Trial Outcomes & Findings for Restoring Cognitive Control (ReCon) in Acute Nicotine Withdrawal (NCT NCT03887429)
NCT ID: NCT03887429
Last Updated: 2020-07-17
Results Overview
Endpoint assessed using the frequency of serious adverse events, adverse events leading to discontinuation, and adverse events judged to be related to study medication.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
34 participants
Primary outcome timeframe
Up to 5 days
Results posted on
2020-07-17
Participant Flow
Participant milestones
| Measure |
SXC-2023 200 mg Followed by Placebo
SXC-2023 200mg dosed once daily for 5 days, followed by 9 day washout, then Placebo dosed once daily for 5 days.
SXC-2023: SXC-2023 oral capsules
Placebos: Matching Placebo oral capsules
|
Placebo Followed by SXC-2023 200 mg
Placebo dosed once daily for 5 days, followed by 9 day washout, then SXC-2023 200mg dosed once daily for 5 days.
SXC-2023: SXC-2023 oral capsules
Placebos: Matching Placebo oral capsules
|
SXC-2023 800 mg Followed by Placebo
SXC-2023 800mg dosed once daily for 5 days, followed by 9 day washout, then Placebo dosed once daily for 5 days.
SXC-2023: SXC-2023 oral capsules
Placebos: Matching Placebo oral capsules
|
Placebo Followed by SXC-2023 800 mg
Placebo dosed once daily for 5 days, followed by 9 day washout, then SXC-2023 800mg dosed once daily for 5 days.
SXC-2023: SXC-2023 oral capsules
Placebos: Matching Placebo oral capsules
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
9
|
9
|
8
|
|
Overall Study
Completed First Intervention (5 Days)
|
7
|
8
|
7
|
7
|
|
Overall Study
Completed Washout (9 Days)
|
7
|
8
|
7
|
7
|
|
Overall Study
Completed Second Intervention (5 Days)
|
7
|
8
|
7
|
7
|
|
Overall Study
COMPLETED
|
7
|
8
|
7
|
7
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Restoring Cognitive Control (ReCon) in Acute Nicotine Withdrawal
Baseline characteristics by cohort
| Measure |
SXC-2023 200 mg Followed by Placebo
n=8 Participants
SXC-2023 200mg dosed once daily for 5 days, followed by 9 day washout, then Placebo dosed once daily for 5 days.
SXC-2023: SXC-2023 oral capsules
Placebos: Matching Placebo oral capsules
|
Placebo Followed by SXC-2023 200 mg
n=9 Participants
Placebo dosed once daily for 5 days, followed by 9 day washout, then SXC-2023 200mg dosed once daily for 5 days.
SXC-2023: SXC-2023 oral capsules
Placebos: Matching Placebo oral capsules
|
SXC-2023 800 mg Followed by Placebo
n=9 Participants
SXC-2023 800mg dosed once daily for 5 days, followed by 9 day washout, then Placebo dosed once daily for 5 days.
SXC-2023: SXC-2023 oral capsules
Placebos: Matching Placebo oral capsules
|
Placebo Followed by SXC-2023 800 mg
n=8 Participants
Placebo dosed once daily for 5 days, followed by 9 day washout, then SXC-2023 800mg dosed once daily for 5 days.
SXC-2023: SXC-2023 oral capsules
Placebos: Matching Placebo oral capsules
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Age, Categorical
<=18 years
|
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
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
34 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
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
|
|
Age, Continuous
|
45 years
STANDARD_DEVIATION 7.1 • n=5 Participants
|
44 years
STANDARD_DEVIATION 8.5 • n=7 Participants
|
39 years
STANDARD_DEVIATION 7.7 • n=5 Participants
|
41 years
STANDARD_DEVIATION 9.5 • n=4 Participants
|
42 years
STANDARD_DEVIATION 8.2 • n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
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
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
34 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
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
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)
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
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
9 participants
n=7 Participants
|
9 participants
n=5 Participants
|
8 participants
n=4 Participants
|
34 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Up to 5 daysEndpoint assessed using the frequency of serious adverse events, adverse events leading to discontinuation, and adverse events judged to be related to study medication.
