Trial Outcomes & Findings for HLAB-002 of ANS-6637 for Alcohol Use Disorder (NCT NCT03970109)
NCT ID: NCT03970109
Last Updated: 2024-10-29
Results Overview
The primary efficacy endpoint is the change in the "strength" of alcohol craving Visual Analog Scale (VAS) score for the question, "How strong is your craving to drink alcohol," in response to an alcohol cue at Week 2 - after one week of investigational product treatment. The VAS has a minimum=0 and maximum=20 with higher values indicative of greater craving for alcohol (a worse outcome).
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
43 participants
Primary outcome timeframe
Week 2
Results posted on
2024-10-29
Participant Flow
Participants were recruited between October 8, 2019 and May 22, 2020. Participant recruitment methods at each site will be based on their local population; however, standard tactics will be used (including but not limited to: flyers, social media, newspaper advertisements, radio advertisements, and television advertisements).
n=132 participants were assessed for eligibility. n=89 were excluded prior to randomization for the following reasons: Drinking entry criteria (25%) Screening Cue VAS Score (16%) Vital signs (15%) Positive urine drug test (9%) Other (36%)
Participant milestones
| Measure |
ANS-6637 - 200mg
200 mg ANS-6637 (given as 2 x 100 mg tablet) once a day
ANS-6637: 200 mg (given as 2 x 100 mg tablet) and 600 mg (given as 2 x 300 mg tablet) once a day
|
ANS-6637 - 600mg
600 mg ANS-6637 (given as 2 x 300 mg tablet) once a day
ANS-6637: 200 mg (given as 2 x 100 mg tablet) and 600 mg (given as 2 x 300 mg tablet) once a day
|
Matched Placebo
2 placebo tablets once a day
Placebo oral tablet: Placebo oral tablet
|
|---|---|---|---|
|
Overall Study
STARTED
|
15
|
13
|
15
|
|
Overall Study
COMPLETED
|
14
|
10
|
15
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
HLAB-002 of ANS-6637 for Alcohol Use Disorder
Baseline characteristics by cohort
| Measure |
ANS-6637 - 200mg
n=14 Participants
200 mg ANS-6637 (given as 2 x 100 mg tablet) once a day
ANS-6637: 200 mg (given as 2 x 100 mg tablet) and 600 mg (given as 2 x 300 mg tablet) once a day
|
ANS-6637 - 600mg
n=10 Participants
600 mg ANS-6637 (given as 2 x 300 mg tablet) once a day
ANS-6637: 200 mg (given as 2 x 100 mg tablet) and 600 mg (given as 2 x 300 mg tablet) once a day
|
Matched Placebo
n=15 Participants
2 placebo tablets once a day
Placebo oral tablet: Placebo oral tablet
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
43.4 years
STANDARD_DEVIATION 13.3 • n=5 Participants
|
47.3 years
STANDARD_DEVIATION 10.1 • n=7 Participants
|
49.8 years
STANDARD_DEVIATION 12.8 • n=5 Participants
|
46.9 years
STANDARD_DEVIATION 12.4 • n=4 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
37 Participants
n=4 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
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 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
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
10 participants
n=7 Participants
|
15 participants
n=5 Participants
|
39 participants
n=4 Participants
|
|
Drinks per Week (28 days before randomization)
|
61.2 standard drinking units (SDUs)
STANDARD_DEVIATION 20.1 • n=5 Participants
|
46.9 standard drinking units (SDUs)
STANDARD_DEVIATION 15.5 • n=7 Participants
|
64.1 standard drinking units (SDUs)
STANDARD_DEVIATION 29.8 • n=5 Participants
|
56.6 standard drinking units (SDUs)
STANDARD_DEVIATION 24.0 • n=4 Participants
|
PRIMARY outcome
Timeframe: Week 2Population: The analysis population is based on the modified intention-to-treat (mITT) analysis set, defined as subjects randomized to participate in the study that took at least one dose of IP and had a non-missing VAS craving primary endpoint.
The primary efficacy endpoint is the change in the "strength" of alcohol craving Visual Analog Scale (VAS) score for the question, "How strong is your craving to drink alcohol," in response to an alcohol cue at Week 2 - after one week of investigational product treatment. The VAS has a minimum=0 and maximum=20 with higher values indicative of greater craving for alcohol (a worse outcome).
Outcome measures
| Measure |
ANS-6637 - 200mg
n=14 Participants
200 mg ANS-6637 (given as 2 x 100 mg tablet) once a day
ANS-6637: 200 mg (given as 2 x 100 mg tablet) and 600 mg (given as 2 x 300 mg tablet) once a day
|
ANS-6637 - 600mg
n=10 Participants
600 mg ANS-6637 (given as 2 x 300 mg tablet) once a day
ANS-6637: 200 mg (given as 2 x 100 mg tablet) and 600 mg (given as 2 x 300 mg tablet) once a day
|
Matched Placebo
n=15 Participants
2 placebo tablets once a day
Placebo oral tablet: Placebo oral tablet
|
|---|---|---|---|
|
Craving - "How Strong is Your Craving to Drink Alcohol" Visual Analog Scale (VAS) Item
|
3.91 score on a scale
Standard Error 1.30
|
6.91 score on a scale
Standard Error 13.0
|
7.27 score on a scale
Standard Error 1.25
|
SECONDARY outcome
Timeframe: Last 4 weeks of treatment, from Week 2 to Week 5Population: mITT
Number of subjects that have no heavy drinking days during the last 4 weeks of treatment. A "heavy drinking day" is 4 or more drinks per drinking day for women and 5 or more drinks per drinking day for men.
