Trial Outcomes & Findings for Healthy Volunteers Study of the Effects of Olanzapine and Ziprasidone (NCT NCT00910988)
NCT ID: NCT00910988
Last Updated: 2018-07-18
Results Overview
To evaluate, using a within-subject placebo-controlled comparison, the acute effects of olanzapine or ziprasidone administration on insulin sensitivity in antipsychotic-naïve healthy young men, measured as whole-body dextrose infusion rates (mg/kg/min).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
46 participants
Primary outcome timeframe
approximately 3 hours
Results posted on
2018-07-18
Participant Flow
Participant milestones
| Measure |
Olanzapine (Drug First)
Subjects from this group received an olanzapine injection at the first clamp followed by a saline injection at the second clamp.
|
Ziprasidone (Drug First)
Subjects from this group received a ziprasidone injection at the first clamp followed by a saline injection at the second clamp.
|
Olanzapine (Placebo First)
Subjects from this group received a saline injection at the first clamp followed by an olanzapine injection at the second clamp.
|
Ziprasidone (Placebo First)
Subjects from this group received a saline injection at the first clamp followed by a ziprasidone injection at the second clamp.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
16
|
16
|
8
|
6
|
|
Overall Study
COMPLETED
|
14
|
12
|
5
|
6
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
3
|
0
|
Reasons for withdrawal
| Measure |
Olanzapine (Drug First)
Subjects from this group received an olanzapine injection at the first clamp followed by a saline injection at the second clamp.
|
Ziprasidone (Drug First)
Subjects from this group received a ziprasidone injection at the first clamp followed by a saline injection at the second clamp.
|
Olanzapine (Placebo First)
Subjects from this group received a saline injection at the first clamp followed by an olanzapine injection at the second clamp.
|
Ziprasidone (Placebo First)
Subjects from this group received a saline injection at the first clamp followed by a ziprasidone injection at the second clamp.
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
4
|
3
|
0
|
Baseline Characteristics
Healthy Volunteers Study of the Effects of Olanzapine and Ziprasidone
Baseline characteristics by cohort
| Measure |
Olanzapine (Drug First)
n=16 Participants
Subjects from this group received an olanzapine injection at the first clamp followed by a saline injection at the second clamp.
|
Ziprasidone (Drug First)
n=16 Participants
Subjects from this group received a ziprasidone injection at the first clamp followed by a saline injection at the second clamp.
|
Olanzapine (Placebo First)
n=8 Participants
Subjects from this group received a saline injection at the first clamp followed by an olanzapine injection at the second clamp.
|
Ziprasidone (Placebo First)
n=6 Participants
Subjects from this group received a saline injection at the first clamp followed by a ziprasidone injection at the second clamp.
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
34.5 years
STANDARD_DEVIATION 9.1 • n=5 Participants
|
32.9 years
STANDARD_DEVIATION 9.0 • n=7 Participants
|
37.0 years
STANDARD_DEVIATION 5.6 • n=5 Participants
|
29.7 years
STANDARD_DEVIATION 8.7 • n=4 Participants
|
33.5 years
STANDARD_DEVIATION 8.5 • n=21 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
46 Participants
n=21 Participants
|
|
Sex/Gender, Customized
Female
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
|
Sex/Gender, Customized
Male
|
14 participants
n=5 Participants
|
12 participants
n=7 Participants
|
5 participants
n=5 Participants
|
6 participants
n=4 Participants
|
37 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
5 participants
n=5 Participants
|
7 participants
n=7 Participants
|
1 participants
n=5 Participants
|
4 participants
n=4 Participants
|
17 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
African American
|
9 participants
n=5 Participants
|
6 participants
n=7 Participants
|
7 participants
n=5 Participants
|
2 participants
n=4 Participants
|
24 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
2 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Native American
