Trial Outcomes & Findings for Effects of Metformin During Nicotine Withdrawal (NCT NCT03593538)
NCT ID: NCT03593538
Last Updated: 2021-03-26
Results Overview
Self-reported mood on the Positive and Negative Affect Schedule (PANAS), a 20-item Likert-format measure that assesses Positive Affect (PA; 10 items, e.g., enthusiastic, strong) and Negative Affect (NA; 10 items, e.g., distressed, upset). The minimum value for each subscale is 10 and the maximum value is 50. Higher scores indicate greater positive or negative affect.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
80 participants
Primary outcome timeframe
Day 23
Results posted on
2021-03-26
Participant Flow
Of the 80 subjects, who signed consent and were deemed eligible to participate, 11 did not attend the Baseline session during which they would begin treatment leaving 69 subjects who started study medication.
Participant milestones
| Measure |
Low Dose Metformin
Days 1-7: Metformin 500 mg per day; Days 8-14: Metformin 500 mg and 1 Placebo capsule per day; Days 15-23: Metformin 500 mg and 2 Placebo capsules per day
Metformin: Metformin capsule
Placebo: Sucrose filler in gel capsules
|
High Dose Metformin
Days 1-7: Metformin 500 mg per day; Days 8-14: Metformin 1000 mg per day; Days 15-23: Metformin 1500 mg per day
Metformin: Metformin capsule
|
Placebo
Days 1-7: 1 Placebo capsule per day; Days 8-14: 2 Placebo capsules per day; Days 15-23: 3 Placebo capsules per day
Placebo: Sucrose filler in gel capsules
|
|---|---|---|---|
|
Overall Study
STARTED
|
26
|
21
|
22
|
|
Overall Study
COMPLETED
|
15
|
15
|
11
|
|
Overall Study
NOT COMPLETED
|
11
|
6
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of Metformin During Nicotine Withdrawal
Baseline characteristics by cohort
| Measure |
Low Dose Metformin
n=26 Participants
Days 1-7: Metformin 500 mg per day; Days 8-14: Metformin 500 mg and 1 Placebo capsule per day; Days 15-23: Metformin 500 mg and 2 Placebo capsules per day
Metformin: Metformin capsule
Placebo: Sucrose filler in gel capsules
|
High Dose Metformin
n=21 Participants
Days 1-7: Metformin 500 mg per day; Days 8-14: Metformin 1000 mg per day; Days 15-23: Metformin 1500 mg per day
Metformin: Metformin capsule
|
Placebo
n=22 Participants
Days 1-7: 1 Placebo capsule per day; Days 8-14: 2 Placebo capsules per day; Days 15-23: 3 Placebo capsules per day
Placebo: Sucrose filler in gel capsules
|
Total
n=69 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
49.8 years
n=5 Participants
|
43.1 years
n=7 Participants
|
50.5 years
n=5 Participants
|
47.9 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
64 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 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
|
|
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
|
|
Race (NIH/OMB)
Black or African American
|
18 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
52 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
26 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
69 Participants
n=4 Participants
|
|
Cigarettes per day
|
12.6 cigarettes per day
n=5 Participants
|
12.6 cigarettes per day
n=7 Participants
|
16 cigarettes per day
n=5 Participants
|
13.7 cigarettes per day
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 23Population: Study Completers
Self-reported mood on the Positive and Negative Affect Schedule (PANAS), a 20-item Likert-format measure that assesses Positive Affect (PA; 10 items, e.g., enthusiastic, strong) and Negative Affect (NA; 10 items, e.g., distressed, upset). The minimum value for each subscale is 10 and the maximum value is 50. Higher scores indicate greater positive or negative affect.
