazenil
Active Ethanol: Target BrAC of 0.1% reached over 30 minutes and then clamped to maintain this dose for an additional 60 minutes. This dose is equivalent to consuming approximately 5 drinks. Administered over a total of 90 minutes.
Placebo: Control: no iomazenil, administered for a total of 10 minutes
ARM 3: Placebo Ethanol and Active Iomazenil.
Active Iomazenil: Active iomazenil, administered intravenously at a dose of 3.7 ug/kg. Administered over 10 minutes, beginning 10 minutes after the start of the ethanol/placebo clamp.
Placebo: Control: no alcohol, administered for a total of 90 minutes.
ARM 4: Placebo Ethanol and Placebo Iomazenil
Placebo: Control: no alcohol, administered for a total of 90 minutes.
Placebo: Control: no iomazenil, administered for a total of 10 minutes
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Ability of Partial Inverse Agonist, Iomazenil, to Block Ethanol Effects in Humans
Baseline characteristics by cohort
| Measure |
Enrolled Participants (N=33)
n=33 Participants
Baseline demographics for all participants that initiated study procedures beyond screening.
Participants will receive in a randomized, double-blind, cross-over design, ethanol or placebo and iomazenil or placebo on each of 4 separate test days. Potential Randomizations for each test day are: a) active ethanol and placebo iomazenil, b) active ethanol and active iomazenil, c) placebo ethanol and active iomazenil, and d) placebo ethanol and placebo iomazenil. A participant who completes all four test days will receive each of the potential randomizations throughout their study participation.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
33 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
25.76 years
STANDARD_DEVIATION 3.55 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
28 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Administered 160 mins and 10 mins prior to the target ethanol/placebo dose being reached, when the target ethanol dose (BrAC of 0.1%)/placebo has been reached, and 15, 70, 90, 150, and 240 minutes after the target ethanol/placebo dose has been reached.A 14-item scale with 7 items designated to assess stimulant effects associated with the ascending limb of ethanol intoxication and 7 items developed to measure sedative effects associated with the descending limb of ethanol intoxication. The BAES full scale would be 0 to 140. However, the scale itself is analyzed by breaking up the full 14 item scale into 2 parts - sedation and stimulation. Therefore, the total score for sedation ranges from 0 to 70, with higher scores indicating more sedation, and the total score for stimulation also ranges from 0 to 70, with higher scores indicating more stimulation. Timepoints: Administered 160 mins (M160) and 10 mins (M10) prior to the target ethanol/placebo dose being reached, when the target ethanol dose (BrAC of 0.1%)/placebo has been reached (0), and 15 (P15), 70 (P70), 90 (P90), and 150 (P150) minutes after the target ethanol/placebo dose has been reached.
Outcome measures
| Measure |
Active Ethanol and Active Iomazenil
n=30 Participants
Each participant will receive in a randomized, double-blind, cross-over design, ethanol or placebo and iomazenil or placebo.
Potential randomizations for each test day: a) active ethanol and placebo iomazenil, b) active ethanol and active iomazenil, c) placebo ethanol and active iomazenil, and d) placebo ethanol and placebo iomazenil
Active Ethanol: Target BrAC of 0.1% reached over 30 minutes and then clamped to maintain this dose for an additional 60 minutes. This dose is equivalent to consuming approximately 5 drinks. Administered over a total of 90 minutes.
Active Iomazenil: Active iomazenil, administered intravenously at a dose of 3.7 ug/kg. Administered over 10 minutes, beginning 10 minutes after the start of the ethanol/placebo clamp.
|
Active Ethanol and Placebo Iomazenil
n=31 Participants
Each participant will receive in a randomized, double-blind, cross-over design, ethanol or placebo and iomazenil or placebo.
Potential randomizations for each test day: a) active ethanol and placebo iomazenil, b) active ethanol and active iomazenil, c) placebo ethanol and active iomazenil, and d) placebo ethanol and placebo iomazenil
Active Ethanol: Target BrAC of 0.1% reached over 30 minutes and then clamped to maintain this dose for an additional 60 minutes. This dose is equivalent to consuming approximately 5 drinks. Administered over a total of 90 minutes.