Outcome measures
| Measure |
During 200 mg SXC-2023 Treatment
n=16 Participants
AEs observed during treatment with SXC-2023 200 mg.
|
During 800 mg SXC-2023 Treatment
n=16 Participants
AEs observed during treatment with SXC-2023 800 mg.
|
During Placebo Treatment
n=31 Participants
AEs observed during treatment with Placebo.
|
|---|---|---|---|
|
Safety and Tolerability of SXC-2023.
SAEs
|
0 Events
|
0 Events
|
0 Events
|
|
Safety and Tolerability of SXC-2023.
AEs leading to study discontinuation
|
0 Events
|
0 Events
|
0 Events
|
|
Safety and Tolerability of SXC-2023.
AEs judged to be related to study drug.
|
3 Events
|
1 Events
|
12 Events
|
PRIMARY outcome
Timeframe: 5 daysStop Signal Reaction Time (SSRT) assesses the length of reaction time between a 'go' stimulus and a 'stop' stimulus at which the subject is able to inhibit their motor response 50% of the time. The scale is from 0-1500 milliseconds with a lower value showing reduced motor impulsivity. Subject scores were collected pre-dose on day 1 of treatment and post-dose on day 5 of treatment, and the change in subject scores was assessed.
Outcome measures
| Measure |
During 200 mg SXC-2023 Treatment
n=9 Participants
AEs observed during treatment with SXC-2023 200 mg.
|
During 800 mg SXC-2023 Treatment
n=8 Participants
AEs observed during treatment with SXC-2023 800 mg.
|
During Placebo Treatment
n=17 Participants
AEs observed during treatment with Placebo.
|
|---|---|---|---|
|
Activity of SXC-2023 on Impulsivity, Measured Using Stop Signal Task.
|
4.6901 milliseconds
Standard Deviation 6.7368
|
-1.757 milliseconds
Standard Deviation 6.8491
|
3.956 milliseconds
Standard Deviation 3.9661
|
PRIMARY outcome
Timeframe: 5 daysCambridge Gamblers Task measures risk taking behavior using a score from -1 to 1, with a higher value showing increased impulsivity. Subject scores were collected pre-dose on day 1 of treatment and post-dose on day 5 of treatment and change in score assessed.
Outcome measures
| Measure |
During 200 mg SXC-2023 Treatment
n=9 Participants
AEs observed during treatment with SXC-2023 200 mg.
|
During 800 mg SXC-2023 Treatment
n=8 Participants
AEs observed during treatment with SXC-2023 800 mg.
|
During Placebo Treatment
n=17 Participants
AEs observed during treatment with Placebo.
|
|---|---|---|---|
|
Activity of SXC-2023 on Risk Taking Behavior, as Measured Using Cambridge Gamblers Task - Delay Aversion Total.
|
.03236 units on a scale
Standard Deviation .02652
|
.01358 units on a scale
Standard Deviation .02655
|
.03931 units on a scale
Standard Deviation .01569
|
PRIMARY outcome
Timeframe: Up to 5 days.Population: Subjects who did not complete treatment with both placebo and SXC-2023 were excluded from analysis.
Outcome to be measured using two scores ranging from 10-50, with a higher score indicating a more positive affect, and a lower score indicating a more negative affect. Subject scores were collected pre-dose on day 1 of treatment and post-dose on day 5 of treatment.
Outcome measures
| Measure |
During 200 mg SXC-2023 Treatment
n=14 Participants
AEs observed during treatment with SXC-2023 200 mg.
|
During 800 mg SXC-2023 Treatment
n=14 Participants
AEs observed during treatment with SXC-2023 800 mg.
|
During Placebo Treatment
AEs observed during treatment with Placebo.
|
|---|---|---|---|
|
Activity of SXC-2023 on Abstinence Induced Mood, Assessed by Positive and Negative Affect Schedule.
