Trial Outcomes & Findings for Safety & Tolerability of a Combination of Antidepressant and Peptic Ulcer Drug in Overweight Healthy Subjects (NCT NCT01155531)
NCT ID: NCT01155531
Last Updated: 2019-06-17
Results Overview
The baseline VAS self-assessment was completed for each subject on day 7 of each dose combination. Appetite VAS was completed in the subject's room approximately 30 min before and 1 h after each meal serving. Appetite was not assessed prior to snacks. VAS assessment was based on response to the question: "How hungry are you now?" The anchor points of the 100mm scale were "I am not hungry at all" and "Never more hungry" corresponding to 0 mm and 100 mm respectively. The subjects' VAS scores were measured by the clinic staff and entered into the CRF. The description listed below (VAS after meal minus and VAS before meal) refers only to the mean VAS score of each group.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
40 participants
Primary outcome timeframe
The baseline was defined on day 7 of sertraline treatment with no telenzepine before and meal. Appetite VAS was measured 30 min before and 1hour after to meal
Results posted on
2019-06-17
Participant Flow
Participant milestones
| Measure |
Telenzepine - Group A
received Sertraline 0 mg/day for 7 days.After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
|
Telenzepine Plus Sertraline - Group B
received Sertraline 50 mg/day for 7 days. After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
|
Telenzepine Plus Sertraline - Group C
received Sertraline 100 mg/day for 7 days. After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
|
Telenzepine Plus Sertraline - Group D
received Sertraline 150 mg/day for 7 days. After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
10
|
10
|
|
Overall Study
COMPLETED
|
9
|
10
|
8
|
9
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
2
|
1
|
Reasons for withdrawal
| Measure |
Telenzepine - Group A
received Sertraline 0 mg/day for 7 days.After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
|
Telenzepine Plus Sertraline - Group B
received Sertraline 50 mg/day for 7 days. After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
|
Telenzepine Plus Sertraline - Group C
received Sertraline 100 mg/day for 7 days. After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
|
Telenzepine Plus Sertraline - Group D
received Sertraline 150 mg/day for 7 days. After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
1
|
0
|
Baseline Characteristics
Safety & Tolerability of a Combination of Antidepressant and Peptic Ulcer Drug in Overweight Healthy Subjects
Baseline characteristics by cohort
| Measure |
Telenzepine - Group A
n=10 Participants
received Sertraline 0 mg/day for 7 days.After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
|
Telenzepine Plus Sertraline - Group B
n=10 Participants
received Sertraline 50 mg/day for 7 days. After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
|
Telenzepine Plus Sertraline - Group C
n=10 Participants
received Sertraline 100 mg/day for 7 days. After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
|
Telenzepine Plus Sertraline - Group D
n=10 Participants
received Sertraline 150 mg/day for 7 days. After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
30.7 years
n=5 Participants
|
35.2 years
n=7 Participants
|
33.5 years
n=5 Participants
|
34.3 years
n=4 Participants
|
33.4 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
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
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
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
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
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
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
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
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
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
|
PRIMARY outcome
Timeframe: The baseline was defined on day 7 of sertraline treatment with no telenzepine before and meal. Appetite VAS was measured 30 min before and 1hour after to mealThe baseline VAS self-assessment was completed for each subject on day 7 of each dose combination. Appetite VAS was completed in the subject's room approximately 30 min before and 1 h after each meal serving. Appetite was not assessed prior to snacks. VAS assessment was based on response to the question: "How hungry are you now?" The anchor points of the 100mm scale were "I am not hungry at all" and "Never more hungry" corresponding to 0 mm and 100 mm respectively. The subjects' VAS scores were measured by the clinic staff and entered into the CRF. The description listed below (VAS after meal minus and VAS before meal) refers only to the mean VAS score of each group.
Outcome measures
| Measure |
Telenzepine - Group A
n=10 Participants
received Sertraline 0 mg/day for 7 days.After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
|
Telenzepine Plus Sertraline - Group B
n=10 Participants
received Sertraline 50 mg/day for 7 days.After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
|
Sertraline Plus Telenzepine - Group C
n=10 Participants
received Sertraline 100 mg/day for 7 days.After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
|
Sertraline Plus Telenzepine - Group D
n=10 Participants
received Sertraline 150 mg/day for 7 days.After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
|
|---|---|---|---|---|
|
Changes in the VAS Score From Baseline.