Outcome measures
| Measure |
Low Dose Metformin
n=15 Participants
Days 1-7: Metformin 500 mg per day; Days 8-14: Metformin 500 mg and 1 Placebo capsule per day; Days 15-23: Metformin 500 mg and 2 Placebo capsules per day
Metformin: Metformin capsule
Placebo: Sucrose filler in gel capsules
|
High Dose Metformin
n=15 Participants
Days 1-7: Metformin 500 mg per day; Days 8-14: Metformin 1000 mg per day; Days 15-23: Metformin 1500 mg per day
Metformin: Metformin capsule
|
Placebo
n=11 Participants
Days 1-7: 1 Placebo capsule per day; Days 8-14: 2 Placebo capsules per day; Days 15-23: 3 Placebo capsules per day
Placebo: Sucrose filler in gel capsules
|
|---|---|---|---|
|
Mood Following 24h of Smoking Abstinence
Positive Affect
|
36.5 score on a scale
Standard Error 2.5
|
33.8 score on a scale
Standard Error 2.8
|
37.9 score on a scale
Standard Error 2.6
|
|
Mood Following 24h of Smoking Abstinence
Negative Affect
|
14.3 score on a scale
Standard Error 1.3
|
13.1 score on a scale
Standard Error 0.9
|
13.9 score on a scale
Standard Error 1.8
|
PRIMARY outcome
Timeframe: Day 23Population: Study Completers
Composite score of computer-based neurocognitive tasks (N-back Working Memory Task, Stop Signal Task, Hopkins Verbal Learning Test - Revised \[HVLT-R\]) designed to test working memory and attention. A standardized z-score (mean=0, standard deviation=1) was calculated for the primary outcome for each task and an average was computed from the three z-scores. Higher scores indicated better cognitive performance.
Outcome measures
| Measure |
Low Dose Metformin
n=15 Participants
Days 1-7: Metformin 500 mg per day; Days 8-14: Metformin 500 mg and 1 Placebo capsule per day; Days 15-23: Metformin 500 mg and 2 Placebo capsules per day
Metformin: Metformin capsule
Placebo: Sucrose filler in gel capsules
|
High Dose Metformin
n=15 Participants
Days 1-7: Metformin 500 mg per day; Days 8-14: Metformin 1000 mg per day; Days 15-23: Metformin 1500 mg per day
Metformin: Metformin capsule
|
Placebo
n=11 Participants
Days 1-7: 1 Placebo capsule per day; Days 8-14: 2 Placebo capsules per day; Days 15-23: 3 Placebo capsules per day
Placebo: Sucrose filler in gel capsules
|
|---|---|---|---|
|
Cognitive Function Following 24h of Smoking Abstinence
|
-0.018 z-score
Standard Error 0.17
|
0.159 z-score
Standard Error 0.22
|
-0.204 z-score
Standard Error 0.29
|
SECONDARY outcome
Timeframe: Days 7, 14, 21, and 23Population: Study Completers
Cigarettes smoked per day as reported on the Timeline Follow-Back (TLFB). Cigarettes smoked per day is assessed using a "past week" time reference for all time points except the 24-hr testing visit on Day 23, which uses a 24-hr time reference.
Outcome measures
| Measure |
Low Dose Metformin
n=15 Participants
Days 1-7: Metformin 500 mg per day; Days 8-14: Metformin 500 mg and 1 Placebo capsule per day; Days 15-23: Metformin 500 mg and 2 Placebo capsules per day
Metformin: Metformin capsule
Placebo: Sucrose filler in gel capsules
|
High Dose Metformin
n=15 Participants
Days 1-7: Metformin 500 mg per day; Days 8-14: Metformin 1000 mg per day; Days 15-23: Metformin 1500 mg per day
Metformin: Metformin capsule
|
Placebo
n=11 Participants
Days 1-7: 1 Placebo capsule per day; Days 8-14: 2 Placebo capsules per day; Days 15-23: 3 Placebo capsules per day
Placebo: Sucrose filler in gel capsules
|
|---|---|---|---|
|
Self-reported Smoking Behavior
Day 7
|
13.9 cigarettes per day
Standard Error 2.2
|
8 cigarettes per day
Standard Error 1.1
|
11.2 cigarettes per day
Standard Error 1.8
|
|
Self-reported Smoking Behavior
Day 14
|
11.8 cigarettes per day
Standard Error 1.8
|
8.1 cigarettes per day
Standard Error 1.0
|
10.4 cigarettes per day
Standard Error 1.8
|
|
Self-reported Smoking Behavior
Day 21
|
12.5 cigarettes per day
Standard Error 1.7
|
7.4 cigarettes per day
Standard Error 0.9
|
10.1 cigarettes per day
Standard Error 1.2
|
|
Self-reported Smoking Behavior
Day 23
|
0 cigarettes per day
Standard Error 0
|
0 cigarettes per day
Standard Error 0
|
0 cigarettes per day
Standard Error 0
|
SECONDARY outcome
Timeframe: Days 7, 14, 21, and 23Population: Study Completers
The "Minnesota Nicotine Withdrawal Scale - Revised version"(MNWS\_R) captures the current state of nicotine withdrawal. The scale assesses eight DSM-IV items of nicotine withdrawal including: dysphoria or depressed mood, insomnia, irritability/frustration/anger, anxiety, decreased heart rate, difficulty concentrating, restlessness, and increased appetite/weight gain. Participants rate the intensity of their symptoms on the following scale: 0 = none, 1 = slight, 2 = mild, 3 = moderate, 4 = severe and a summary score will be calculated. Withdrawal is assessed using a "past week" time reference for all time points except the 24-hr testing visit on Day 23, which uses a 24-hr time reference. The scale ranges from 0 to 32 with higher scores indicating more severe withdrawal symptoms.