SXC-2023 Change in Negative Aspect
|
-.9 score on a scale
Standard Deviation 5.01
|
-1.2 score on a scale
Standard Deviation 2.61
|
—
|
|
Activity of SXC-2023 on Abstinence Induced Mood, Assessed by Positive and Negative Affect Schedule.
Placebo Change in Negative Aspect
|
-.7 score on a scale
Standard Deviation 3.93
|
.1 score on a scale
Standard Deviation 5.02
|
—
|
|
Activity of SXC-2023 on Abstinence Induced Mood, Assessed by Positive and Negative Affect Schedule.
SXC-2023 Change in Positive Aspect
|
3.5 score on a scale
Standard Deviation 8.2
|
2.1 score on a scale
Standard Deviation 7.0
|
—
|
|
Activity of SXC-2023 on Abstinence Induced Mood, Assessed by Positive and Negative Affect Schedule.
Placebo Change in Positive Aspect
|
2.0 score on a scale
Standard Deviation 7.43
|
3.3 score on a scale
Standard Deviation 6.5
|
—
|
PRIMARY outcome
Timeframe: Up to 5 days.Population: Subjects who did not complete treatment with both placebo and SXC-2023 were excluded from analysis.
Outcome to be measured using a score ranging from 10-70, with a higher score indicating a higher urge for a cigarette. Subject scores were collected pre-dose on day 1 of treatment and post-dose on day 5 of treatment.
Outcome measures
| Measure |
During 200 mg SXC-2023 Treatment
n=14 Participants
AEs observed during treatment with SXC-2023 200 mg.
|
During 800 mg SXC-2023 Treatment
n=14 Participants
AEs observed during treatment with SXC-2023 800 mg.
|
During Placebo Treatment
AEs observed during treatment with Placebo.
|
|---|---|---|---|
|
Activity of SXC-2023 on Measures of Abstinence Induced Urge for Cigarettes, Assessed by Questionnaire on Smoking Urges.
SXC-2023 Change in Anticipation of Pleasure
|
-.3 units on a scale
Standard Deviation 1.155
|
.64 units on a scale
Standard Deviation 1.332
|
—
|
|
Activity of SXC-2023 on Measures of Abstinence Induced Urge for Cigarettes, Assessed by Questionnaire on Smoking Urges.
Placebo change in Anticipation of Pleasure
|
-.04 units on a scale
Standard Deviation 1.1236
|
.17 units on a scale
Standard Deviation .848
|
—
|
|
Activity of SXC-2023 on Measures of Abstinence Induced Urge for Cigarettes, Assessed by Questionnaire on Smoking Urges.
SXC-2023 change in Anticipation of Relief
|
.14 units on a scale
Standard Deviation 1.201
|
.21 units on a scale
Standard Deviation 1.214
|
—
|
|
Activity of SXC-2023 on Measures of Abstinence Induced Urge for Cigarettes, Assessed by Questionnaire on Smoking Urges.
Placebo change in Anticipation of Relief
|
-.06 units on a scale
Standard Deviation .946
|
.46 units on a scale
Standard Deviation .794
|
—
|
PRIMARY outcome
Timeframe: Up to 5 days.Population: Complications with application of scales prevented collection of data from the majority of subjects.
Outcome to be measured using five scores ranging from 1-7 and corresponding to "Smoking Satisfaction," "Psychological Reward," "Aversion," "Enjoyment of Respiratory Tract Sensations" and "Craving Reduction." A higher score indicates a greater intensity of the associated sensation. Subject scores were collected pre-dose on day 1 of treatment and post-dose on day 5 of treatment.