Outcome measures
| Measure |
ANS-6637 - 200mg
n=14 Participants
200 mg ANS-6637 (given as 2 x 100 mg tablet) once a day
ANS-6637: 200 mg (given as 2 x 100 mg tablet) and 600 mg (given as 2 x 300 mg tablet) once a day
|
ANS-6637 - 600mg
n=10 Participants
600 mg ANS-6637 (given as 2 x 300 mg tablet) once a day
ANS-6637: 200 mg (given as 2 x 100 mg tablet) and 600 mg (given as 2 x 300 mg tablet) once a day
|
Matched Placebo
n=15 Participants
2 placebo tablets once a day
Placebo oral tablet: Placebo oral tablet
|
|---|---|---|---|
|
Number of Subjects With no Heavy Drinking Days
|
0 Participants
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Last 4 weeks of treatment, from Week 2 to Week 5Population: mITT
Number of subjects that have not drank alcohol during the last 4 weeks of treatment.
Outcome measures
| Measure |
ANS-6637 - 200mg
n=14 Participants
200 mg ANS-6637 (given as 2 x 100 mg tablet) once a day
ANS-6637: 200 mg (given as 2 x 100 mg tablet) and 600 mg (given as 2 x 300 mg tablet) once a day
|
ANS-6637 - 600mg
n=10 Participants
600 mg ANS-6637 (given as 2 x 300 mg tablet) once a day
ANS-6637: 200 mg (given as 2 x 100 mg tablet) and 600 mg (given as 2 x 300 mg tablet) once a day
|
Matched Placebo
n=15 Participants
2 placebo tablets once a day
Placebo oral tablet: Placebo oral tablet
|
|---|---|---|---|
|
Number of Subjects Abstinent From Alcohol
|
0 Participants
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Last 4 weeks of treatment, from Week 2 to Week 5Population: mITT
The number of subjects experiencing at least a 1-level decrease in World Health Organization (WHO) levels of alcohol consumption from the level at baseline (the period including the 28 days before screening) to the level during the last 4 weeks of treatment. The WHO levels of average alcohol consumption per day are as follows: Males Females Low Risk 1 to 40g 1 to 20g Medium Risk 41 to 60g 21 to 40g High Risk 61 to 100g 41 to 60g Very High Risk 101+g 61+g where 14g = 1 SDU (WHO-2000). In computing the WHO alcohol consumption level, average drinks per day were used, computed as the sum of all drinks in the 28 day period divided by the number of days with non-missing drinking data in that period. Abstinent subjects were included in a separate "Abstinent" category.
Outcome measures
| Measure |
ANS-6637 - 200mg
n=14 Participants
200 mg ANS-6637 (given as 2 x 100 mg tablet) once a day
ANS-6637: 200 mg (given as 2 x 100 mg tablet) and 600 mg (given as 2 x 300 mg tablet) once a day
|
ANS-6637 - 600mg
n=10 Participants
600 mg ANS-6637 (given as 2 x 300 mg tablet) once a day
ANS-6637: 200 mg (given as 2 x 100 mg tablet) and 600 mg (given as 2 x 300 mg tablet) once a day
|
Matched Placebo
n=15 Participants
2 placebo tablets once a day
Placebo oral tablet: Placebo oral tablet
|
|---|---|---|---|
|
WHO 1-level Decrease in Alcohol Consumption
|
12 Participants
|
10 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Last 4 weeks of treatment, from Week 2 to Week 5Population: mITT
The number of subjects experiencing at least a 2-level decrease in World Health Organization (WHO) levels of alcohol consumption from the level at baseline (the period including the 28 days before screening) to the level during the last 4 weeks of treatment. The WHO levels of average alcohol consumption per day are as follows: Males Females Low Risk 1 to 40g 1 to 20g Medium Risk 41 to 60g 21 to 40g High Risk 61 to 100g 41 to 60g Very High Risk 101+g 61+g where 14g = 1 SDU (WHO-2000). In computing the WHO alcohol consumption level, average drinks per day were used, computed as the sum of all drinks in the 28 day period divided by the number of days with non-missing drinking data in that period. Abstinent subjects were included in a separate "Abstinent" category.
