Trial Outcomes & Findings for Efficacy of Antidepressants in Chronic Back Pain (NCT NCT00964886)
NCT ID: NCT00964886
Last Updated: 2016-11-29
Results Overview
The DDS is self-report measure of "current" pain intensity of chronic back pain. Participants rate pain on a 20 point scale as being greater or less intense relative to 12 adjectival descriptor words which serve as anchors (eg, greater or less than "faint," "moderate," "strong"). Scores range from 0 to 20 with higher scores indicating higher pain intensity. The analysis evaluated the 'as randomized' sample at 12 weeks after baseline or last observation carried forward, after co-varying for baseline (pre-treatment) values.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
142 participants
Primary outcome timeframe
12 weeks after baseline (or last observation carried forward)
Results posted on
2016-11-29
Participant Flow
Participant milestones
| Measure |
Arm 1
desipramine hydrochloride
desipramine hydrochloride: desipramine hydrochloride, with dose targeted to achieve a serum concentration of 5-60ng/ml
|
Arm 2
cognitive behavioral therapy
cognitive behavioral therapy: cognitive behavioral therapy, a type of psychotherapy oriented towards restoring function and reducing impact of pain on everyday life
|
Arm 3
desipramine hydrochloride and cognitive behavioral therapy
desipramine hydrochloride: desipramine hydrochloride, with dose targeted to achieve a serum concentration of 5-60ng/ml
cognitive behavioral therapy: cognitive behavioral therapy, a type of psychotherapy oriented towards restoring function and reducing impact of pain on everyday life
|
Arm 4
anticholinergic medication; active placebo
benztropine mesylate 0.125 mg daily: benztropine mesylate is a placebo, some of whose side effects mimic those of experimental intervention, desipramine hydrochloride
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
38
|
34
|
37
|
33
|
|
Overall Study
COMPLETED
|
27
|
27
|
21
|
24
|
|
Overall Study
NOT COMPLETED
|
11
|
7
|
16
|
9
|
Reasons for withdrawal
| Measure |
Arm 1
desipramine hydrochloride
desipramine hydrochloride: desipramine hydrochloride, with dose targeted to achieve a serum concentration of 5-60ng/ml
|
Arm 2
cognitive behavioral therapy
cognitive behavioral therapy: cognitive behavioral therapy, a type of psychotherapy oriented towards restoring function and reducing impact of pain on everyday life
|
Arm 3
desipramine hydrochloride and cognitive behavioral therapy
desipramine hydrochloride: desipramine hydrochloride, with dose targeted to achieve a serum concentration of 5-60ng/ml
cognitive behavioral therapy: cognitive behavioral therapy, a type of psychotherapy oriented towards restoring function and reducing impact of pain on everyday life
|
Arm 4
anticholinergic medication; active placebo
benztropine mesylate 0.125 mg daily: benztropine mesylate is a placebo, some of whose side effects mimic those of experimental intervention, desipramine hydrochloride
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
6
|
4
|
|
Overall Study
Withdrawal by Subject
|
6
|
2
|
5
|
3
|
|
Overall Study
Adverse Event
|
3
|
1
|
5
|
2
|
|
Overall Study
Protocol Violation
|
0
|
2
|
0
|
0
|
Baseline Characteristics
Gender data missing on one participant.
Baseline characteristics by cohort
| Measure |
Arm 1
n=37 Participants
desipramine hydrochloride
desipramine hydrochloride: desipramine hydrochloride, with dose targeted to achieve a serum concentration of 5-60ng/ml
|
Arm 2
n=33 Participants
cognitive behavioral therapy
cognitive behavioral therapy: cognitive behavioral therapy, a type of psychotherapy oriented towards restoring function and reducing impact of pain on everyday life
|
Arm 3
n=37 Participants
desipramine hydrochloride and cognitive behavioral therapy
desipramine hydrochloride: desipramine hydrochloride, with dose targeted to achieve a serum concentration of 5-60ng/ml
cognitive behavioral therapy: cognitive behavioral therapy, a type of psychotherapy oriented towards restoring function and reducing impact of pain on everyday life
|
Arm 4
n=32 Participants
anticholinergic medication; active placebo
benztropine mesylate 0.125 mg daily: benztropine mesylate is a placebo, some of whose side effects mimic those of experimental intervention, desipramine hydrochloride
|
Total
n=139 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
56.5 years
STANDARD_DEVIATION 11.7 • n=37 Participants
|
57.8 years
STANDARD_DEVIATION 9.2 • n=33 Participants
|
51.5 years
STANDARD_DEVIATION 13.7 • n=37 Participants
|
57.9 years
STANDARD_DEVIATION 10.9 • n=32 Participants
|
55.8 years
STANDARD_DEVIATION 11.7 • n=139 Participants
|
|
Gender
Female
|
5 Participants
n=37 Participants • Gender data missing on one participant.