Outcome measures
| Measure |
Low Dose Metformin
n=15 Participants
Days 1-7: Metformin 500 mg per day; Days 8-14: Metformin 500 mg and 1 Placebo capsule per day; Days 15-23: Metformin 500 mg and 2 Placebo capsules per day
Metformin: Metformin capsule
Placebo: Sucrose filler in gel capsules
|
High Dose Metformin
n=15 Participants
Days 1-7: Metformin 500 mg per day; Days 8-14: Metformin 1000 mg per day; Days 15-23: Metformin 1500 mg per day
Metformin: Metformin capsule
|
Placebo
n=11 Participants
Days 1-7: 1 Placebo capsule per day; Days 8-14: 2 Placebo capsules per day; Days 15-23: 3 Placebo capsules per day
Placebo: Sucrose filler in gel capsules
|
|---|---|---|---|
|
Self-reported Withdrawal Symptoms
Day 7
|
7.4 score on a scale
Standard Error 1.3
|
6.3 score on a scale
Standard Error 0.9
|
7.9 score on a scale
Standard Error 1.5
|
|
Self-reported Withdrawal Symptoms
Day 14
|
7.0 score on a scale
Standard Error 1.4
|
6.2 score on a scale
Standard Error 0.8
|
8.3 score on a scale
Standard Error 2.2
|
|
Self-reported Withdrawal Symptoms
Day 21
|
7.8 score on a scale
Standard Error 1.6
|
5.5 score on a scale
Standard Error 0.9
|
7.1 score on a scale
Standard Error 1.7
|
|
Self-reported Withdrawal Symptoms
Day 23
|
10.5 score on a scale
Standard Error 2.1
|
8.7 score on a scale
Standard Error 1.3
|
11.8 score on a scale
Standard Error 2.8
|
SECONDARY outcome
Timeframe: Days 7, 14, 21, and 23Population: Study Completers
The 10-item brief Questionnaire of Smoking Urges (QSU-B) assesses craving for cigarettes. The QSU-B contains 2 sub-scales (anticipation of reward, relief from negative affect) which are summed to create the total score. Similar to withdrawal symptoms, craving is assessed using a "past week" time reference for all time points except the 24-hr testing visit on Day 23, which will use a 24-hr time reference. Items are rated from 1 (strongly disagree) to 7 (strongly agree) and are summed to create a total score ranging from 10 to 70. Higher scores indicate higher levels of craving.