Outcome measures
| Measure |
ANS-6637 - 200mg
n=14 Participants
200 mg ANS-6637 (given as 2 x 100 mg tablet) once a day
ANS-6637: 200 mg (given as 2 x 100 mg tablet) and 600 mg (given as 2 x 300 mg tablet) once a day
|
ANS-6637 - 600mg
n=10 Participants
600 mg ANS-6637 (given as 2 x 300 mg tablet) once a day
ANS-6637: 200 mg (given as 2 x 100 mg tablet) and 600 mg (given as 2 x 300 mg tablet) once a day
|
Matched Placebo
n=15 Participants
2 placebo tablets once a day
Placebo oral tablet: Placebo oral tablet
|
|---|---|---|---|
|
WHO 2-level Decrease in Alcohol Consumption
|
6 Participants
|
6 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Last 4 weeks of treatment, from Week 2 to Week 5Population: mITT
The percentage of days abstinent from drinking alcohol
Outcome measures
| Measure |
ANS-6637 - 200mg
n=14 Participants
200 mg ANS-6637 (given as 2 x 100 mg tablet) once a day
ANS-6637: 200 mg (given as 2 x 100 mg tablet) and 600 mg (given as 2 x 300 mg tablet) once a day
|
ANS-6637 - 600mg
n=10 Participants
600 mg ANS-6637 (given as 2 x 300 mg tablet) once a day
ANS-6637: 200 mg (given as 2 x 100 mg tablet) and 600 mg (given as 2 x 300 mg tablet) once a day
|
Matched Placebo
n=15 Participants
2 placebo tablets once a day
Placebo oral tablet: Placebo oral tablet
|
|---|---|---|---|
|
Percentage of Days Abstinent
|
32.3 percentage of days abstinent
Interval 19.3 to 53.2
|
51.3 percentage of days abstinent
Interval 30.8 to 71.8
|
38.1 percentage of days abstinent
Interval 21.4 to 54.8
|
SECONDARY outcome
Timeframe: Last 4 weeks of treatment, from Week 2 to Week 5Population: mITT
Percentage of heavy drinking days where a heavy drinking day is 4 or more drinks on a day for women or 5 or more drinks on a day for men.
Outcome measures
| Measure |
ANS-6637 - 200mg
n=14 Participants
200 mg ANS-6637 (given as 2 x 100 mg tablet) once a day
ANS-6637: 200 mg (given as 2 x 100 mg tablet) and 600 mg (given as 2 x 300 mg tablet) once a day
|
ANS-6637 - 600mg
n=10 Participants
600 mg ANS-6637 (given as 2 x 300 mg tablet) once a day
ANS-6637: 200 mg (given as 2 x 100 mg tablet) and 600 mg (given as 2 x 300 mg tablet) once a day
|
Matched Placebo
n=15 Participants
2 placebo tablets once a day
Placebo oral tablet: Placebo oral tablet
|
|---|---|---|---|
|
Percentage of Heavy Drinking Days
|
37.0 percentage of heavy drinking days
Interval 20.5 to 53.5
|
26.5 percentage of heavy drinking days
Interval 6.0 to 47.1
|
40.8 percentage of heavy drinking days
Interval 25.0 to 56.7
|
SECONDARY outcome
Timeframe: Last 4 weeks of treatment, from Week 2 to Week 5Population: mITT
Percentage of very heavy drinking days where a very heavy drinking day is defined as 8 or more drinks on a day for women and 10 or more drinks on a day for men.
Outcome measures
| Measure |
ANS-6637 - 200mg
n=14 Participants
200 mg ANS-6637 (given as 2 x 100 mg tablet) once a day
ANS-6637: 200 mg (given as 2 x 100 mg tablet) and 600 mg (given as 2 x 300 mg tablet) once a day
|
ANS-6637 - 600mg
n=10 Participants
600 mg ANS-6637 (given as 2 x 300 mg tablet) once a day
ANS-6637: 200 mg (given as 2 x 100 mg tablet) and 600 mg (given as 2 x 300 mg tablet) once a day
|
Matched Placebo
n=15 Participants
2 placebo tablets once a day
Placebo oral tablet: Placebo oral tablet
|
|---|---|---|---|
|
Percentage of Very Heavy Drinking Days
|
8.0 percentage of very heavy drinking days
Interval -0.2 to 16.2
|
3.8 percentage of very heavy drinking days
Interval -6.2 to 13.7
|
9.1 percentage of very heavy drinking days
Interval 1.2 to 17.0
|
SECONDARY outcome
Timeframe: Last 4 weeks of treatment, from Week 2 to Week 5Population: mITT
The number of drinks consumed per week
Outcome measures
| Measure |
ANS-6637 - 200mg
n=14 Participants
200 mg ANS-6637 (given as 2 x 100 mg tablet) once a day
ANS-6637: 200 mg (given as 2 x 100 mg tablet) and 600 mg (given as 2 x 300 mg tablet) once a day
|
ANS-6637 - 600mg
n=10 Participants
600 mg ANS-6637 (given as 2 x 300 mg tablet) once a day
ANS-6637: 200 mg (given as 2 x 100 mg tablet) and 600 mg (given as 2 x 300 mg tablet) once a day
|
Matched Placebo
n=15 Participants
2 placebo tablets once a day
Placebo oral tablet: Placebo oral tablet
|
|---|---|---|---|
|
Drinks Per Week
|
24.3 standard drinking units (SDUs)
Interval 14.6 to 34.0
|
19.0 standard drinking units (SDUs)
Interval 6.8 to 31.1
|
27.2 standard drinking units (SDUs)
Interval 17.7 to 36.7
|
SECONDARY outcome
Timeframe: Last 4 weeks of treatment, from Week 2 to Week 5Population: mITT
The number of drinks consumed on days where participants drank
Outcome measures
| Measure |
ANS-6637 - 200mg
n=14 Participants
200 mg ANS-6637 (given as 2 x 100 mg tablet) once a day
ANS-6637: 200 mg (given as 2 x 100 mg tablet) and 600 mg (given as 2 x 300 mg tablet) once a day
|
ANS-6637 - 600mg
n=10 Participants
600 mg ANS-6637 (given as 2 x 300 mg tablet) once a day
ANS-6637: 200 mg (given as 2 x 100 mg tablet) and 600 mg (given as 2 x 300 mg tablet) once a day
|
Matched Placebo
n=15 Participants
2 placebo tablets once a day
Placebo oral tablet: Placebo oral tablet
|
|---|---|---|---|
|
Drinks Per Drinking Day
|
5.4 standard drinking units (SDUs)
Interval 4.4 to 6.4
|
4.7 standard drinking units (SDUs)
Interval 3.3 to 6.1
|
6.1 standard drinking units (SDUs)
Interval 5.1 to 7.2
|
SECONDARY outcome
Timeframe: Last 4 weeks of treatment, from Week 2 to Week 5The amount of craving; higher numbers indicate more craving. There are 5 items each on a 0 to 6 scale. Items are summed to get to the total craving, resulting in scores having a min=0 and max=30.