Outcome measures
| Measure |
During 200 mg SXC-2023 Treatment
n=5 Participants
AEs observed during treatment with SXC-2023 200 mg.
|
During 800 mg SXC-2023 Treatment
n=4 Participants
AEs observed during treatment with SXC-2023 800 mg.
|
During Placebo Treatment
AEs observed during treatment with Placebo.
|
|---|---|---|---|
|
Activity of SXC-2023 on Measures of Abstinence Induced Urge for Cigarettes, Assessed by Cigarette Evaluation Questionnaire.
SXC-2023 change in Satisfaction
|
.1 units on a scale
Standard Deviation 1.28
|
.4 units on a scale
Standard Deviation .51
|
—
|
|
Activity of SXC-2023 on Measures of Abstinence Induced Urge for Cigarettes, Assessed by Cigarette Evaluation Questionnaire.
Placebo change in Satisfaction
|
.3 units on a scale
Standard Deviation .33
|
-.2 units on a scale
Standard Deviation .69
|
—
|
|
Activity of SXC-2023 on Measures of Abstinence Induced Urge for Cigarettes, Assessed by Cigarette Evaluation Questionnaire.
SXC-2023 change in Psychological reward
|
.16 units on a scale
Standard Deviation 1.315
|
.33 units on a scale
Standard Deviation .808
|
—
|
|
Activity of SXC-2023 on Measures of Abstinence Induced Urge for Cigarettes, Assessed by Cigarette Evaluation Questionnaire.
Placebo change in Psychological reward
|
.8 units on a scale
Standard Deviation .693
|
-.2 units on a scale
Standard Deviation 1.071
|
—
|
|
Activity of SXC-2023 on Measures of Abstinence Induced Urge for Cigarettes, Assessed by Cigarette Evaluation Questionnaire.
SXC-2023 change in Aversion
|
.7 units on a scale
Standard Deviation 1.396
|
0 units on a scale
Standard Deviation 0
|
—
|
|
Activity of SXC-2023 on Measures of Abstinence Induced Urge for Cigarettes, Assessed by Cigarette Evaluation Questionnaire.
Placebo change in Aversion
|
0 units on a scale
Standard Deviation 0
|
.63 units on a scale
Standard Deviation .946
|
—
|
|
Activity of SXC-2023 on Measures of Abstinence Induced Urge for Cigarettes, Assessed by Cigarette Evaluation Questionnaire.
SXC-2023 change in Enjoyment of Sensation
|
0 units on a scale
Standard Deviation 1.58
|
1.3 units on a scale
Standard Deviation 1.53
|
—
|
|
Activity of SXC-2023 on Measures of Abstinence Induced Urge for Cigarettes, Assessed by Cigarette Evaluation Questionnaire.
Placebo change in Enjoyment of Sensation
|
0 units on a scale
Standard Deviation 2
|
.8 units on a scale
Standard Deviation .96
|
—
|
|
Activity of SXC-2023 on Measures of Abstinence Induced Urge for Cigarettes, Assessed by Cigarette Evaluation Questionnaire.
SXC-2023 change in Craving Reduction
|
-.4 units on a scale
Standard Deviation 1.14
|
.3 units on a scale
Standard Deviation .58
|
—
|
|
Activity of SXC-2023 on Measures of Abstinence Induced Urge for Cigarettes, Assessed by Cigarette Evaluation Questionnaire.
Placebo change in Craving Reduction
|
-.7 units on a scale
Standard Deviation 2.08
|
0 units on a scale
Standard Deviation 1.41
|
—
|
PRIMARY outcome
Timeframe: Up to 5 days.Population: Subjects who did not complete treatment with both placebo and SXC-2023 were excluded from analysis.
Outcome to be measured using two scores, the first ranging from 10-70, with a higher score indicating a stronger urge to smoke, and the second score ranging from 10-80, with a higher score indicating a more positive mood. Subject scores were collected pre-dose on day 1 of treatment and post-dose on day 5 of treatment.