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
2 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
|
Weight
|
94.6 kilograms
STANDARD_DEVIATION 10.9 • n=5 Participants
|
96.7 kilograms
STANDARD_DEVIATION 10.7 • n=7 Participants
|
113.1 kilograms
STANDARD_DEVIATION 9.4 • n=5 Participants
|
96.2 kilograms
STANDARD_DEVIATION 6.0 • n=4 Participants
|
98.0 kilograms
STANDARD_DEVIATION 11.4 • n=21 Participants
|
|
Body Mass Index (BMI)
|
29.60 kg/m^2
STANDARD_DEVIATION 2.13 • n=5 Participants
|
30.86 kg/m^2
STANDARD_DEVIATION 2.82 • n=7 Participants
|
33.18 kg/m^2
STANDARD_DEVIATION 1.56 • n=5 Participants
|
30.84 kg/m^2
STANDARD_DEVIATION 1.45 • n=4 Participants
|
30.69 kg/m^2
STANDARD_DEVIATION 2.44 • n=21 Participants
|
|
Waist Circumference
|
102.0 centimeters
STANDARD_DEVIATION 8.3 • n=5 Participants
|
104.3 centimeters
STANDARD_DEVIATION 10.7 • n=7 Participants
|
111.4 centimeters
STANDARD_DEVIATION 4.2 • n=5 Participants
|
106.2 centimeters
STANDARD_DEVIATION 8.7 • n=4 Participants
|
104.7 centimeters
STANDARD_DEVIATION 9.0 • n=21 Participants
|
|
DEXA Total Fat
|
25.8 kilograms
STANDARD_DEVIATION 7.3 • n=5 Participants
|
26.9 kilograms
STANDARD_DEVIATION 7.4 • n=7 Participants
|
30.4 kilograms
STANDARD_DEVIATION 6.9 • n=5 Participants
|
27.8 kilograms
STANDARD_DEVIATION 5.5 • n=4 Participants
|
27.1 kilograms
STANDARD_DEVIATION 6.9 • n=21 Participants
|
|
Systolic Blood Pressure
|
130 mmHg
STANDARD_DEVIATION 10 • n=5 Participants
|
130 mmHg
STANDARD_DEVIATION 7 • n=7 Participants
|
134 mmHg
STANDARD_DEVIATION 17 • n=5 Participants
|
130 mmHg
STANDARD_DEVIATION 10 • n=4 Participants
|
131 mmHg
STANDARD_DEVIATION 10 • n=21 Participants
|
|
Diastolic Blood Pressure
|
80 mmHg
STANDARD_DEVIATION 8 • n=5 Participants
|
77 mmHg
STANDARD_DEVIATION 6 • n=7 Participants
|
82 mmHg
STANDARD_DEVIATION 15 • n=5 Participants
|
71 mmHg
STANDARD_DEVIATION 10 • n=4 Participants
|
78 mmHg
STANDARD_DEVIATION 9 • n=21 Participants
|
|
Heart Rate
|
67 beats per minute
STANDARD_DEVIATION 12 • n=5 Participants
|
71 beats per minute
STANDARD_DEVIATION 11 • n=7 Participants
|
57 beats per minute
STANDARD_DEVIATION 5 • n=5 Participants
|
66 beats per minute
STANDARD_DEVIATION 7 • n=4 Participants
|
67 beats per minute
STANDARD_DEVIATION 11 • n=21 Participants
|
|
Fasting Cholesterol
|
191.9 mg/dL
STANDARD_DEVIATION 41.4 • n=5 Participants
|
169.6 mg/dL
STANDARD_DEVIATION 37.6 • n=7 Participants
|
176.8 mg/dL
STANDARD_DEVIATION 38.4 • n=5 Participants
|
175.3 mg/dL
STANDARD_DEVIATION 24.2 • n=4 Participants
|
179.9 mg/dL
STANDARD_DEVIATION 37.3 • n=21 Participants
|
|
Fasting HDL Cholesterol
|
42.3 mg/dL
STANDARD_DEVIATION 17.1 • n=5 Participants
|
38.9 mg/dL
STANDARD_DEVIATION 9.6 • n=7 Participants
|
43.4 mg/dL
STANDARD_DEVIATION 11.1 • n=5 Participants
|
29.2 mg/dL
STANDARD_DEVIATION 6.5 • n=4 Participants
|
39.2 mg/dL
STANDARD_DEVIATION 13.3 • n=21 Participants
|
|
Fasting Triglycerides
|
152.8 mg/dL
STANDARD_DEVIATION 55.5 • n=5 Participants
|
122.0 mg/dL
STANDARD_DEVIATION 62.1 • n=7 Participants
|
128.6 mg/dL
STANDARD_DEVIATION 79.3 • n=5 Participants
|
171.0 mg/dL
STANDARD_DEVIATION 55.2 • n=4 Participants
|
142.5 mg/dL
STANDARD_DEVIATION 61.3 • n=21 Participants
|
|
Fasting LDL Cholesterol
|
117.9 mg/dL
STANDARD_DEVIATION 33.5 • n=5 Participants
|
105.2 mg/dL
STANDARD_DEVIATION 26.3 • n=7 Participants
|
104.2 mg/dL
STANDARD_DEVIATION 38.5 • n=5 Participants
|
116.3 mg/dL
STANDARD_DEVIATION 27.2 • n=4 Participants
|
111.6 mg/dL
STANDARD_DEVIATION 30.4 • n=21 Participants
|
|
Fasting Insulin
|
16.6 uIU/mL
STANDARD_DEVIATION 11.5 • n=5 Participants
|
13.6 uIU/mL
STANDARD_DEVIATION 5.5 • n=7 Participants
|
20.0 uIU/mL
STANDARD_DEVIATION 9.5 • n=5 Participants
|
17.0 uIU/mL
STANDARD_DEVIATION 10.4 • n=4 Participants
|
16.2 uIU/mL
STANDARD_DEVIATION 9.3 • n=21 Participants
|
PRIMARY outcome
Timeframe: approximately 3 hoursPopulation: The analysis was per protocol and involved subjects who completed both a clamp that involved an injection of either olanzapine or ziprasidone, and a clamp that involved a placebo injection. Nine subjects did not complete a second clamp as they were lost to follow-up. This resulted in the analysis of 37 participants.