|
4 Participants
n=33 Participants • Gender data missing on one participant.
|
3 Participants
n=37 Participants • Gender data missing on one participant.
|
3 Participants
n=31 Participants • Gender data missing on one participant.
|
15 Participants
n=138 Participants • Gender data missing on one participant.
|
|
Gender
Male
|
32 Participants
n=37 Participants • Gender data missing on one participant.
|
29 Participants
n=33 Participants • Gender data missing on one participant.
|
34 Participants
n=37 Participants • Gender data missing on one participant.
|
28 Participants
n=31 Participants • Gender data missing on one participant.
|
123 Participants
n=138 Participants • Gender data missing on one participant.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=37 Participants
|
10 Participants
n=33 Participants
|
5 Participants
n=37 Participants
|
4 Participants
n=32 Participants
|
25 Participants
n=139 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=37 Participants
|
22 Participants
n=33 Participants
|
28 Participants
n=37 Participants
|
24 Participants
n=32 Participants
|
103 Participants
n=139 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=37 Participants
|
1 Participants
n=33 Participants
|
4 Participants
n=37 Participants
|
4 Participants
n=32 Participants
|
11 Participants
n=139 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=37 Participants • Data missing on one participant.
|
2 Participants
n=32 Participants • Data missing on one participant.
|
1 Participants
n=37 Participants • Data missing on one participant.
|
0 Participants
n=32 Participants • Data missing on one participant.
|
3 Participants
n=138 Participants • Data missing on one participant.
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=37 Participants • Data missing on one participant.
|
1 Participants
n=32 Participants • Data missing on one participant.
|
2 Participants
n=37 Participants • Data missing on one participant.
|
1 Participants
n=32 Participants • Data missing on one participant.
|
5 Participants
n=138 Participants • Data missing on one participant.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=37 Participants • Data missing on one participant.
|
0 Participants
n=32 Participants • Data missing on one participant.
|
1 Participants
n=37 Participants • Data missing on one participant.
|
1 Participants
n=32 Participants • Data missing on one participant.
|
2 Participants
n=138 Participants • Data missing on one participant.
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=37 Participants • Data missing on one participant.
|
6 Participants
n=32 Participants • Data missing on one participant.
|
4 Participants
n=37 Participants • Data missing on one participant.
|
5 Participants
n=32 Participants • Data missing on one participant.
|
21 Participants
n=138 Participants • Data missing on one participant.
|
|
Race (NIH/OMB)
White
|
25 Participants
n=37 Participants • Data missing on one participant.
|
18 Participants
n=32 Participants • Data missing on one participant.
|
21 Participants
n=37 Participants • Data missing on one participant.
|
20 Participants
n=32 Participants • Data missing on one participant.
|
84 Participants
n=138 Participants • Data missing on one participant.
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=37 Participants • Data missing on one participant.
|
2 Participants
n=32 Participants • Data missing on one participant.
|
7 Participants
n=37 Participants • Data missing on one participant.
|
3 Participants
n=32 Participants • Data missing on one participant.
|
16 Participants
n=138 Participants • Data missing on one participant.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=37 Participants • Data missing on one participant.
|
3 Participants
n=32 Participants • Data missing on one participant.
|
1 Participants
n=37 Participants • Data missing on one participant.
|
2 Participants
n=32 Participants • Data missing on one participant.
|
7 Participants
n=138 Participants • Data missing on one participant.