Outcome measures
| Measure |
ANS-6637 - 200mg
n=14 Participants
200 mg ANS-6637 (given as 2 x 100 mg tablet) once a day
ANS-6637: 200 mg (given as 2 x 100 mg tablet) and 600 mg (given as 2 x 300 mg tablet) once a day
|
ANS-6637 - 600mg
n=10 Participants
600 mg ANS-6637 (given as 2 x 300 mg tablet) once a day
ANS-6637: 200 mg (given as 2 x 100 mg tablet) and 600 mg (given as 2 x 300 mg tablet) once a day
|
Matched Placebo
n=15 Participants
2 placebo tablets once a day
Placebo oral tablet: Placebo oral tablet
|
|---|---|---|---|
|
Penn Alcohol Craving Scale (PACS)
|
12.0 score on a scale
Interval 9.5 to 14.5
|
11.3 score on a scale
Interval 8.4 to 14.2
|
12.0 score on a scale
Interval 9.6 to 14.3
|
SECONDARY outcome
Timeframe: Last 4 weeks of treatment, from Week 2 to Week 5Population: mITT
A measure of sleep quality; the PSQI includes a scoring key for calculating a patient's seven subscores, each of which can range from 0 to 3. The subscores are tallied, yielding a "global" score that can range from 0 to 21. A global score of 5 or more indicates poor sleep quality; the higher the score, the worse the quality.
Outcome measures
| Measure |
ANS-6637 - 200mg
n=14 Participants
200 mg ANS-6637 (given as 2 x 100 mg tablet) once a day
ANS-6637: 200 mg (given as 2 x 100 mg tablet) and 600 mg (given as 2 x 300 mg tablet) once a day
|
ANS-6637 - 600mg
n=10 Participants
600 mg ANS-6637 (given as 2 x 300 mg tablet) once a day
ANS-6637: 200 mg (given as 2 x 100 mg tablet) and 600 mg (given as 2 x 300 mg tablet) once a day
|
Matched Placebo
n=15 Participants
2 placebo tablets once a day
Placebo oral tablet: Placebo oral tablet
|
|---|---|---|---|
|
Pittsburgh Sleep Quality Index (PSQI)
|
6.6 score on a scale
Interval 5.1 to 8.1
|
6.2 score on a scale
Interval 4.6 to 7.9
|
5.0 score on a scale
Interval 3.8 to 6.3
|
SECONDARY outcome
Timeframe: Last 4 weeks of treatment, from Week 2 to Week 5Population: mITT
A measure of alcohol-related negative consequences. There are 7 items scored on a 1 to 7 scale (a higher score indicative greater frequency of negative consequences). The items are summed and converted to a T-score to create a total score. The T-scores range from 0 to 100 (the population mean = 50 and standard deviation = 10). Higher T-scores are indicative of more negative consequences (worse outcome).
Outcome measures
| Measure |
ANS-6637 - 200mg
n=14 Participants
200 mg ANS-6637 (given as 2 x 100 mg tablet) once a day
ANS-6637: 200 mg (given as 2 x 100 mg tablet) and 600 mg (given as 2 x 300 mg tablet) once a day
|
ANS-6637 - 600mg
n=10 Participants
600 mg ANS-6637 (given as 2 x 300 mg tablet) once a day
ANS-6637: 200 mg (given as 2 x 100 mg tablet) and 600 mg (given as 2 x 300 mg tablet) once a day
|
Matched Placebo
n=15 Participants
2 placebo tablets once a day
Placebo oral tablet: Placebo oral tablet
|
|---|---|---|---|
|
Patient-Reported Outcomes Measurement Information System (PROMIS) Alcohol Related Negative Consequences
|
47.8 T-score
Interval 44.7 to 50.4
|
45.9 T-score
Interval 42.3 to 49.6
|
50.7 T-score
Interval 50.0 to 53.3
|
SECONDARY outcome
Timeframe: Last 4 weeks of treatment, from Week 2 to Week 5Population: mITT
A measure of total mood disturbance. Total mood disturbance is the sum of depression, anger, fatigue, confusion, and tension subscales subtracting the vigor subscale items. The range of possible scores is from -32 to 200 with higher scores indicating greater mood disturbance.