Placebo: Control: no iomazenil, administered for a total of 10 minutes
|
Placebo Ethanol and Active Iomazenil
n=32 Participants
Each participant will receive in a randomized, double-blind, cross-over design, ethanol or placebo and iomazenil or placebo.
Potential randomizations for each test day: a) active ethanol and placebo iomazenil, b) active ethanol and active iomazenil, c) placebo ethanol and active iomazenil, and d) placebo ethanol and placebo iomazenil
Active Iomazenil: Active iomazenil, administered intravenously at a dose of 3.7 ug/kg. Administered over 10 minutes, beginning 10 minutes after the start of the ethanol/placebo clamp.
Placebo: Control: no alcohol, administered for a total of 90 minutes.
|
Placebo Ethanol and Placebo Iomazenil
n=32 Participants
Each participant will receive in a randomized, double-blind, cross-over design, ethanol or placebo and iomazenil or placebo.
Potential randomizations for each test day: a) active ethanol and placebo iomazenil, b) active ethanol and active iomazenil, c) placebo ethanol and active iomazenil, and d) placebo ethanol and placebo iomazenil
Placebo: Control: no alcohol, administered for a total of 90 minutes.
Placebo: Control: no iomazenil, administered for a total of 10 minutes
|
|---|---|---|---|---|
|
Biphasic Ethanol Effects Scale (BAES)
Sedation Effects (Timepoint M160)
|
3.767 score on a scale
Standard Deviation 6.826
|
3.935 score on a scale
Standard Deviation 7.771
|
3.813 score on a scale
Standard Deviation 7.368
|
3.194 score on a scale
Standard Deviation 5.431
|
|
Biphasic Ethanol Effects Scale (BAES)
Sedation Effects (Timepoint M10)
|
4.767 score on a scale
Standard Deviation 5.74
|
4.484 score on a scale
Standard Deviation 6.623
|
3.438 score on a scale
Standard Deviation 5.853
|
3.968 score on a scale
Standard Deviation 7.092
|
|
Biphasic Ethanol Effects Scale (BAES)
Sedation Effects (Timepoint 0)
|
5.267 score on a scale
Standard Deviation 5.271
|
5.258 score on a scale
Standard Deviation 6.153
|
2.875 score on a scale
Standard Deviation 5.74
|
3.452 score on a scale
Standard Deviation 6.35
|
|
Biphasic Ethanol Effects Scale (BAES)
Sedation Effects (Timepoint P15)
|
7 score on a scale
Standard Deviation 7.409
|
5.677 score on a scale
Standard Deviation 7.368
|
6.75 score on a scale
Standard Deviation 8.74
|
3.387 score on a scale
Standard Deviation 6.249
|
|
Biphasic Ethanol Effects Scale (BAES)
Sedation Effects (Timepoint P70)
|
7.2 score on a scale
Standard Deviation 11.075
|
6.806 score on a scale
Standard Deviation 9.393
|
3.469 score on a scale
Standard Deviation 6.17
|
2.516 score on a scale
Standard Deviation 5.092
|
|
Biphasic Ethanol Effects Scale (BAES)
Sedation Effects (Timepoint P90)
|
4.9 score on a scale
Standard Deviation 6.088
|
5.677 score on a scale
Standard Deviation 8.89
|
2.875 score on a scale
Standard Deviation 6.384
|
1.452 score on a scale
Standard Deviation 3.491
|
|
Biphasic Ethanol Effects Scale (BAES)
Sedation Effects (Timepoint P150)
|
2.586 score on a scale
Standard Deviation 4.594
|
4.567 score on a scale
Standard Deviation 7.257
|
2.813 score on a scale
Standard Deviation 5.688
|
1.548 score on a scale
Standard Deviation 3.897
|
|
Biphasic Ethanol Effects Scale (BAES)
Stimulation Effects (Timepoint M160)
|
11.2 score on a scale
Standard Deviation 11.152
|
13 score on a scale
Standard Deviation 13.844
|
13.281 score on a scale
Standard Deviation 12.606
|
12.387 score on a scale
Standard Deviation 11.292
|
|