Outcome measures
| Measure |
Low Dose Metformin
n=15 Participants
Days 1-7: Metformin 500 mg per day; Days 8-14: Metformin 500 mg and 1 Placebo capsule per day; Days 15-23: Metformin 500 mg and 2 Placebo capsules per day
Metformin: Metformin capsule
Placebo: Sucrose filler in gel capsules
|
High Dose Metformin
n=15 Participants
Days 1-7: Metformin 500 mg per day; Days 8-14: Metformin 1000 mg per day; Days 15-23: Metformin 1500 mg per day
Metformin: Metformin capsule
|
Placebo
n=11 Participants
Days 1-7: 1 Placebo capsule per day; Days 8-14: 2 Placebo capsules per day; Days 15-23: 3 Placebo capsules per day
Placebo: Sucrose filler in gel capsules
|
|---|---|---|---|
|
Self-reported Craving for Cigarettes
Day 7
|
32.9 score on a scale
Standard Error 4.4
|
26.1 score on a scale
Standard Error 4.2
|
40.3 score on a scale
Standard Error 5.8
|
|
Self-reported Craving for Cigarettes
Day 14
|
31.2 score on a scale
Standard Error 3.6
|
22.3 score on a scale
Standard Error 3.8
|
38.4 score on a scale
Standard Error 5.9
|
|
Self-reported Craving for Cigarettes
Day 21
|
28.3 score on a scale
Standard Error 3.8
|
21.4 score on a scale
Standard Error 3.3
|
36.7 score on a scale
Standard Error 5.2
|
|
Self-reported Craving for Cigarettes
Day 23
|
45.2 score on a scale
Standard Error 5.0
|
39.9 score on a scale
Standard Error 4.4
|
52.9 score on a scale
Standard Error 3.8
|
SECONDARY outcome
Timeframe: Days 7, 14, 21, and 23Population: Study Completers
The Cigarette Evaluation Scale (CES), developed to assess subjective effects of smoking, is an 11-item Likert-format measure. Questions include items for nausea and dizziness, craving relief, and enjoyment of airway sensations and comprise 3 scales: satisfaction score, psychological relief score, and toxicity score. Each scale is the average of items with a minimum value of 1 and a maximum value of 7. Higher scores indicate more satisfaction, greater psychological relief, and higher subjective toxicity, respectively.
Outcome measures
| Measure |
Low Dose Metformin
n=15 Participants
Days 1-7: Metformin 500 mg per day; Days 8-14: Metformin 500 mg and 1 Placebo capsule per day; Days 15-23: Metformin 500 mg and 2 Placebo capsules per day
Metformin: Metformin capsule
Placebo: Sucrose filler in gel capsules
|
High Dose Metformin
n=15 Participants
Days 1-7: Metformin 500 mg per day; Days 8-14: Metformin 1000 mg per day; Days 15-23: Metformin 1500 mg per day
Metformin: Metformin capsule
|
Placebo
n=11 Participants
Days 1-7: 1 Placebo capsule per day; Days 8-14: 2 Placebo capsules per day; Days 15-23: 3 Placebo capsules per day
Placebo: Sucrose filler in gel capsules
|
|---|---|---|---|
|
Subjective Effects of Smoking
Satisfaction (Day 7)
|
4.7 score on a scale
Standard Error 0.4
|
3.8 score on a scale
Standard Error 0.4
|
5.8 score on a scale
Standard Error 0.4
|
|
Subjective Effects of Smoking
Satisfaction (Day 14)
|
5.0 score on a scale
Standard Error 0.4
|
3.4 score on a scale
Standard Error 0.5
|
5.2 score on a scale
Standard Error 0.4
|
|
Subjective Effects of Smoking
Satisfaction (Day 23)
|
5.1 score on a scale
Standard Error 0.5
|
3.6 score on a scale
Standard Error 0.6
|
4.9 score on a scale
Standard Error 0.6
|
|
Subjective Effects of Smoking
Psychological Relief (Day 21)
|
2.8 score on a scale
Standard Error 0.5
|
1.9 score on a scale
Standard Error 0.3
|
3.9 score on a scale
Standard Error 0.6
|
|
Subjective Effects of Smoking
Toxicity (Day 7)
|
1.1 score on a scale
Standard Error 0.06
|
1.4 score on a scale
Standard Error 0.18
|
1.3 score on a scale
Standard Error 0.15
|
|
Subjective Effects of Smoking
Toxicity (Day 14)
|
1.1 score on a scale
Standard Error .08
|
1.6 score on a scale
Standard Error 0.30
|
1.3 score on a scale
Standard Error .15
|
|