Outcome measures
| Measure |
ANS-6637 - 200mg
n=14 Participants
200 mg ANS-6637 (given as 2 x 100 mg tablet) once a day
ANS-6637: 200 mg (given as 2 x 100 mg tablet) and 600 mg (given as 2 x 300 mg tablet) once a day
|
ANS-6637 - 600mg
n=10 Participants
600 mg ANS-6637 (given as 2 x 300 mg tablet) once a day
ANS-6637: 200 mg (given as 2 x 100 mg tablet) and 600 mg (given as 2 x 300 mg tablet) once a day
|
Matched Placebo
n=15 Participants
2 placebo tablets once a day
Placebo oral tablet: Placebo oral tablet
|
|---|---|---|---|
|
Profile of Mood States (POMS) Total Disturbance
|
-2.0 score on a scale
Interval -12.9 to 8.9
|
3.9 score on a scale
Interval -7.8 to 15.7
|
9.1 score on a scale
Interval -0.4 to 18.7
|
SECONDARY outcome
Timeframe: Week 2Population: The analysis population is based on the modified intention-to-treat (mITT) analysis set, defined as subjects randomized to participate in the study that took at least one dose of IP and had a non-missing VAS craving primary endpoint.
This secondary efficacy endpoint is the change in the Visual Analog Scale (VAS) score for the question, "Having a drink would make things just perfect," in response to an alcohol cue at Week 2 - after one week of investigational product treatment. The VAS has a minimum=0 and maximum=20 with higher values indicative of greater craving for alcohol (a worse outcome).
Outcome measures
| Measure |
ANS-6637 - 200mg
n=14 Participants
200 mg ANS-6637 (given as 2 x 100 mg tablet) once a day
ANS-6637: 200 mg (given as 2 x 100 mg tablet) and 600 mg (given as 2 x 300 mg tablet) once a day
|
ANS-6637 - 600mg
n=10 Participants
600 mg ANS-6637 (given as 2 x 300 mg tablet) once a day
ANS-6637: 200 mg (given as 2 x 100 mg tablet) and 600 mg (given as 2 x 300 mg tablet) once a day
|
Matched Placebo
n=15 Participants
2 placebo tablets once a day
Placebo oral tablet: Placebo oral tablet
|
|---|---|---|---|
|
Craving - "Having a Drink Would Making Things Just Perfect" Visual Analog Scale (VAS) Item
|
3.72 score on a scale
Standard Error 1.43
|
5.23 score on a scale
Standard Error 3.72
|
6.38 score on a scale
Standard Error 1.40
|
SECONDARY outcome
Timeframe: Week 2Population: The analysis population is based on the modified intention-to-treat (mITT) analysis set, defined as subjects randomized to participate in the study that took at least one dose of IP and had a non-missing VAS craving primary endpoint.
This secondary efficacy endpoint is the change in the Visual Analog Scale (VAS) score for the question, "If I could drink alcohol now, I would drink it," in response to an alcohol cue at Week 2 - after one week of investigational product treatment. The VAS has a minimum=0 and maximum=20 with higher values indicative of greater craving for alcohol (a worse outcome).
Outcome measures
| Measure |
ANS-6637 - 200mg
n=14 Participants
200 mg ANS-6637 (given as 2 x 100 mg tablet) once a day
ANS-6637: 200 mg (given as 2 x 100 mg tablet) and 600 mg (given as 2 x 300 mg tablet) once a day
|
ANS-6637 - 600mg
n=10 Participants
600 mg ANS-6637 (given as 2 x 300 mg tablet) once a day
ANS-6637: 200 mg (given as 2 x 100 mg tablet) and 600 mg (given as 2 x 300 mg tablet) once a day
|
Matched Placebo
n=15 Participants
2 placebo tablets once a day
Placebo oral tablet: Placebo oral tablet
|
|---|---|---|---|
|
Craving - "If I Could Drink Alcohol Now, I Would Drink it" Visual Analog Scale (VAS) Item
|
5.67 score on a scale
Standard Error 1.65
|
8.41 score on a scale
Standard Error 2.05
|
6.69 score on a scale
Standard Error 1.63
|
SECONDARY outcome
Timeframe: Week 2Population: The analysis population is based on the modified intention-to-treat (mITT) analysis set, defined as subjects randomized to participate in the study that took at least one dose of IP and had a non-missing VAS craving primary endpoint.
This secondary efficacy endpoint is the change in the Visual Analog Scale (VAS) score for the question, "It would be hard to turn down a drink right now," in response to an alcohol cue at Week 2 - after one week of investigational product treatment. The VAS has a minimum=0 and maximum=20 with higher values indicative of greater craving for alcohol (a worse outcome).