Outcome measures
| Measure |
During 200 mg SXC-2023 Treatment
n=14 Participants
AEs observed during treatment with SXC-2023 200 mg.
|
During 800 mg SXC-2023 Treatment
n=13 Participants
AEs observed during treatment with SXC-2023 800 mg.
|
During Placebo Treatment
AEs observed during treatment with Placebo.
|
|---|---|---|---|
|
Activity of SXC-2023 on Measures of Abstinence Induced Urge for Cigarettes and Mood, Assessed by Cue Reactivity and Likert Assessment.
SXC-2023 change in Neutral Urge
|
.353 units on a scale
Standard Deviation 1.7932
|
-.052 units on a scale
Standard Deviation 1.8934
|
—
|
|
Activity of SXC-2023 on Measures of Abstinence Induced Urge for Cigarettes and Mood, Assessed by Cue Reactivity and Likert Assessment.
Placebo change in Neutral Urge
|
-.142 units on a scale
Standard Deviation 1.5071
|
-.173 units on a scale
Standard Deviation 1.5458
|
—
|
|
Activity of SXC-2023 on Measures of Abstinence Induced Urge for Cigarettes and Mood, Assessed by Cue Reactivity and Likert Assessment.
SXC-2023 change in Neutral Mood
|
1.058 units on a scale
Standard Deviation 1.3775
|
1.667 units on a scale
Standard Deviation 1.6004
|
—
|
|
Activity of SXC-2023 on Measures of Abstinence Induced Urge for Cigarettes and Mood, Assessed by Cue Reactivity and Likert Assessment.
Placebo change in Neutral Mood
|
.602 units on a scale
Standard Deviation 1.7237
|
1.192 units on a scale
Standard Deviation 1.476
|
—
|
|
Activity of SXC-2023 on Measures of Abstinence Induced Urge for Cigarettes and Mood, Assessed by Cue Reactivity and Likert Assessment.
SXC-2023 change in Positive Urge
|
.5 units on a scale
Standard Deviation 1.922
|
.12 units on a scale
Standard Deviation 1.793
|
—
|
|
Activity of SXC-2023 on Measures of Abstinence Induced Urge for Cigarettes and Mood, Assessed by Cue Reactivity and Likert Assessment.
Placebo change in Positive Urge
|
-.12 units on a scale
Standard Deviation 1.543
|
-.04 units on a scale
Standard Deviation 1.547
|
—
|
|
Activity of SXC-2023 on Measures of Abstinence Induced Urge for Cigarettes and Mood, Assessed by Cue Reactivity and Likert Assessment.
SXC-2023 change in Positive Mood
|
1.23 units on a scale
Standard Deviation 1.509
|
1.35 units on a scale
Standard Deviation 2.065
|
—
|
|
Activity of SXC-2023 on Measures of Abstinence Induced Urge for Cigarettes and Mood, Assessed by Cue Reactivity and Likert Assessment.
Placebo change in Positive Mood
|
.73 units on a scale
Standard Deviation 1.666
|
1.38 units on a scale
Standard Deviation 1.557
|
—
|
|
Activity of SXC-2023 on Measures of Abstinence Induced Urge for Cigarettes and Mood, Assessed by Cue Reactivity and Likert Assessment.
SXC-2023 change in Smoking Urge
|
.39 units on a scale
Standard Deviation 2.105
|
-.23 units on a scale
Standard Deviation 1.549
|
—
|
|
Activity of SXC-2023 on Measures of Abstinence Induced Urge for Cigarettes and Mood, Assessed by Cue Reactivity and Likert Assessment.
Placebo change in Smoking Urge
|
-.65 units on a scale
Standard Deviation 1.864
|
-.27 units on a scale
Standard Deviation 1.653
|
—
|
|
Activity of SXC-2023 on Measures of Abstinence Induced Urge for Cigarettes and Mood, Assessed by Cue Reactivity and Likert Assessment.