1 mg of Telenzepine (30 min before breakfast)
|
2.90 mm
Standard Deviation 28.77
|
2.70 mm
Standard Deviation 33.05
|
-10.8 mm
Standard Deviation 25.72
|
6.70 mm
Standard Deviation 22.98
|
|
Changes in the VAS Score From Baseline.
2 mg of Telenzepine (30 min before breakfast)
|
5.50 mm
Standard Deviation 34.58
|
-4.40 mm
Standard Deviation 24.80
|
18.50 mm
Standard Deviation 29.38
|
-4.5 mm
Standard Deviation 32.74
|
|
Changes in the VAS Score From Baseline.
3 mg of Telenzepine (30 min before breakfast)
|
12.22 mm
Standard Deviation 34.66
|
-7.60 mm
Standard Deviation 25.16
|
14.33 mm
Standard Deviation 31.86
|
-4.60 mm
Standard Deviation 30.89
|
|
Changes in the VAS Score From Baseline.
1 mg of Telenzepine (1 hour after breakfast)
|
5.50 mm
Standard Deviation 16.64
|
-2.40 mm
Standard Deviation 4.84
|
-9.60 mm
Standard Deviation 40.56
|
1.20 mm
Standard Deviation 16.62
|
|
Changes in the VAS Score From Baseline.
2 mg of Telenzepine (1 hour after breakfast)
|
2.30 mm
Standard Deviation 8.18
|
-5.20 mm
Standard Deviation 8.35
|
0.1 mm
Standard Deviation 20.90
|
6.70 mm
Standard Deviation 23.68
|
|
Changes in the VAS Score From Baseline.
3 mg of Telenzepine (1 hour after breakfast)
|
4.11 mm
Standard Deviation 13.01
|
-7.60 mm
Standard Deviation 8.90
|
-2.89 mm
Standard Deviation 31.85
|
3.50 mm
Standard Deviation 23.63
|
|
Changes in the VAS Score From Baseline.
1 mg of Telenzepine (30 min before lunch)
|
1.60 mm
Standard Deviation 18.76
|
-14.50 mm
Standard Deviation 17.97
|
-2.10 mm
Standard Deviation 26.21
|
4.60 mm
Standard Deviation 31.37
|
|
Changes in the VAS Score From Baseline.
2 mg of Telenzepine (30 min before lunch)
|
-8.60 mm
Standard Deviation 23.32
|
-16.30 mm
Standard Deviation 18.85
|
9.60 mm
Standard Deviation 24.47
|
2.40 mm
Standard Deviation 27.59
|
|
Changes in the VAS Score From Baseline.
3 mg of Telenzepine (30 min before lunch)
|
-16.78 mm
Standard Deviation 25.37
|
-23.40 mm
Standard Deviation 25.91
|
0.44 mm
Standard Deviation 21.90
|
-2.70 mm
Standard Deviation 19.81
|
|
Changes in the VAS Score From Baseline.
1 mg of Telenzepine (1 hour after lunch)
|
-2 mm
Standard Deviation 15.22
|
-3.90 mm
Standard Deviation 15
|
4.60 mm
Standard Deviation 17.16
|
11 mm
Standard Deviation 23.32
|
|
Changes in the VAS Score From Baseline.
2 mg of Telenzepine (1 hour after lunch)
|
-1.1 mm
Standard Deviation 12.34
|
-6.10 mm
Standard Deviation 9.21
|
5.70 mm
Standard Deviation 7.90
|
2 mm
Standard Deviation 6.77
|
|
Changes in the VAS Score From Baseline.
3 mg of Telenzepine (1 hour after lunch)
|
0.44 mm
Standard Deviation 8.95
|
-4.60 mm
Standard Deviation 8.91
|
12.11 mm
Standard Deviation 27.78
|
5.60 mm
Standard Deviation 22.37
|
|
Changes in the VAS Score From Baseline.
1 mg of Telenzepine (30 min before supper)
|
-4.10 mm
Standard Deviation 30.35
|
-1.20 mm
Standard Deviation 21.87
|
9.90 mm
Standard Deviation 26.41
|
12.50 mm
Standard Deviation 17.18
|
|
Changes in the VAS Score From Baseline.