Subjective Effects of Smoking
Toxicity (Day 21)
|
1.3 score on a scale
Standard Error 0.11
|
1.2 score on a scale
Standard Error 0.11
|
1.3 score on a scale
Standard Error 0.16
|
|
Subjective Effects of Smoking
Toxicity (Day 23)
|
2.1 score on a scale
Standard Error 0.26
|
2.1 score on a scale
Standard Error 0.26
|
2.6 score on a scale
Standard Error 0.45
|
|
Subjective Effects of Smoking
Satisfaction (Day 21)
|
4.5 score on a scale
Standard Error 0.4
|
3.6 score on a scale
Standard Error 0.4
|
5.0 score on a scale
Standard Error 0.4
|
|
Subjective Effects of Smoking
Psychological Relief (Day 7)
|
2.7 score on a scale
Standard Error 0.4
|
2.0 score on a scale
Standard Error 0.2
|
4.0 score on a scale
Standard Error 0.6
|
|
Subjective Effects of Smoking
Psychological Relief (Day 14)
|
3.0 score on a scale
Standard Error 0.5
|
2.0 score on a scale
Standard Error 0.3
|
3.5 score on a scale
Standard Error 0.5
|
|
Subjective Effects of Smoking
Psychological Relief (Day 23)
|
3.2 score on a scale
Standard Error 0.4
|
2.1 score on a scale
Standard Error 0.3
|
3.6 score on a scale
Standard Error 0.5
|
SECONDARY outcome
Timeframe: Days 7, 14, 21, and 23Population: Study Completers
The Rose Sensory Questionnaire (SQ), a 9-item Likert-format measure, assesses how much participants liked the cigarette smoked (liking scale) and how high in nicotine the cigarettes appeared to be (strength scale). The questionnaire also includes a diagram of the respiratory tract and asks participants to rate the strength of the cigarette puffs on their tongue, nose, back of mouth and throat, windpipe, and chest. Each scale is the average of items with a minimum value of 1 and a maximum value of 7. Higher scores indicate greater liking and perceived strength, respectively.
Outcome measures
| Measure |
Low Dose Metformin
n=15 Participants
Days 1-7: Metformin 500 mg per day; Days 8-14: Metformin 500 mg and 1 Placebo capsule per day; Days 15-23: Metformin 500 mg and 2 Placebo capsules per day
Metformin: Metformin capsule
Placebo: Sucrose filler in gel capsules
|
High Dose Metformin
n=15 Participants
Days 1-7: Metformin 500 mg per day; Days 8-14: Metformin 1000 mg per day; Days 15-23: Metformin 1500 mg per day
Metformin: Metformin capsule
|
Placebo
n=11 Participants
Days 1-7: 1 Placebo capsule per day; Days 8-14: 2 Placebo capsules per day; Days 15-23: 3 Placebo capsules per day
Placebo: Sucrose filler in gel capsules
|
|---|---|---|---|
|
Subjective Sensory Experience of Smoking
Liking scale (Day 7)
|
4.6 score on a scale
Standard Error 0.33
|
3.8 score on a scale
Standard Error 0.36
|
5.0 score on a scale
Standard Error 0.33
|
|
Subjective Sensory Experience of Smoking
Liking scale (Day 14)
|
4.6 score on a scale
Standard Error 0.29
|
3.6 score on a scale
Standard Error 0.44
|
4.8 score on a scale
Standard Error 0.43
|
|
Subjective Sensory Experience of Smoking
Liking scale (Day 21)
|
4.4 score on a scale
Standard Error 0.37
|
3.6 score on a scale
Standard Error 0.43
|
4.7 score on a scale
Standard Error 0.29
|
|
Subjective Sensory Experience of Smoking
Liking scale (Day 23)
|
4.7 score on a scale
Standard Error 0.36
|
3.7 score on a scale
Standard Error 0.43
|
4.8 score on a scale
Standard Error 0.48
|
|
Subjective Sensory Experience of Smoking
Strength scale (Day 7)
|
3.9 score on a scale
Standard Error 0.34
|
3.4 score on a scale
Standard Error 0.45
|
3.9 score on a scale
Standard Error 0.42
|
|
Subjective Sensory Experience of Smoking
Strength scale (Day 14)
|
4.0 score on a scale
Standard Error 0.39
|
2.9 score on a scale
Standard Error 0.47
|
3.9 score on a scale
Standard Error 0.39
|
|
Subjective Sensory Experience of Smoking
Strength scale (Day 23)
|
4.1 score on a scale
Standard Error 0.40
|
3.4 score on a scale