To evaluate, using a within-subject placebo-controlled comparison, the acute effects of olanzapine or ziprasidone administration on insulin sensitivity in antipsychotic-naïve healthy young men, measured as whole-body dextrose infusion rates (mg/kg/min).
Outcome measures
| Measure |
Olanzapine (Drug/Placebo)-Drug
n=14 Participants
Subjects from this group received olanzapine (10 mg per IM injection) and will receive normal saline at the next visit.
|
Olanzapine (Drug/Placebo)-Placebo
n=14 Participants
Subjects from this group received 0.9% normal saline (1 ml per IM injection) while having received olanzapine at the previous visit.
|
Olanzapine (Placebo/Drug)-Placebo
n=5 Participants
Subjects from this group received 0.9% normal saline (1 ml per IM injection) and will receive olanzapine at the next visit.
|
Olanzapine (Placebo/Drug)-Drug
n=5 Participants
Subjects from this group received olanzapine (10 mg per IM injection) while having received normal saline at previous visit.
|
Ziprasidone (Placebo/Drug)-Placebo
n=6 Participants
Subjects from this group received 0.9% normal saline (1 ml per IM injection) and will receive ziprasidone at the next visit.
|
Ziprasidone (Placebo/Drug)-Drug
n=6 Participants
Subjects from this group received ziprasidone (20 mg per IM injection) while having received normal saline at previous visit.
|
Ziprasidone (Drug/Placebo)-Drug
n=12 Participants
Subjects from this group received ziprasidone (20 mg per IM injection) and will receive normal saline at the next visit.
|
Ziprasidone (Drug/Placebo)-Placebo
n=12 Participants
Subjects from this group received 0.9% normal saline (1 ml per IM injection) while having received ziprasidone at the previous visit.
|
|---|---|---|---|---|---|---|---|---|
|
Whole Body Insulin Sensitivity
|
4.9 mg/kg/min
Standard Deviation 2.2
|
5.4 mg/kg/min
Standard Deviation 2.6
|
4.1 mg/kg/min
Standard Deviation 1.2
|
2.9 mg/kg/min
Standard Deviation 1.0
|
5.8 mg/kg/min
Standard Deviation 2.2
|
4.7 mg/kg/min
Standard Deviation 1.8
|
4.5 mg/kg/min
Standard Deviation 3.1
|
5.3 mg/kg/min
Standard Deviation 3.3
|
PRIMARY outcome
Timeframe: approximately 3 hoursPopulation: The analysis was per protocol and involved subjects who completed both a clamp that involved an injection of either olanzapine or ziprasidone, and a clamp that involved a placebo injection. Nine subjects did not complete a second clamp as they were lost to follow-up. This resulted in the analysis of 37 participants.
To evaluate, using a within-subject placebo-controlled comparison, the acute effects of olanzapine or ziprasidone administration on insulin sensitivity in antipsychotic-naïve healthy young men, measured as hepatic glucose production (glucose rate of appearance \[Ra\]).
Outcome measures
| Measure |
Olanzapine (Drug/Placebo)-Drug
n=14 Participants
Subjects from this group received olanzapine (10 mg per IM injection) and will receive normal saline at the next visit.
|
Olanzapine (Drug/Placebo)-Placebo
n=14 Participants
Subjects from this group received 0.9% normal saline (1 ml per IM injection) while having received olanzapine at the previous visit.
|
Olanzapine (Placebo/Drug)-Placebo
n=5 Participants
Subjects from this group received 0.9% normal saline (1 ml per IM injection) and will receive olanzapine at the next visit.
|
Olanzapine (Placebo/Drug)-Drug
n=5 Participants
Subjects from this group received olanzapine (10 mg per IM injection) while having received normal saline at previous visit.
|
Ziprasidone (Placebo/Drug)-Placebo
n=6 Participants
Subjects from this group received 0.9% normal saline (1 ml per IM injection) and will receive ziprasidone at the next visit.
|
Ziprasidone (Placebo/Drug)-Drug
n=6 Participants
Subjects from this group received ziprasidone (20 mg per IM injection) while having received normal saline at previous visit.
|
Ziprasidone (Drug/Placebo)-Drug
n=12 Participants
Subjects from this group received ziprasidone (20 mg per IM injection) and will receive normal saline at the next visit.
|
Ziprasidone (Drug/Placebo)-Placebo
n=12 Participants
Subjects from this group received 0.9% normal saline (1 ml per IM injection) while having received ziprasidone at the previous visit.
|
|---|---|---|---|---|---|---|---|---|
|
Hepatic Insulin Sensitivity
|
81.0 % change from basal to insulin phase
Standard Deviation 9.4
|
79.1 % change from basal to insulin phase
Standard Deviation 6.1
|
73.1 % change from basal to insulin phase
Standard Deviation 16.2
|
78.5 % change from basal to insulin phase
Standard Deviation 8.1
|
84.0 % change from basal to insulin phase
Standard Deviation 13.5
|
80.7 % change from basal to insulin phase
Standard Deviation 8.5
|
82.1 % change from basal to insulin phase
Standard Deviation 8.6
|
83.4 % change from basal to insulin phase
Standard Deviation 6.8
|
PRIMARY outcome
Timeframe: approximately 3 hoursPopulation: The analysis was per protocol and involved subjects who completed both a clamp that involved an injection of either olanzapine or ziprasidone, and a clamp that involved a placebo injection. Nine subjects did not complete a second clamp as they were lost to follow-up. This resulted in the analysis of 37 participants.