2 mg of Telenzepine (30 min before supper)
|
-14.10 mm
Standard Deviation 19.55
|
-10.60 mm
Standard Deviation 17.05
|
4.50 mm
Standard Deviation 26.73
|
12.60 mm
Standard Deviation 21.61
|
|
Changes in the VAS Score From Baseline.
3 mg of Telenzepine (30 min before supper)
|
-20.67 mm
Standard Deviation 37.51
|
-17 mm
Standard Deviation 23.05
|
-13.33 mm
Standard Deviation 30.64
|
-1 mm
Standard Deviation 12.46
|
|
Changes in the VAS Score From Baseline.
1 mg of Telenzepine (1 hour after supper)
|
1.70 mm
Standard Deviation 7.57
|
-3.10 mm
Standard Deviation 16.39
|
-17 mm
Standard Deviation 8.38
|
13.70 mm
Standard Deviation 19.15
|
|
Changes in the VAS Score From Baseline.
2 mg of Telenzepine (1 hour after supper)
|
1.10 mm
Standard Deviation 7.78
|
-3.30 mm
Standard Deviation 15.58
|
-7 mm
Standard Deviation 17.33
|
-3.30 mm
Standard Deviation 26.19
|
|
Changes in the VAS Score From Baseline.
3 mg of Telenzepine (1 hour after supper)
|
-0.78 mm
Standard Deviation 3.93
|
-4.30 mm
Standard Deviation 14.44
|
-6.33 mm
Standard Deviation 16.65
|
-8.10 mm
Standard Deviation 26.44
|
PRIMARY outcome
Timeframe: The baseline was defined as on day 7 of sertraline treatment with no telenzepine. Food consumption was measured as calories consumed for breakfast, lunch, and dinner for all treatment groups on day 7 of each dose combination.The changes in the meal calories consumed was measured upon telenzepine treatment at the dose of 1 mg, 2 mg and 3 mg (i.e. end of every 7 days). The baseline was defined as on day 7 of sertraline treatment with no telenzepine for the specified meal. Food consumption was measured as calories consumed for breakfast, lunch, and dinner for all treatment groups on day 7 of each dose combination.
Outcome measures
| Measure |
Telenzepine - Group A
n=10 Participants
received Sertraline 0 mg/day for 7 days.After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
|
Telenzepine Plus Sertraline - Group B
n=10 Participants
received Sertraline 50 mg/day for 7 days.After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
|
Sertraline Plus Telenzepine - Group C
n=10 Participants
received Sertraline 100 mg/day for 7 days.After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
|
Sertraline Plus Telenzepine - Group D
n=10 Participants
received Sertraline 150 mg/day for 7 days.After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
|
|---|---|---|---|---|
|
Changes in the Meal Calories Consumed
3 mg telenzepine (lunch)
|
-22.36 calorie
Standard Deviation 171.6
|
-119.01 calorie
Standard Deviation 173.82
|
2.92 calorie
Standard Deviation 110.29
|
-4.94 calorie
Standard Deviation 153.37
|
|
Changes in the Meal Calories Consumed
3 mg telenzepine (supper)
|
9.26 calorie
Standard Deviation 140.61
|
61.88 calorie
Standard Deviation 107.28
|
-22.98 calorie
Standard Deviation 183.93
|
42.85 calorie
Standard Deviation 107.91
|
|
Changes in the Meal Calories Consumed
1 mg telenzepine (supper)
|
-19.92 calorie
Standard Deviation 110.88
|
47.66 calorie
Standard Deviation 62.55
|
87.01 calorie
Standard Deviation 171.07
|
-79.49 calorie
Standard Deviation 126.90
|
|
Changes in the Meal Calories Consumed
2 mg telenzepine (supper)
|
-26.16 calorie
Standard Deviation 129.51
|
-20.85 calorie
Standard Deviation 139.59
|
-13.10 calorie
Standard Deviation 182.34
|
-12.21 calorie
Standard Deviation 152.92
|
|
Changes in the Meal Calories Consumed
1 mg telenzepine (breakfast)
|
-63.70 calorie
Standard Deviation 76.50
|
-42.32 calorie
Standard Deviation 144.91
|
-88.93 calorie
Standard Deviation 99.56
|
-53.91 calorie
Standard Deviation 125.23
|
|
Changes in the Meal Calories Consumed
2 mg telenzepine (breakfast)
|
36.32 calorie
Standard Deviation 82.34
|
23.70 calorie
Standard Deviation 133.16
|
-2.32 calorie
Standard Deviation 78.06
|
-67.36 calorie
Standard Deviation 147.20
|
|
Changes in the Meal Calories Consumed
3 mg telenzepine (breakfast)
|
58.59 calorie
Standard Deviation 119.04
|
80.21 calorie
Standard Deviation 170.09
|
68.21 calorie
Standard Deviation 107.49
|
-28.81 calorie
Standard Deviation 144.40
|
|
Changes in the Meal Calories Consumed
1 mg telenzepine (lunch)
|
13.98 calorie
Standard Deviation 75.12
|
14.32 calorie
Standard Deviation 66
|
59.69 calorie
Standard Deviation 107.11
|
60.92 calorie
Standard Deviation 91.62
|
|
Changes in the Meal Calories Consumed
2 mg telenzepine (lunch)
|
33.91 calorie
Standard Deviation 91.76
|
58.39 calorie
Standard Deviation 129.87
|
144.50 calorie
Standard Deviation 131.55
|
12.09 calorie
Standard Deviation 111.57
|
PRIMARY outcome
Timeframe: 7 dayssafety of the drug combination was measured in terms of number of adverse events during the study period.