Standard Error 0.51
|
4.0 score on a scale
Standard Error 0.47
|
|
Subjective Sensory Experience of Smoking
Strength scale (Day 21)
|
3.5 score on a scale
Standard Error 0.43
|
2.9 score on a scale
Standard Error 0.44
|
3.5 score on a scale
Standard Error 0.29
|
Adverse Events
Low Dose Metformin
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
High Dose Metformin
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Low Dose Metformin
n=26 participants at risk
Days 1-7: Metformin 500 mg per day; Days 8-14: Metformin 500 mg and 1 Placebo capsule per day; Days 15-23: Metformin 500 mg and 2 Placebo capsules per day
Metformin: Metformin capsule
Placebo: Sucrose filler in gel capsules
|
High Dose Metformin
n=21 participants at risk
Days 1-7: Metformin 500 mg per day; Days 8-14: Metformin 1000 mg per day; Days 15-23: Metformin 1500 mg per day
Metformin: Metformin capsule
|
Placebo
n=22 participants at risk
Days 1-7: 1 Placebo capsule per day; Days 8-14: 2 Placebo capsules per day; Days 15-23: 3 Placebo capsules per day
Placebo: Sucrose filler in gel capsules
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
3.8%
1/26 • Through study completion, an average of 30 days
|
0.00%
0/21 • Through study completion, an average of 30 days
|
0.00%
0/22 • Through study completion, an average of 30 days
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/26 • Through study completion, an average of 30 days
|
4.8%
1/21 • Through study completion, an average of 30 days
|
4.5%
1/22 • Through study completion, an average of 30 days
|
|
Gastrointestinal disorders
Diarrhea
|
3.8%
1/26 • Through study completion, an average of 30 days
|
0.00%
0/21 • Through study completion, an average of 30 days
|
4.5%
1/22 • Through study completion, an average of 30 days
|
|
General disorders
Headache
|
3.8%
1/26 • Through study completion, an average of 30 days
|
4.8%
1/21 • Through study completion, an average of 30 days
|
13.6%
3/22 • Through study completion, an average of 30 days
|
|
Gastrointestinal disorders
Heartburn
|
0.00%
0/26 • Through study completion, an average of 30 days
|
0.00%
0/21 • Through study completion, an average of 30 days
|
4.5%
1/22 • Through study completion, an average of 30 days
|
|
Vascular disorders
Hypertension
|
23.1%
6/26 • Through study completion, an average of 30 days
|
33.3%
7/21 • Through study completion, an average of 30 days
|
22.7%
5/22 • Through study completion, an average of 30 days
|
|
General disorders
Increased Sweating
|
3.8%
1/26 • Through study completion, an average of 30 days
|
4.8%
1/21 • Through study completion, an average of 30 days
|
4.5%
1/22 • Through study completion, an average of 30 days
|
|
General disorders
Minor Head Injury
|
3.8%
1/26 • Through study completion, an average of 30 days
|
0.00%
0/21 • Through study completion, an average of 30 days
|
0.00%
0/22 • Through study completion, an average of 30 days
|
|
General disorders
Mouth Sores
|
0.00%
0/26 • Through study completion, an average of 30 days
|
0.00%
0/21 • Through study completion, an average of 30 days
|
4.5%
1/22 • Through study completion, an average of 30 days
|
|
Gastrointestinal disorders
Nausea
|
3.8%
1/26 • Through study completion, an average of 30 days
|
4.8%
1/21 • Through study completion, an average of 30 days
|
0.00%
0/22 • Through study completion, an average of 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Infection
|
0.00%
0/26 • Through study completion, an average of 30 days
|
0.00%
0/21 • Through study completion, an average of 30 days
|
4.5%
1/22 • Through study completion, an average of 30 days
|
Additional Information
Dr. Rebecca Ashare
Perelman School of Medicine at the University of Pennsylvania
Phone: 2157465789
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place