To evaluate, using a within-subject placebo-controlled comparison, the acute effects of olanzapine or ziprasidone administration on insulin sensitivity in antipsychotic-naïve healthy young men, measured as primarily muscle glucose utilization (glucose rate of disappearance \[Rd\]).
Outcome measures
| Measure |
Olanzapine (Drug/Placebo)-Drug
n=14 Participants
Subjects from this group received olanzapine (10 mg per IM injection) and will receive normal saline at the next visit.
|
Olanzapine (Drug/Placebo)-Placebo
n=14 Participants
Subjects from this group received 0.9% normal saline (1 ml per IM injection) while having received olanzapine at the previous visit.
|
Olanzapine (Placebo/Drug)-Placebo
n=5 Participants
Subjects from this group received 0.9% normal saline (1 ml per IM injection) and will receive olanzapine at the next visit.
|
Olanzapine (Placebo/Drug)-Drug
n=5 Participants
Subjects from this group received olanzapine (10 mg per IM injection) while having received normal saline at previous visit.
|
Ziprasidone (Placebo/Drug)-Placebo
n=6 Participants
Subjects from this group received 0.9% normal saline (1 ml per IM injection) and will receive ziprasidone at the next visit.
|
Ziprasidone (Placebo/Drug)-Drug
n=6 Participants
Subjects from this group received ziprasidone (20 mg per IM injection) while having received normal saline at previous visit.
|
Ziprasidone (Drug/Placebo)-Drug
n=12 Participants
Subjects from this group received ziprasidone (20 mg per IM injection) and will receive normal saline at the next visit.
|
Ziprasidone (Drug/Placebo)-Placebo
n=12 Participants
Subjects from this group received 0.9% normal saline (1 ml per IM injection) while having received ziprasidone at the previous visit.
|
|---|---|---|---|---|---|---|---|---|
|
Peripheral Insulin Sensitivity
|
152.2 % change from basal to insulin phase
Standard Deviation 88.0
|
183.5 % change from basal to insulin phase
Standard Deviation 130.7
|
157.0 % change from basal to insulin phase
Standard Deviation 72.2
|
83.7 % change from basal to insulin phase
Standard Deviation 60.5
|
208.2 % change from basal to insulin phase
Standard Deviation 96.0
|
161.0 % change from basal to insulin phase
Standard Deviation 85.0
|
135.6 % change from basal to insulin phase
Standard Deviation 128.4
|
185.3 % change from basal to insulin phase
Standard Deviation 136.5
|
PRIMARY outcome
Timeframe: approximately 3 hoursPopulation: The analysis was per protocol and involved subjects who completed both a clamp that involved an injection of either olanzapine or ziprasidone, and a clamp that involved a placebo injection. Nine subjects did not complete a second clamp as they were lost to follow-up. This resulted in the analysis of 37 participants.
To evaluate, using a within-subject placebo-controlled comparison, the acute effects of olanzapine or ziprasidone administration on insulin sensitivity in antipsychotic-naïve healthy young men, measured as free fatty acid release (glycerol rate of appearance \[Ra\]).
Outcome measures
| Measure |
Olanzapine (Drug/Placebo)-Drug
n=14 Participants
Subjects from this group received olanzapine (10 mg per IM injection) and will receive normal saline at the next visit.
|
Olanzapine (Drug/Placebo)-Placebo
n=14 Participants
Subjects from this group received 0.9% normal saline (1 ml per IM injection) while having received olanzapine at the previous visit.
|
Olanzapine (Placebo/Drug)-Placebo
n=5 Participants
Subjects from this group received 0.9% normal saline (1 ml per IM injection) and will receive olanzapine at the next visit.
|
Olanzapine (Placebo/Drug)-Drug
n=5 Participants
Subjects from this group received olanzapine (10 mg per IM injection) while having received normal saline at previous visit.
|
Ziprasidone (Placebo/Drug)-Placebo
n=6 Participants
Subjects from this group received 0.9% normal saline (1 ml per IM injection) and will receive ziprasidone at the next visit.
|
Ziprasidone (Placebo/Drug)-Drug
n=6 Participants
Subjects from this group received ziprasidone (20 mg per IM injection) while having received normal saline at previous visit.
|
Ziprasidone (Drug/Placebo)-Drug
n=12 Participants
Subjects from this group received ziprasidone (20 mg per IM injection) and will receive normal saline at the next visit.