Outcome measures
| Measure |
ANS-6637 - 200mg
n=14 Participants
200 mg ANS-6637 (given as 2 x 100 mg tablet) once a day
ANS-6637: 200 mg (given as 2 x 100 mg tablet) and 600 mg (given as 2 x 300 mg tablet) once a day
|
ANS-6637 - 600mg
n=10 Participants
600 mg ANS-6637 (given as 2 x 300 mg tablet) once a day
ANS-6637: 200 mg (given as 2 x 100 mg tablet) and 600 mg (given as 2 x 300 mg tablet) once a day
|
Matched Placebo
n=15 Participants
2 placebo tablets once a day
Placebo oral tablet: Placebo oral tablet
|
|---|---|---|---|
|
Craving - "It Would be Hard to Turn Down a Drink Right Now" Visual Analog Scale (VAS) Item
|
3.37 score on a scale
Standard Error 1.42
|
7.46 score on a scale
Standard Error 1.74
|
6.82 score on a scale
Standard Error 1.38
|
Adverse Events
ANS-6637 - 200mg
Serious events: 2 serious events
Other events: 15 other events
Deaths: 0 deaths
ANS-6637 - 600mg
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Matched Placebo
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ANS-6637 - 200mg
n=15 participants at risk
200 mg ANS-6637 (given as 2 x 100 mg tablet) once a day
ANS-6637: 200 mg (given as 2 x 100 mg tablet) and 600 mg (given as 2 x 300 mg tablet) once a day
|
ANS-6637 - 600mg
n=13 participants at risk
600 mg ANS-6637 (given as 2 x 300 mg tablet) once a day
ANS-6637: 200 mg (given as 2 x 100 mg tablet) and 600 mg (given as 2 x 300 mg tablet) once a day
|
Matched Placebo
n=15 participants at risk
2 placebo tablets once a day
Placebo oral tablet: Placebo oral tablet
|
|---|---|---|---|
|
Psychiatric disorders
Alcohol Rehabilitation
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/13 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/15 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
|
Hepatobiliary disorders
Drug-Induced Liver Injury
|
0.00%
0/15 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
7.7%
1/13 • Number of events 1 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/15 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
|
Hepatobiliary disorders
Alanine-Aminotransferase Increased
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/13 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/15 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
Other adverse events
| Measure |
ANS-6637 - 200mg
n=15 participants at risk
200 mg ANS-6637 (given as 2 x 100 mg tablet) once a day
ANS-6637: 200 mg (given as 2 x 100 mg tablet) and 600 mg (given as 2 x 300 mg tablet) once a day
|
ANS-6637 - 600mg
n=13 participants at risk
600 mg ANS-6637 (given as 2 x 300 mg tablet) once a day
ANS-6637: 200 mg (given as 2 x 100 mg tablet) and 600 mg (given as 2 x 300 mg tablet) once a day
|
Matched Placebo
n=15 participants at risk
2 placebo tablets once a day
Placebo oral tablet: Placebo oral tablet
|
|---|---|---|---|
|
Cardiac disorders
BRADYCARDIA
|
0.00%
0/15 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/13 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
|
Cardiac disorders
PALPITATIONS
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/13 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/15 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
|
Cardiac disorders
SINUS BRADYCARDIA
|
0.00%
0/15 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/13 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
6.7%
1/15 • Number of events 2 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
|
Ear and labyrinth disorders
EAR DISCOMFORT
|
6.7%
1/15 • Number of events 3 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/13 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/15 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
|
Eye disorders
PHOTOPSIA
|
6.7%
1/15 • Number of events 3 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/13 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/15 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
|
Eye disorders
VISION BLURRED
|
0.00%
0/15 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
7.7%
1/13 • Number of events 1 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
|
Gastrointestinal disorders
ABDOMINAL DISCOMFORT
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
7.7%
1/13 • Number of events 1 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
|
Gastrointestinal disorders
ABDOMINAL DISTENSION
|
0.00%
0/15 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
7.7%
1/13 • Number of events 1 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/15 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/13 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/15 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
|
Gastrointestinal disorders
CONSTIPATION
|
13.3%
2/15 • Number of events 2 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/13 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/15 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
|
Gastrointestinal disorders
DIARRHOEA
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/13 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
|
Gastrointestinal disorders
DRY MOUTH
|
0.00%
0/15 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/13 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
6.7%
1/15 • Number of events 2 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
|
Gastrointestinal disorders
DYSPEPSIA
|
0.00%
0/15 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/13 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
|
Gastrointestinal disorders
NAUSEA
|
13.3%
2/15 • Number of events 2 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
38.5%
5/13 • Number of events 6 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
6.7%
1/15 • Number of events 2 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
|
Gastrointestinal disorders
SWOLLEN TONGUE
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/13 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/15 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
|
Gastrointestinal disorders
TONGUE DISCOMFORT
|
0.00%
0/15 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/13 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
|
Gastrointestinal disorders
TOOTHACHE
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/13 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/15 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
|
Gastrointestinal disorders
VOMITING
|
6.7%
1/15 • Number of events 2 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
23.1%
3/13 • Number of events 3 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/15 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
|
General disorders
ASTHENIA
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/13 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/15 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
|
General disorders
CHEST PAIN
|
6.7%
1/15 • Number of events 2 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/13 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
|
General disorders
CHILLS
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/13 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/15 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
|
General disorders
FATIGUE
|
20.0%
3/15 • Number of events 4 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
7.7%
1/13 • Number of events 1 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
20.0%
3/15 • Number of events 3 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
|
General disorders
FEELING ABNORMAL
|
0.00%
0/15 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/13 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
|
General disorders
FEELING COLD
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/13 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/15 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
|
General disorders
FEELING HOT
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
7.7%
1/13 • Number of events 2 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
20.0%
3/15 • Number of events 5 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/13 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
|
General disorders
PYREXIA
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/13 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/15 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
|
Infections and infestations
BRONCHITIS
|
0.00%
0/15 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/13 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
|
Infections and infestations
FUNGAL INFECTION
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/13 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/15 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
|
Infections and infestations
NASOPHARYNGITIS
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