Outcome measures
| Measure |
Telenzepine - Group A
n=10 Participants
received Sertraline 0 mg/day for 7 days.After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
|
Telenzepine Plus Sertraline - Group B
n=10 Participants
received Sertraline 50 mg/day for 7 days.After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
|
Sertraline Plus Telenzepine - Group C
n=10 Participants
received Sertraline 100 mg/day for 7 days.After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
|
Sertraline Plus Telenzepine - Group D
n=10 Participants
received Sertraline 150 mg/day for 7 days.After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
|
|---|---|---|---|---|
|
Safety of Sertraline and Telenzepine Combination
Severe
|
0 number of adverse events
|
0 number of adverse events
|
1 number of adverse events
|
0 number of adverse events
|
|
Safety of Sertraline and Telenzepine Combination
Total
|
10 number of adverse events
|
17 number of adverse events
|
25 number of adverse events
|
47 number of adverse events
|
|
Safety of Sertraline and Telenzepine Combination
Mild
|
9 number of adverse events
|
15 number of adverse events
|
20 number of adverse events
|
43 number of adverse events
|
|
Safety of Sertraline and Telenzepine Combination
Moderate
|
1 number of adverse events
|
2 number of adverse events
|
4 number of adverse events
|
4 number of adverse events
|
Adverse Events
Telenzepine - Group A
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Telenzepine Plus Sertraline - Group B
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Telenzepine Plus Sertraline - Group C
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Telenzepine Plus Sertraline - Group D
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 |
Telenzepine - Group A
n=10 participants at risk
received Sertraline 0 mg/day for 7 days.After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
|
Telenzepine Plus Sertraline - Group B
n=10 participants at risk
received Sertraline 50 mg/day for 7 days. After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
|
Telenzepine Plus Sertraline - Group C
n=10 participants at risk
received Sertraline 100 mg/day for 7 days. After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
|
Telenzepine Plus Sertraline - Group D
n=10 participants at risk
received Sertraline 150 mg/day for 7 days. After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/10
|
0.00%
0/10
|
0.00%
0/10
|
10.0%
1/10 • Number of events 2
|
|
Nervous system disorders
Head ache
|
0.00%
0/10
|
50.0%
5/10 • Number of events 6
|
30.0%
3/10 • Number of events 3
|
60.0%
6/10 • Number of events 8
|
|
Gastrointestinal disorders
Diarrhea
|
20.0%
2/10 • Number of events 2
|
0.00%
0/10
|
0.00%
0/10
|
40.0%
4/10 • Number of events 5
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/10
|
20.0%
2/10 • Number of events 2
|
40.0%
4/10 • Number of events 4
|
40.0%
4/10 • Number of events 4
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/10
|
0.00%
0/10
|
0.00%
0/10
|
40.0%
4/10 • Number of events 5
|
|
Renal and urinary disorders
Increased urinary frequency
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
|
Psychiatric disorders
Insomnia
|
10.0%
1/10 • Number of events 1
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
|
Investigations
Elevated fasting glucose
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
0.00%
0/10
|
|
Gastrointestinal disorders
Abdominal pain
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
|
Gastrointestinal disorders
Vomitting
|
0.00%
0/10
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place