|
Ziprasidone (Drug/Placebo)-Placebo
n=12 Participants
Subjects from this group received 0.9% normal saline (1 ml per IM injection) while having received ziprasidone at the previous visit.
|
|---|---|---|---|---|---|---|---|---|
|
Adipose Tissue Insulin Sensitivity
|
43.3 % change from basal to insulin phase
Standard Deviation 13.2
|
45.2 % change from basal to insulin phase
Standard Deviation 15.8
|
52.8 % change from basal to insulin phase
Standard Deviation 13.8
|
53.1 % change from basal to insulin phase
Standard Deviation 14.4
|
39.5 % change from basal to insulin phase
Standard Deviation 14.6
|
37.6 % change from basal to insulin phase
Standard Deviation 8.9
|
47.8 % change from basal to insulin phase
Standard Deviation 11.7
|
44.4 % change from basal to insulin phase
Standard Deviation 12.1
|
Adverse Events
Olanzapine, to be Followed by Normal Saline
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Normal Saline, Following Olanzapine
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Normal Saline, to be Followed by Olanzapine
Serious events: 0 serious events
Other events: 63 other events
Deaths: 0 deaths
Olanzapine, Following Normal Saline
Serious events: 0 serious events
Other events: 82 other events
Deaths: 0 deaths
Normal Saline, to be Followed by Ziprasidone
Serious events: 0 serious events
Other events: 72 other events
Deaths: 0 deaths
Ziprasidone, Following Normal Saline
Serious events: 0 serious events
Other events: 88 other events
Deaths: 0 deaths
Ziprasidone, to be Followed by Normal Saline
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Normal Saline, Following Ziprasidone
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Olanzapine, to be Followed by Normal Saline
n=14 participants at risk
Subjects from this group received olanzapine (10 mg per IM injection) and will receive normal saline at the next visit.
|
Normal Saline, Following Olanzapine
n=14 participants at risk
Subjects from this group received 0.9% normal saline (1 ml per IM injection) while having received olanzapine at the previous visit.
|
Normal Saline, to be Followed by Olanzapine
n=5 participants at risk
Subjects from this group received 0.9% normal saline (1 ml per IM injection) and will receive olanzapine at the next visit.
|
Olanzapine, Following Normal Saline
n=5 participants at risk
Subjects from this group received olanzapine (10 mg per IM injection) while having received normal saline at previous visit.
|
Normal Saline, to be Followed by Ziprasidone
n=6 participants at risk
Subjects from this group received 0.9% normal saline (1 ml per IM injection) and will receive ziprasidone at the next visit.
|
Ziprasidone, Following Normal Saline
n=6 participants at risk
Subjects from this group received ziprasidone (20 mg per IM injection) while having received normal saline at previous visit.
|
Ziprasidone, to be Followed by Normal Saline
n=12 participants at risk
Subjects from this group received ziprasidone (20 mg per IM injection) and will receive normal saline at the next visit.
|
Normal Saline, Following Ziprasidone
n=12 participants at risk
Subjects from this group received 0.9% normal saline (1 ml per IM injection) while having received ziprasidone at the previous visit.
|
|---|---|---|---|---|---|---|---|---|
|
General disorders
Itching, rash, or hives-during past week
|
0.00%
0/14
|
7.1%
1/14
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/6
|
16.7%
1/6
|
8.3%
1/12
|
8.3%
1/12
|
|
General disorders
Chest pain-during past week
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/5
|
20.0%
1/5
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/12
|
|
General disorders
Heart palpitations-during past week
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/12
|
|
General disorders
Dizziness-during past week
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/5
|
20.0%
1/5
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/12
|
|
General disorders
Dizziness-30 minutes post injection
|
7.1%
1/14
|
7.1%
1/14
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/12
|
|
Gastrointestinal disorders
Dizziness-1 hour post meal
|
0.00%
0/14
|
7.1%
1/14
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/12
|
|