SXC-2023 change in Smoking Mood
|
.42 units on a scale
Standard Deviation 1.352
|
1.65 units on a scale
Standard Deviation 1.796
|
—
|
|
Activity of SXC-2023 on Measures of Abstinence Induced Urge for Cigarettes and Mood, Assessed by Cue Reactivity and Likert Assessment.
Placebo change in Smoking Mood
|
.88 units on a scale
Standard Deviation 1.431
|
1 units on a scale
Standard Deviation 1.339
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 5 days.Population: Subjects who did not complete treatment with both placebo and SXC-2023 were excluded from analysis.
Levels total and/or reduced of GSH in whole blood will be collected at baseline (prior to dosing on Day 1) and after 5 days of tobacco abstinence (after dosing on Day 5). Subject scores were collected pre-dose on day 1 of treatment and post-dose on day 5 of treatment.
Outcome measures
| Measure |
During 200 mg SXC-2023 Treatment
n=14 Participants
AEs observed during treatment with SXC-2023 200 mg.
|
During 800 mg SXC-2023 Treatment
n=14 Participants
AEs observed during treatment with SXC-2023 800 mg.
|
During Placebo Treatment
AEs observed during treatment with Placebo.
|
|---|---|---|---|
|
Levels of Glutathione (GSH) in Whole Blood Following 5 Days of Tobacco Abstinence.
SXC-2023 change in GSH concentration
|
-3.45 μg/mL
Standard Deviation 23.318
|
-20.6 μg/mL
Standard Deviation 73.23
|
—
|
|
Levels of Glutathione (GSH) in Whole Blood Following 5 Days of Tobacco Abstinence.
Placebo change in GSH concentration
|
-5.13 μg/mL
Standard Deviation 21.826
|
-5.12 μg/mL
Standard Deviation 23.587
|
—
|
Adverse Events
During 200 mg SXC-2023 Treatment
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
During 800 mg SXC-2023 Treatment
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
During Placebo Treatment
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
During 200 mg SXC-2023 Treatment
n=16 participants at risk
AEs observed during treatment with SXC-2023 200 mg.
|
During 800 mg SXC-2023 Treatment
n=16 participants at risk
AEs observed during treatment with SXC-2023 800 mg.
|
During Placebo Treatment
n=31 participants at risk
AEs observed during treatment with Placebo.
|
|---|---|---|---|
|
Nervous system disorders
Headache
|
12.5%
2/16 • 5 day treatment period, and following 9 days.
|
0.00%
0/16 • 5 day treatment period, and following 9 days.
|
6.5%
2/31 • 5 day treatment period, and following 9 days.
|
|
Gastrointestinal disorders
Dry Mouth
|
0.00%
0/16 • 5 day treatment period, and following 9 days.
|
0.00%
0/16 • 5 day treatment period, and following 9 days.
|
6.5%
2/31 • 5 day treatment period, and following 9 days.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/16 • 5 day treatment period, and following 9 days.
|
0.00%
0/16 • 5 day treatment period, and following 9 days.
|
3.2%
1/31 • 5 day treatment period, and following 9 days.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/16 • 5 day treatment period, and following 9 days.
|
0.00%
0/16 • 5 day treatment period, and following 9 days.
|
3.2%
1/31 • 5 day treatment period, and following 9 days.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/16 • 5 day treatment period, and following 9 days.
|
0.00%
0/16 • 5 day treatment period, and following 9 days.
|
3.2%
1/31 • 5 day treatment period, and following 9 days.
|
|
Gastrointestinal disorders
Defecation Urgency
|
6.2%
1/16 • 5 day treatment period, and following 9 days.
|
0.00%
0/16 • 5 day treatment period, and following 9 days.
|
0.00%
0/31 • 5 day treatment period, and following 9 days.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/16 • 5 day treatment period, and following 9 days.
|
0.00%
0/16 • 5 day treatment period, and following 9 days.
|
3.2%
1/31 • 5 day treatment period, and following 9 days.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/16 • 5 day treatment period, and following 9 days.
|
0.00%
0/16 • 5 day treatment period, and following 9 days.