|
|
Region of Enrollment
United States
|
37 participants
n=37 Participants
|
33 participants
n=33 Participants
|
37 participants
n=37 Participants
|
32 participants
n=32 Participants
|
139 participants
n=139 Participants
|
|
Pain Intensity and Back Pain Disability
Pain Intensity (Descriptor Differential Scale)
|
9.9 units on a scale
STANDARD_DEVIATION 4.9 • n=37 Participants
|
11.9 units on a scale
STANDARD_DEVIATION 4.3 • n=33 Participants
|
11.9 units on a scale
STANDARD_DEVIATION 5.1 • n=37 Participants
|
12.1 units on a scale
STANDARD_DEVIATION 4.6 • n=32 Participants
|
11.4 units on a scale
STANDARD_DEVIATION 4.0 • n=139 Participants
|
|
Pain Intensity and Back Pain Disability
Back Pain Disability (Roland and Morris)
|
8.7 units on a scale
STANDARD_DEVIATION 5.4 • n=37 Participants
|
13.0 units on a scale
STANDARD_DEVIATION 4.3 • n=33 Participants
|
11.7 units on a scale
STANDARD_DEVIATION 5.4 • n=37 Participants
|
12.6 units on a scale
STANDARD_DEVIATION 3.8 • n=32 Participants
|
11.8 units on a scale
STANDARD_DEVIATION 4.9 • n=139 Participants
|
PRIMARY outcome
Timeframe: 12 weeks after baseline (or last observation carried forward)Population: We conducted an intent-to-treat analysis of all randomized participants assigned to desipramine or to active drug placebo (benztropine) comparing mean DDS pain intensity at Week 12 (or the last observation carried forward) adjusted for mean baseline score.
The DDS is self-report measure of "current" pain intensity of chronic back pain. Participants rate pain on a 20 point scale as being greater or less intense relative to 12 adjectival descriptor words which serve as anchors (eg, greater or less than "faint," "moderate," "strong"). Scores range from 0 to 20 with higher scores indicating higher pain intensity. The analysis evaluated the 'as randomized' sample at 12 weeks after baseline or last observation carried forward, after co-varying for baseline (pre-treatment) values.
Outcome measures
| Measure |
Arm 1 + Arm 3
n=75 Participants
Factor desipramine hydrochloride
desipramine hydrochloride: desipramine hydrochloride, with dose targeted to achieve a serum concentration of 5-60ng/ml
|
Arm 2 + Arm 4
n=67 Participants
Factor anticholinergic medication; active placebo
benztropine mesylate 0.125 mg daily: benztropine mesylate is a placebo, some of whose side effects mimic those of experimental intervention, desipramine hydrochloride
|
|---|---|---|
|
Intent-toTreat Analysis of Descriptor Differential Scale (DDS) of Pain Intensity
|
8.3 units on a scale
Standard Error 0.5
|
8.1 units on a scale
Standard Error 0.6
|
PRIMARY outcome
Timeframe: 12 weeks after baseline (or last observation carried forward)Population: We conducted an intent-to-treat analysis of all randomized participants assigned to cognitive behavioral therapy to or no behavior therapy comparing mean DDS pain intensity at Week 12 (or the last observation carried forward) adjusted for mean baseline score.
The DDS is self-report measure of "current" pain intensity of chronic back pain. Participants rate pain on a 20 point scale as being greater or less intense relative to 12 adjectival descriptor words which serve as anchors (eg, greater or less than "faint," "moderate," "strong"). Scores range from 0 to 20 with higher scores indicating higher pain intensity. The analysis evaluated the 'as randomized' sample at 12 weeks after baseline or last observation carried forward, after co-varying for baseline (pre-treatment) values.
Outcome measures
| Measure |
Arm 1 + Arm 3
n=71 Participants
Factor desipramine hydrochloride
desipramine hydrochloride: desipramine hydrochloride, with dose targeted to achieve a serum concentration of 5-60ng/ml
|
Arm 2 + Arm 4
n=71 Participants
Factor anticholinergic medication; active placebo
benztropine mesylate 0.125 mg daily: benztropine mesylate is a placebo, some of whose side effects mimic those of experimental intervention, desipramine hydrochloride
|
|---|---|---|
|
Intent-toTreat Analysis of Descriptor Differential Scale (DDS) of Pain Intensity
|
8.0 units on a scale
Standard Error 0.6
|
8.4 units on a scale
Standard Error 0.6
|
SECONDARY outcome
Timeframe: 12 weeks after baseline (or last observation carried forward)Population: All participants assigned at baseline to receive desipramine hydrochloride or benztropine mesylate (drug effect). This is an 'as randomized' Intent-to-Treat analysis. Values are mean scores at Week 12 (or last observation carried forward). Means are adjusted for baseline Roland and Morris scores
This questionnaire measures disability in everyday function due to back pain. It is a 24-item checklist asking patients to endorse whether or not back pain limits activities they normally do (eg, "I stay at home most of the time because of my back"). Scores range from 0 to 24, with higher scores indicating greater disability in everyday function due to back pain. The analysis evaluated the 'as randomized' sample at 12 weeks after baseline, after co-varying for baseline (pre-treatment) values.