General disorders
Dizziness-prior to discharge
|
16.7%
1/6
|
0.00%
0/14
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/12
|
|
General disorders
Angry or agitated-during past week
|
7.1%
1/14
|
7.1%
1/14
|
20.0%
1/5
|
0.00%
0/5
|
33.3%
2/6
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/12
|
|
General disorders
Angry or agitated-prior to injection
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/12
|
|
General disorders
Angry or agitated-end of clamp
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/5
|
40.0%
2/5
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/12
|
|
General disorders
Confused-30 minutes post injection
|
7.1%
1/14
|
0.00%
0/14
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/12
|
|
General disorders
Confused-end of clamp
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/5
|
20.0%
1/5
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/12
|
|
General disorders
Headache-during past week
|
21.4%
3/14
|
21.4%
3/14
|
60.0%
3/5
|
40.0%
2/5
|
0.00%
0/6
|
0.00%
0/6
|
8.3%
1/12
|
8.3%
1/12
|
|
General disorders
Headache-prior to injection
|
7.1%
1/14
|
0.00%
0/14
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/12
|
|
General disorders
Headache-30 minutes post injection
|
14.3%
2/14
|
0.00%
0/14
|
20.0%
1/5
|
20.0%
1/5
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/12
|
|
General disorders
Headache-end of clamp
|
0.00%
0/14
|
7.1%
1/14
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/12
|
|
General disorders
Sad, blue, or depressed-during past week
|
7.1%
1/14
|
0.00%
0/14
|
0.00%
0/5
|
0.00%
0/5
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/12
|
|
General disorders
Worried, anxious-during past week
|
28.6%
4/14
|
21.4%
3/14
|
20.0%
1/5
|
0.00%
0/5
|
16.7%
1/6
|
16.7%
1/6
|
16.7%
2/12
|
8.3%
1/12
|
|
General disorders
Worried, anxious-prior to injection
|
21.4%
3/14
|
14.3%
2/14
|
20.0%
1/5
|
0.00%
0/5
|
33.3%
2/6
|
0.00%
0/6
|
25.0%
3/12
|
8.3%
1/12
|
|
General disorders
Worried, anxious-30 minutes post injection
|
7.1%
1/14
|
0.00%
0/14
|
0.00%
0/5
|
0.00%
0/5
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/12
|
|
General disorders
Worried, anxious-end of clamp
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/5
|
40.0%
2/5
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/12
|
|
General disorders
Tiredness, fatigue-during past week
|
35.7%
5/14
|
28.6%
4/14
|
40.0%
2/5
|
40.0%
2/5
|
50.0%
3/6
|
66.7%
4/6
|
33.3%
4/12
|
50.0%
6/12
|
|
General disorders
Tiredness, fatigue-prior to injection
|
35.7%
5/14
|
21.4%
3/14
|
40.0%
2/5
|
60.0%
3/5
|
50.0%
3/6
|
50.0%
3/6
|
41.7%
5/12
|
41.7%
5/12
|
|
General disorders
Tiredness, fatigue-30 minutes post injection
|
64.3%
9/14
|
21.4%
3/14
|
20.0%
1/5
|
20.0%
1/5
|
50.0%
3/6
|
66.7%
4/6
|
50.0%
6/12
|
58.3%
7/12
|
|
General disorders
Tiredness, fatigue-end of clamp
|
64.3%
9/14
|
21.4%
3/14
|
40.0%
2/5
|
60.0%
3/5
|
33.3%
2/6
|
66.7%
4/6
|
83.3%
10/12
|
41.7%
5/12
|
|
General disorders
Tiredness, fatigue-1 hour post meal
|
57.1%
8/14
|
7.1%
1/14
|
0.00%
0/5
|
60.0%
3/5
|
16.7%
1/6
|
50.0%
3/6
|
75.0%
9/12
|
25.0%
3/12
|
|
General disorders
Tiredness, fatigue-prior to discharge
|
71.4%
5/7
|
0.00%
0/14
|
0.00%
0/5
|
66.7%
2/3
|
0.00%
0/6
|
0.00%
0/6
|
40.0%
2/5
|
0.00%
0/12
|
|
General disorders
Dry mouth, thirsty-during past week
|
14.3%
2/14
|
7.1%
1/14
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/12
|
|
General disorders
Dry mouth, thirsty-prior to injection
|
14.3%
2/14
|
7.1%
1/14
|
0.00%
0/5
|
0.00%
0/5
|
16.7%
1/6
|
0.00%
0/6
|
25.0%
3/12
|
0.00%
0/12
|
|
General disorders
Dry mouth, thirsty-30 minutes post injection
|
21.4%
3/14
|
14.3%
2/14
|
0.00%
0/5
|
20.0%
1/5
|
33.3%
2/6
|
33.3%
2/6
|
33.3%
4/12
|
25.0%
3/12
|
|
General disorders
Dry mouth, thirsty-end of clamp
|
7.1%
1/14
|
14.3%
2/14
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
2/12
|
0.00%
0/12
|
|
General disorders
Dry mouth, thirsty-1 hour post meal
|
7.1%
1/14
|
0.00%
0/14
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/12
|
|
General disorders
Extra saliva-during past week
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/6
|
8.3%
1/12
|
8.3%
1/12
|
|
General disorders
Constipation, diarrhea-during past week