Biphasic Ethanol Effects Scale (BAES)
Stimulation Effects (Timepoint M10)
|
12.567 score on a scale
Standard Deviation 12.297
|
12.903 score on a scale
Standard Deviation 11.47
|
12.188 score on a scale
Standard Deviation 12.678
|
9.129 score on a scale
Standard Deviation 9.57
|
|
Biphasic Ethanol Effects Scale (BAES)
Stimulation Effects (Timepoint 0)
|
13.767 score on a scale
Standard Deviation 12.813
|
14.484 score on a scale
Standard Deviation 13.466
|
10.406 score on a scale
Standard Deviation 12.018
|
8.065 score on a scale
Standard Deviation 9.352
|
|
Biphasic Ethanol Effects Scale (BAES)
Stimulation Effects (Timepoint P15)
|
12.8 score on a scale
Standard Deviation 13.697
|
13.968 score on a scale
Standard Deviation 12.875
|
9.625 score on a scale
Standard Deviation 11.187
|
8.452 score on a scale
Standard Deviation 9.305
|
|
Biphasic Ethanol Effects Scale (BAES)
Stimulation Effects (Timepoint P70)
|
9.233 score on a scale
Standard Deviation 11.193
|
9.839 score on a scale
Standard Deviation 11.827
|
10.125 score on a scale
Standard Deviation 11.853
|
9.903 score on a scale
Standard Deviation 11.324
|
|
Biphasic Ethanol Effects Scale (BAES)
Stimulation Effects (Timepoint P90)
|
8.833 score on a scale
Standard Deviation 10.449
|
9.742 score on a scale
Standard Deviation 12.762
|
10.094 score on a scale
Standard Deviation 11.217
|
9.71 score on a scale
Standard Deviation 11.261
|
|
Biphasic Ethanol Effects Scale (BAES)
Stimulation Effects (Timepoint P150)
|
8.793 score on a scale
Standard Deviation 11.004
|
9.867 score on a scale
Standard Deviation 13.32
|
10.406 score on a scale
Standard Deviation 11.67
|
9.484 score on a scale
Standard Deviation 9.743
|
Adverse Events
Active Ethanol and Active Iomazenil
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Active Ethanol and Placebo Iomazenil
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo Ethanol and Active Iomazenil
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo Ethanol and Placebo Iomazenil
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Active Ethanol and Active Iomazenil
n=30 participants at risk
Each participant will receive in a randomized, double-blind, cross-over design, ethanol or placebo and iomazenil or placebo.
Potential randomizations for each test day: a) active ethanol and placebo iomazenil, b) active ethanol and active iomazenil, c) placebo ethanol and active iomazenil, and d) placebo ethanol and placebo iomazenil
Active Ethanol: Target BrAC of 0.1% reached over 30 minutes and then clamped to maintain this dose for an additional 60 minutes. This dose is equivalent to consuming approximately 5 drinks. Administered over a total of 90 minutes.
Active Iomazenil: Active iomazenil, administered intravenously at a dose of 3.7 ug/kg. Administered over 10 minutes, beginning 10 minutes after the start of the ethanol/placebo clamp.
|
Active Ethanol and Placebo Iomazenil
n=31 participants at risk
Each participant will receive in a randomized, double-blind, cross-over design, ethanol or placebo and iomazenil or placebo.
Potential randomizations for each test day: a) active ethanol and placebo iomazenil, b) active ethanol and active iomazenil, c) placebo ethanol and active iomazenil, and d) placebo ethanol and placebo iomazenil
Active Ethanol: Target BrAC of 0.1% reached over 30 minutes and then clamped to maintain this dose for an additional 60 minutes. This dose is equivalent to consuming approximately 5 drinks. Administered over a total of 90 minutes.