|
6.5%
2/31 • 5 day treatment period, and following 9 days.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/16 • 5 day treatment period, and following 9 days.
|
0.00%
0/16 • 5 day treatment period, and following 9 days.
|
6.5%
2/31 • 5 day treatment period, and following 9 days.
|
|
General disorders
Thirst
|
0.00%
0/16 • 5 day treatment period, and following 9 days.
|
0.00%
0/16 • 5 day treatment period, and following 9 days.
|
3.2%
1/31 • 5 day treatment period, and following 9 days.
|
|
Injury, poisoning and procedural complications
Laceration
|
6.2%
1/16 • 5 day treatment period, and following 9 days.
|
6.2%
1/16 • 5 day treatment period, and following 9 days.
|
0.00%
0/31 • 5 day treatment period, and following 9 days.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/16 • 5 day treatment period, and following 9 days.
|
0.00%
0/16 • 5 day treatment period, and following 9 days.
|
3.2%
1/31 • 5 day treatment period, and following 9 days.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
6.2%
1/16 • 5 day treatment period, and following 9 days.
|
0.00%
0/16 • 5 day treatment period, and following 9 days.
|
3.2%
1/31 • 5 day treatment period, and following 9 days.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/16 • 5 day treatment period, and following 9 days.
|
0.00%
0/16 • 5 day treatment period, and following 9 days.
|
3.2%
1/31 • 5 day treatment period, and following 9 days.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/16 • 5 day treatment period, and following 9 days.
|
0.00%
0/16 • 5 day treatment period, and following 9 days.
|
6.5%
2/31 • 5 day treatment period, and following 9 days.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/16 • 5 day treatment period, and following 9 days.
|
0.00%
0/16 • 5 day treatment period, and following 9 days.
|
3.2%
1/31 • 5 day treatment period, and following 9 days.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/16 • 5 day treatment period, and following 9 days.
|
0.00%
0/16 • 5 day treatment period, and following 9 days.
|
3.2%
1/31 • 5 day treatment period, and following 9 days.
|
|
Nervous system disorders
Somnolence
|
6.2%
1/16 • 5 day treatment period, and following 9 days.
|
6.2%
1/16 • 5 day treatment period, and following 9 days.
|
3.2%
1/31 • 5 day treatment period, and following 9 days.
|
|
Psychiatric disorders
Anger
|
0.00%
0/16 • 5 day treatment period, and following 9 days.
|
6.2%
1/16 • 5 day treatment period, and following 9 days.
|
3.2%
1/31 • 5 day treatment period, and following 9 days.
|
|
Psychiatric disorders
Emotional disorder
|
0.00%
0/16 • 5 day treatment period, and following 9 days.
|
6.2%
1/16 • 5 day treatment period, and following 9 days.
|
0.00%
0/31 • 5 day treatment period, and following 9 days.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.2%
1/16 • 5 day treatment period, and following 9 days.
|
0.00%
0/16 • 5 day treatment period, and following 9 days.
|
3.2%
1/31 • 5 day treatment period, and following 9 days.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/16 • 5 day treatment period, and following 9 days.
|
0.00%
0/16 • 5 day treatment period, and following 9 days.
|
6.5%
2/31 • 5 day treatment period, and following 9 days.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/16 • 5 day treatment period, and following 9 days.
|
0.00%
0/16 • 5 day treatment period, and following 9 days.
|
3.2%
1/31 • 5 day treatment period, and following 9 days.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/16 • 5 day treatment period, and following 9 days.
|
0.00%
0/16 • 5 day treatment period, and following 9 days.
|
3.2%
1/31 • 5 day treatment period, and following 9 days.
|
|
Eye disorders
Lacrimation increase
|
0.00%
0/16 • 5 day treatment period, and following 9 days.
|
0.00%
0/16 • 5 day treatment period, and following 9 days.
|
3.2%
1/31 • 5 day treatment period, and following 9 days.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place