15.4%
2/13 • Number of events 2 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
|
Injury, poisoning and procedural complications
ALCOHOL POISONING
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/13 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
|
Injury, poisoning and procedural complications
CONCUSSION
|
0.00%
0/15 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/13 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
|
Injury, poisoning and procedural complications
FACIAL BONES FRACTURE
|
0.00%
0/15 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/13 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
|
Injury, poisoning and procedural complications
LIMB INJURY
|
0.00%
0/15 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/13 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
20.0%
3/15 • Number of events 6 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
30.8%
4/13 • Number of events 5 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
26.7%
4/15 • Number of events 4 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
26.7%
4/15 • Number of events 7 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
30.8%
4/13 • Number of events 4 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
20.0%
3/15 • Number of events 3 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
|
Investigations
BLOOD ALBUMIN DECREASED
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/13 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/15 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
|
Investigations
BLOOD ALKALINE PHOSPHATASE DECREASED
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/13 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/15 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
|
Investigations
BLOOD ALKALINE PHOSPHATASE INCREASED
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/13 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/15 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
|
Investigations
BLOOD BILIRUBIN INCREASED
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/13 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/15 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
|
Investigations
BLOOD CREATININE DECREASED
|
13.3%
2/15 • Number of events 3 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
7.7%
1/13 • Number of events 1 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
13.3%
2/15 • Number of events 3 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
|
Investigations
BLOOD PRESSURE DIASTOLIC INCREASED
|
13.3%
2/15 • Number of events 2 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
38.5%
5/13 • Number of events 9 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
33.3%
5/15 • Number of events 5 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
|
Investigations
BLOOD PRESSURE INCREASED
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/13 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
|
Investigations
BLOOD PRESSURE SYSTOLIC INCREASED
|
33.3%
5/15 • Number of events 6 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
23.1%
3/13 • Number of events 3 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
20.0%
3/15 • Number of events 3 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
|
Investigations
BLOOD THYROID STIMULATING HORMONE DECREASED
|
26.7%
4/15 • Number of events 5 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
46.2%
6/13 • Number of events 8 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
|
Investigations
EOSINOPHIL COUNT DECREASED
|
0.00%
0/15 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
7.7%
1/13 • Number of events 1 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/15 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
|
Investigations
EOSINOPHIL COUNT INCREASED
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/13 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
13.3%
2/15 • Number of events 2 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
|
Investigations
GAMMA-GLUTAMYLTRANSFERASE INCREASED
|
13.3%
2/15 • Number of events 4 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
7.7%
1/13 • Number of events 1 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/15 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
|
Investigations
GLUCOSE URINE PRESENT
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/13 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/15 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
|
Investigations
HAEMATOCRIT DECREASED
|
20.0%
3/15 • Number of events 3 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
23.1%
3/13 • Number of events 3 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
13.3%
2/15 • Number of events 2 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
|
Investigations
HEART RATE INCREASED
|
60.0%
9/15 • Number of events 12 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
69.2%
9/13 • Number of events 11 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
6.7%
1/15 • Number of events 2 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
|
Investigations
LYMPHOCYTE COUNT DECREASED
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/13 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
|
Investigations
LYMPHOCYTE COUNT INCREASED
|
0.00%
0/15 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
7.7%
1/13 • Number of events 1 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/15 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
|
Investigations
MONOCYTE COUNT INCREASED
|
13.3%
2/15 • Number of events 2 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
15.4%
2/13 • Number of events 2 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/15 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
|
Investigations
NEUTROPHIL COUNT DECREASED
|
0.00%
0/15 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
7.7%
1/13 • Number of events 1 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
13.3%
2/15 • Number of events 2 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
|
Investigations
NEUTROPHIL COUNT INCREASED
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/13 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
|
Investigations
PLATELET COUNT DECREASED
|
0.00%
0/15 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/13 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
|
Investigations
PLATELET COUNT INCREASED
|
0.00%
0/15 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/13 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
|
Investigations
RED BLOOD CELL COUNT DECREASED
|
33.3%
5/15 • Number of events 5 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
15.4%
2/13 • Number of events 2 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
26.7%
4/15 • Number of events 4 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
|
Investigations
THYROXINE DECREASED
|
0.00%
0/15 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/13 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
13.3%
2/15 • Number of events 2 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
|
Investigations
THYROXINE FREE DECREASED
|
0.00%
0/15 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/13 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
|
Investigations
THYROXINE FREE INCREASED
|
20.0%
3/15 • Number of events 3 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
46.2%
6/13 • Number of events 7 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/15 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
|
Investigations
THYROXINE INCREASED
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/13 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/15 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
|
Investigations
TRI-IODOTHYRONINE DECREASED
|
0.00%
0/15 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/13 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
|
Investigations
TRI-IODOTHYRONINE INCREASED
|
33.3%
5/15 • Number of events 5 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
38.5%
5/13 • Number of events 6 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/15 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
|
Investigations
VITAMIN D DECREASED
|
0.00%
0/15 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
7.7%
1/13 • Number of events 1 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/15 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
|
Investigations
WEIGHT INCREASED
|
0.00%
0/15 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
15.4%
2/13 • Number of events 3 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/15 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
|
Investigations
WHITE BLOOD CELL COUNT DECREASED
|
13.3%
2/15 • Number of events 2 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