Placebo: Control: no iomazenil, administered for a total of 10 minutes
|
Placebo Ethanol and Active Iomazenil
n=32 participants at risk
Each participant will receive in a randomized, double-blind, cross-over design, ethanol or placebo and iomazenil or placebo.
Potential randomizations for each test day: a) active ethanol and placebo iomazenil, b) active ethanol and active iomazenil, c) placebo ethanol and active iomazenil, and d) placebo ethanol and placebo iomazenil
Active Iomazenil: Active iomazenil, administered intravenously at a dose of 3.7 ug/kg. Administered over 10 minutes, beginning 10 minutes after the start of the ethanol/placebo clamp.
Placebo: Control: no alcohol, administered for a total of 90 minutes.
|
Placebo Ethanol and Placebo Iomazenil
n=32 participants at risk
Each participant will receive in a randomized, double-blind, cross-over design, ethanol or placebo and iomazenil or placebo.
Potential randomizations for each test day: a) active ethanol and placebo iomazenil, b) active ethanol and active iomazenil, c) placebo ethanol and active iomazenil, and d) placebo ethanol and placebo iomazenil
Placebo: Control: no alcohol, administered for a total of 90 minutes.
Placebo: Control: no iomazenil, administered for a total of 10 minutes
|
|---|---|---|---|---|
|
Nervous system disorders
Lightheaded
|
0.00%
0/30 • Adverse event data was collected beginning at the time of screening and for each of the four test days, through to the completion of the study. Follow up data was obtained at 1 week, 1 month, 6 months, and 1 year following the last test day.
Adverse events are reported for each test day condition.
|
0.00%
0/31 • Adverse event data was collected beginning at the time of screening and for each of the four test days, through to the completion of the study. Follow up data was obtained at 1 week, 1 month, 6 months, and 1 year following the last test day.
Adverse events are reported for each test day condition.
|
6.2%
2/32 • Number of events 2 • Adverse event data was collected beginning at the time of screening and for each of the four test days, through to the completion of the study. Follow up data was obtained at 1 week, 1 month, 6 months, and 1 year following the last test day.
Adverse events are reported for each test day condition.
|
0.00%
0/32 • Adverse event data was collected beginning at the time of screening and for each of the four test days, through to the completion of the study. Follow up data was obtained at 1 week, 1 month, 6 months, and 1 year following the last test day.
Adverse events are reported for each test day condition.
|
|
Gastrointestinal disorders
Vomiting
|
6.7%
2/30 • Number of events 2 • Adverse event data was collected beginning at the time of screening and for each of the four test days, through to the completion of the study. Follow up data was obtained at 1 week, 1 month, 6 months, and 1 year following the last test day.
Adverse events are reported for each test day condition.
|
0.00%
0/31 • Adverse event data was collected beginning at the time of screening and for each of the four test days, through to the completion of the study. Follow up data was obtained at 1 week, 1 month, 6 months, and 1 year following the last test day.
Adverse events are reported for each test day condition.
|
0.00%
0/32 • Adverse event data was collected beginning at the time of screening and for each of the four test days, through to the completion of the study. Follow up data was obtained at 1 week, 1 month, 6 months, and 1 year following the last test day.
Adverse events are reported for each test day condition.
|
0.00%
0/32 • Adverse event data was collected beginning at the time of screening and for each of the four test days, through to the completion of the study. Follow up data was obtained at 1 week, 1 month, 6 months, and 1 year following the last test day.
Adverse events are reported for each test day condition.
|
|
Gastrointestinal disorders
Nausea
|
6.7%
2/30 • Number of events 2 • Adverse event data was collected beginning at the time of screening and for each of the four test days, through to the completion of the study. Follow up data was obtained at 1 week, 1 month, 6 months, and 1 year following the last test day.
Adverse events are reported for each test day condition.
|
0.00%
0/31 • Adverse event data was collected beginning at the time of screening and for each of the four test days, through to the completion of the study. Follow up data was obtained at 1 week, 1 month, 6 months, and 1 year following the last test day.