|
0.00%
0/14
|
7.1%
1/14
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/12
|
|
General disorders
Fever-during past week
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/12
|
|
General disorders
Hypotension-end of clamp
|
28.6%
4/14
|
0.00%
0/14
|
0.00%
0/5
|
20.0%
1/5
|
0.00%
0/6
|
16.7%
1/6
|
41.7%
5/12
|
0.00%
0/12
|
|
General disorders
Hypotension-1 hour post meal
|
7.1%
1/14
|
0.00%
0/14
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/12
|
|
General disorders
Drowsiness, somnolence-during past week
|
35.7%
5/14
|
28.6%
4/14
|
40.0%
2/5
|
40.0%
2/5
|
33.3%
2/6
|
66.7%
4/6
|
25.0%
3/12
|
50.0%
6/12
|
|
General disorders
Drowsiness, somnolence-prior to injection
|
35.7%
5/14
|
42.9%
6/14
|
40.0%
2/5
|
80.0%
4/5
|
50.0%
3/6
|
50.0%
3/6
|
33.3%
4/12
|
41.7%
5/12
|
|
General disorders
Drowsiness, somnolence-30 minutes post injection
|
85.7%
12/14
|
35.7%
5/14
|
40.0%
2/5
|
80.0%
4/5
|
50.0%
3/6
|
100.0%
6/6
|
66.7%
8/12
|
50.0%
6/12
|
|
General disorders
Drowsiness, somnolence-end of clamp
|
78.6%
11/14
|
21.4%
3/14
|
60.0%
3/5
|
100.0%
5/5
|
16.7%
1/6
|
100.0%
6/6
|
100.0%
12/12
|
16.7%
2/12
|
|
General disorders
Drowsiness, somnolence-1 hour post meal
|
85.7%
12/14
|
0.00%
0/14
|
0.00%
0/5
|
80.0%
4/5
|
16.7%
1/6
|
50.0%
3/6
|
75.0%
9/12
|
0.00%
0/12
|
|
General disorders
Drowsiness, somnolence-prior to discharge
|
44.4%
4/9
|
0.00%
0/14
|
0.00%
0/5
|
66.7%
2/3
|
0.00%
0/6
|
100.0%
1/1
|
40.0%
2/5
|
0.00%
0/12
|
|
General disorders
Stiff muscles or jaw-during past week
|
14.3%
2/14
|
7.1%
1/14
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/6
|
16.7%
1/6
|
8.3%
1/12
|
8.3%
1/12
|
|
General disorders
Stiff muscles or jaw-30 minutes post injection
|
7.1%
1/14
|
14.3%
2/14
|
20.0%
1/5
|
0.00%
0/5
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/12
|
8.3%
1/12
|
|
General disorders
Stiff muscles or jaw-end of clamp
|
7.1%
1/14
|
14.3%
2/14
|
40.0%
2/5
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/12
|
8.3%
1/12
|
|
General disorders
Stiff muscles or jaw-1 hour post meal
|
7.1%
1/14
|
7.1%
1/14
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/12
|
|
General disorders
Muscle tenderness-during past week
|
7.1%
1/14
|
14.3%
2/14
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/12
|
|
General disorders
Muscle tenderness-30 minutes post injection
|
7.1%
1/14
|
7.1%
1/14
|
0.00%
0/5
|
0.00%
0/5
|
16.7%
1/6
|
16.7%
1/6
|
8.3%
1/12
|
0.00%
0/12
|
|
General disorders
Muscle tenderness-1 hour post meal
|
0.00%
0/14
|
0.00%
0/14
|
20.0%
1/5
|
20.0%
1/5
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/12
|
|
General disorders
Big appetite-during past week
|
57.1%
8/14
|
42.9%
6/14
|
100.0%
5/5
|
80.0%
4/5
|
83.3%
5/6
|
50.0%
3/6
|
75.0%
9/12
|
58.3%
7/12
|
|
General disorders
Trouble sleeping-during past week
|
42.9%
6/14
|
21.4%
3/14
|
40.0%
2/5
|
20.0%
1/5
|
83.3%
5/6
|
100.0%
6/6
|
41.7%
5/12
|
33.3%
4/12
|
|
General disorders
Heartburn-during past week
|
14.3%
2/14
|
21.4%
3/14
|
40.0%
2/5
|
40.0%
2/5
|
0.00%
0/6
|
16.7%
1/6
|
16.7%
2/12
|
25.0%
3/12
|
|
General disorders
Shakiness-during past week
|
7.1%
1/14
|
0.00%
0/14
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/12
|
|
General disorders
Involuntary movements-during past week
|
0.00%
0/14
|
0.00%
0/14
|
20.0%
1/5
|
0.00%
0/5
|
16.7%
1/6
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/12
|
|
General disorders
Involuntary movements-30 minutes post injection
|
0.00%
0/14
|
0.00%
0/14
|
20.0%
1/5
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/12
|
|
General disorders
Involuntary movements-end of clamp
|
7.1%
1/14
|
0.00%
0/14
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/12
|
|
General disorders
Restlessness-during past week
|
14.3%
2/14
|
0.00%
0/14
|
0.00%
0/5
|
0.00%
0/5
|
16.7%
1/6
|
16.7%
1/6
|
8.3%
1/12
|
0.00%
0/12
|
|
General disorders
Restlessness-prior to injection
|
21.4%
3/14
|
14.3%
2/14
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/6
|
8.3%
1/12
|
8.3%
1/12
|
|
General disorders
Restlessness-30 minutes post injection
|
28.6%
4/14
|
7.1%
1/14
|
20.0%
1/5
|
20.0%
1/5
|
33.3%
2/6
|
33.3%
2/6
|
16.7%
2/12
|
0.00%
0/12
|
|
General disorders
Restlessness-end of clamp
|
64.3%