7.7%
1/13 • Number of events 1 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/15 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
|
Investigations
WHITE BLOOD CELL COUNT INCREASED
|
20.0%
3/15 • Number of events 3 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/13 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
|
Metabolism and nutrition disorders
ALCOHOL INTOLERANCE
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/13 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/15 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
13.3%
2/15 • Number of events 2 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
30.8%
4/13 • Number of events 4 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
20.0%
3/15 • Number of events 3 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/13 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/15 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
|
Metabolism and nutrition disorders
FOOD CRAVING
|
0.00%
0/15 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
7.7%
1/13 • Number of events 1 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/15 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
0.00%
0/15 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
7.7%
1/13 • Number of events 1 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/15 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
|
Metabolism and nutrition disorders
INCREASED APPETITE
|
33.3%
5/15 • Number of events 5 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
30.8%
4/13 • Number of events 5 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
40.0%
6/15 • Number of events 6 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.00%
0/15 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
7.7%
1/13 • Number of events 2 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/15 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.00%
0/15 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/13 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
0.00%
0/15 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/13 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/13 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/15 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
|
Nervous system disorders
DIZZINESS
|
13.3%
2/15 • Number of events 2 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
7.7%
1/13 • Number of events 1 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
6.7%
1/15 • Number of events 2 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
|
Nervous system disorders
HEADACHE
|
26.7%
4/15 • Number of events 5 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
23.1%
3/13 • Number of events 4 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
40.0%
6/15 • Number of events 9 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
|
Nervous system disorders
HYPOAESTHESIA
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/13 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/15 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
|
Nervous system disorders
PARAESTHESIA
|
0.00%
0/15 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
7.7%
1/13 • Number of events 1 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
13.3%
2/15 • Number of events 2 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
|
Nervous system disorders
RESTLESS LEGS SYNDROME
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/13 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/15 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
|
Nervous system disorders
TREMOR
|
0.00%
0/15 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/13 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
|
Psychiatric disorders
ALCOHOL WITHDRAWAL SYNDROME
|
0.00%
0/15 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
7.7%
1/13 • Number of events 1 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/15 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
|
Psychiatric disorders
ALCOHOLIC HANGOVER
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/13 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
13.3%
2/15 • Number of events 2 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
|
Psychiatric disorders
ALCOHOLISM
|
0.00%
0/15 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/13 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
|
Psychiatric disorders
ANXIETY
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/13 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/15 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
|
Psychiatric disorders
DRUG ABUSE
|
0.00%
0/15 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
7.7%
1/13 • Number of events 1 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/15 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
|
Psychiatric disorders
EMOTIONAL DISORDER
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/13 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/15 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
|
Psychiatric disorders
INSOMNIA
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
7.7%
1/13 • Number of events 1 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/15 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
|
Psychiatric disorders
IRRITABILITY
|
0.00%
0/15 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
7.7%
1/13 • Number of events 1 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/15 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
|
Renal and urinary disorders
CHROMATURIA
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/13 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/15 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
|
Renal and urinary disorders
POLLAKIURIA
|
0.00%
0/15 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/13 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/13 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/15 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
0.00%
0/15 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/13 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
13.3%
2/15 • Number of events 2 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/13 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/15 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
|
0.00%
0/15 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/13 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
13.3%
2/15 • Number of events 4 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
0.00%
0/15 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/13 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
13.3%
2/15 • Number of events 2 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
0.00%
0/15 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/13 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
|
Skin and subcutaneous tissue disorders
HYPERHIDROSIS
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/13 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/15 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
|
Skin and subcutaneous tissue disorders
NIGHT SWEATS
|
13.3%
2/15 • Number of events 2 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/13 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/15 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
6.7%
1/15 • Number of events 2 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/13 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/15 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
|
Skin and subcutaneous tissue disorders
RASH
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/13 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/15 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
|
Surgical and medical procedures
DENTAL OPERATION
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/13 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/15 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
|
Vascular disorders
FLUSHING
|
66.7%
10/15 • Number of events 10 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
84.6%
11/13 • Number of events 11 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
13.3%
2/15 • Number of events 2 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
|
Vascular disorders
HOT FLUSH
|
13.3%
2/15 • Number of events 2 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
0.00%
0/13 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected during the entire 8 weeks study period (6 weeks of treatment + 2 weeks follow-up after treatment).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PIs may only publish on study results after the main results are published.
- Publication restrictions are in place
Restriction type: OTHER