Adverse events are reported for each test day condition.
|
0.00%
0/32 • Adverse event data was collected beginning at the time of screening and for each of the four test days, through to the completion of the study. Follow up data was obtained at 1 week, 1 month, 6 months, and 1 year following the last test day.
Adverse events are reported for each test day condition.
|
0.00%
0/32 • Adverse event data was collected beginning at the time of screening and for each of the four test days, through to the completion of the study. Follow up data was obtained at 1 week, 1 month, 6 months, and 1 year following the last test day.
Adverse events are reported for each test day condition.
|
|
Nervous system disorders
Dizziness
|
3.3%
1/30 • Number of events 1 • Adverse event data was collected beginning at the time of screening and for each of the four test days, through to the completion of the study. Follow up data was obtained at 1 week, 1 month, 6 months, and 1 year following the last test day.
Adverse events are reported for each test day condition.
|
3.2%
1/31 • Number of events 1 • Adverse event data was collected beginning at the time of screening and for each of the four test days, through to the completion of the study. Follow up data was obtained at 1 week, 1 month, 6 months, and 1 year following the last test day.
Adverse events are reported for each test day condition.
|
3.1%
1/32 • Number of events 1 • Adverse event data was collected beginning at the time of screening and for each of the four test days, through to the completion of the study. Follow up data was obtained at 1 week, 1 month, 6 months, and 1 year following the last test day.
Adverse events are reported for each test day condition.
|
0.00%
0/32 • Adverse event data was collected beginning at the time of screening and for each of the four test days, through to the completion of the study. Follow up data was obtained at 1 week, 1 month, 6 months, and 1 year following the last test day.
Adverse events are reported for each test day condition.
|
|
Gastrointestinal disorders
Stomach Cramps
|
0.00%
0/30 • Adverse event data was collected beginning at the time of screening and for each of the four test days, through to the completion of the study. Follow up data was obtained at 1 week, 1 month, 6 months, and 1 year following the last test day.
Adverse events are reported for each test day condition.
|
0.00%
0/31 • Adverse event data was collected beginning at the time of screening and for each of the four test days, through to the completion of the study. Follow up data was obtained at 1 week, 1 month, 6 months, and 1 year following the last test day.
Adverse events are reported for each test day condition.
|
3.1%
1/32 • Number of events 1 • Adverse event data was collected beginning at the time of screening and for each of the four test days, through to the completion of the study. Follow up data was obtained at 1 week, 1 month, 6 months, and 1 year following the last test day.
Adverse events are reported for each test day condition.
|
0.00%
0/32 • Adverse event data was collected beginning at the time of screening and for each of the four test days, through to the completion of the study. Follow up data was obtained at 1 week, 1 month, 6 months, and 1 year following the last test day.
Adverse events are reported for each test day condition.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/30 • Adverse event data was collected beginning at the time of screening and for each of the four test days, through to the completion of the study. Follow up data was obtained at 1 week, 1 month, 6 months, and 1 year following the last test day.
Adverse events are reported for each test day condition.
|
0.00%
0/31 • Adverse event data was collected beginning at the time of screening and for each of the four test days, through to the completion of the study. Follow up data was obtained at 1 week, 1 month, 6 months, and 1 year following the last test day.
Adverse events are reported for each test day condition.
|
3.1%
1/32 • Number of events 1 • Adverse event data was collected beginning at the time of screening and for each of the four test days, through to the completion of the study. Follow up data was obtained at 1 week, 1 month, 6 months, and 1 year following the last test day.
Adverse events are reported for each test day condition.
|
0.00%
0/32 • Adverse event data was collected beginning at the time of screening and for each of the four test days, through to the completion of the study. Follow up data was obtained at 1 week, 1 month, 6 months, and 1 year following the last test day.
Adverse events are reported for each test day condition.
|
Additional Information
Deepak Cyril D'Souza, MD
VA Connecticut Healthcare System
Phone: 203-932-5711
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place