9/14
|
21.4%
3/14
|
20.0%
1/5
|
40.0%
2/5
|
16.7%
1/6
|
16.7%
1/6
|
16.7%
2/12
|
16.7%
2/12
|
|
General disorders
Restlessness-1 hour post meal
|
14.3%
2/14
|
0.00%
0/14
|
0.00%
0/5
|
20.0%
1/5
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
2/12
|
8.3%
1/12
|
|
General disorders
Restlessness-prior to discharge
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/6
|
33.3%
1/3
|
0.00%
0/12
|
|
General disorders
Runny nose-during past week
|
0.00%
0/14
|
7.1%
1/14
|
20.0%
1/5
|
20.0%
1/5
|
16.7%
1/6
|
0.00%
0/6
|
16.7%
2/12
|
0.00%
0/12
|
|
General disorders
Runny nose-prior to injection
|
0.00%
0/14
|
0.00%
0/14
|
20.0%
1/5
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/12
|
|
General disorders
Runny nose-30 minutes post injection
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/12
|
0.00%
0/12
|
|
General disorders
Runny nose-end of clamp
|
0.00%
0/14
|
7.1%
1/14
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/12
|
0.00%
0/12
|
|
General disorders
Tremor-during past week
|
7.1%
1/14
|
7.1%
1/14
|
20.0%
1/5
|
20.0%
1/5
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/12
|
|
General disorders
Tremor-1 hour post meal
|
7.1%
1/14
|
7.1%
1/14
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/12
|
|
General disorders
Nausea-during past week
|
7.1%
1/14
|
0.00%
0/14
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/12
|
|
General disorders
Nausea-prior to injection
|
0.00%
0/14
|
7.1%
1/14
|
0.00%
0/5
|
0.00%
0/5
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/12
|
|
General disorders
Nausea-end of clamp
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/12
|
|
General disorders
Vomiting-during past week
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/12
|
|
General disorders
Weakness-30 minutes post injection
|
7.1%
1/14
|
0.00%
0/14
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/12
|
|
General disorders
Weakness-end of clamp
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/12
|
|
General disorders
Weakness-1 hour post meal
|
7.1%
1/14
|
0.00%
0/14
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/12
|
|
General disorders
Hungry-during past week
|
71.4%
10/14
|
85.7%
12/14
|
100.0%
5/5
|
80.0%
4/5
|
83.3%
5/6
|
83.3%
5/6
|
75.0%
9/12
|
66.7%
8/12
|
|
General disorders
Hungry-prior to injection
|
78.6%
11/14
|
78.6%
11/14
|
100.0%
5/5
|
100.0%
5/5
|
83.3%
5/6
|
80.0%
4/5
|
75.0%
9/12
|
66.7%
8/12
|
|
General disorders
Hungry-30 minutes post injection
|
71.4%
10/14
|
78.6%
11/14
|
100.0%
5/5
|
100.0%
5/5
|
100.0%
6/6
|
83.3%
5/6
|
83.3%
10/12
|
83.3%
10/12
|
|
General disorders
Hungry-end of clamp
|
57.1%
8/14
|
64.3%
9/14
|
80.0%
4/5
|
80.0%
4/5
|
83.3%
5/6
|
66.7%
4/6
|
58.3%
7/12
|
75.0%
9/12
|
|
General disorders
Hungry-1 hour post meal
|
0.00%
0/14
|
0.00%
0/14
|
20.0%
1/5
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/12
|
|
General disorders
Pain-during past week
|
14.3%
2/14
|
14.3%
2/14
|
0.00%
0/5
|
40.0%
2/5
|
0.00%
0/6
|
16.7%
1/6
|
8.3%
1/12
|
8.3%
1/12
|
|
General disorders
Pain-prior to injection
|
0.00%
0/14
|
28.6%
4/14
|
0.00%
0/5
|
0.00%
0/5
|
16.7%
1/6
|
16.7%
1/6
|
0.00%
0/12
|
16.7%
2/12
|
|
General disorders
Pain-30 minutes post injection
|
0.00%
0/14
|
21.4%
3/14
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/6
|
33.3%
2/6
|
8.3%
1/12
|
8.3%
1/12
|
|
General disorders
Pain-end of clamp
|
0.00%
0/14
|
14.3%
2/14
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/12
|
0.00%
0/12
|
|
General disorders
Pain-1 hour post meal
|
7.1%
1/14
|
14.3%
2/14
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/12
|
|
General disorders
Other-Neck uncomfortable (end of clamp)
|
7.1%
1/14
|
0.00%
0/14
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/12
|
|
General disorders
Other-Neck uncomfortable (1 hour post meal)
|
7.1%
1/14
|
0.00%
0/14
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/12
|
|
General disorders
Dizziness-end of clamp
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/5
|
20.0%
1/5
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/12
|
Additional Information
Julie Schweiger/Michael Yingling
Washington University
Phone: 3143623153/5735791412
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place