Outcome measures
| Measure |
Arm 1 + Arm 3
n=75 Participants
Factor desipramine hydrochloride
desipramine hydrochloride: desipramine hydrochloride, with dose targeted to achieve a serum concentration of 5-60ng/ml
|
Arm 2 + Arm 4
n=67 Participants
Factor anticholinergic medication; active placebo
benztropine mesylate 0.125 mg daily: benztropine mesylate is a placebo, some of whose side effects mimic those of experimental intervention, desipramine hydrochloride
|
|---|---|---|
|
Roland and Morris Disability Questionnaire
|
8.7 Units on a scale.
Standard Error 0.5
|
8.9 Units on a scale.
Standard Error 0.5
|
SECONDARY outcome
Timeframe: 12 weeks after baseline (or last observation carried forward)Population: All participants assigned at baseline to receive cognitive behavioral therapy or to no cognitive behavioral therapy (behavioral effect). This is an 'as randomized' Intent-to-Treat analysis. Values are mean scores at Week 12 (or last observation carried forward). Means are adjusted for baseline Roland and Morris scores
This questionnaire measures disability in everyday function due to back pain. It is a 24-item checklist asking patients to endorse whether or not back pain limits activities they normally do (eg, "I stay at home most of the time because of my back"). Scores range from 0 to 24, with higher scores indicating greater disability in everyday function due to back pain. The analysis evaluated the 'as randomized' sample at 12 weeks after baseline, after co-varying for baseline (pre-treatment) values.
Outcome measures
| Measure |
Arm 1 + Arm 3
n=71 Participants
Factor desipramine hydrochloride
desipramine hydrochloride: desipramine hydrochloride, with dose targeted to achieve a serum concentration of 5-60ng/ml
|
Arm 2 + Arm 4
n=71 Participants
Factor anticholinergic medication; active placebo
benztropine mesylate 0.125 mg daily: benztropine mesylate is a placebo, some of whose side effects mimic those of experimental intervention, desipramine hydrochloride
|
|---|---|---|
|
Roland and Morris Disability Questionnaire
|
8.7 Units on a scale.
Standard Error 0.5
|
8.9 Units on a scale.
Standard Error 0.5
|
Adverse Events
Arm 1
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Arm 2
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Arm 3
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Arm 4
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1
n=17 participants at risk；n=38 participants at risk
desipramine hydrochloride
desipramine hydrochloride: desipramine hydrochloride, with dose targeted to achieve a serum concentration of 5-60ng/ml
|
Arm 2
n=20 participants at risk；n=34 participants at risk
cognitive behavioral therapy
cognitive behavioral therapy: cognitive behavioral therapy, a type of psychotherapy oriented towards restoring function and reducing impact of pain on everyday life
|
Arm 3
n=16 participants at risk；n=37 participants at risk
desipramine hydrochloride and cognitive behavioral therapy
desipramine hydrochloride: desipramine hydrochloride, with dose targeted to achieve a serum concentration of 5-60ng/ml
cognitive behavioral therapy: cognitive behavioral therapy, a type of psychotherapy oriented towards restoring function and reducing impact of pain on everyday life
|
Arm 4
n=17 participants at risk；n=33 participants at risk
anticholinergic medication; active placebo
benztropine mesylate 0.125 mg daily: benztropine mesylate is a placebo, some of whose side effects mimic those of experimental intervention, desipramine hydrochloride
|
|---|---|---|---|---|
|
Renal and urinary disorders
urosepsis
|
2.6%
1/38 • Number of events 1 • Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Non-serious adverse advents were monitored for 70 participants.
|
0.00%
0/34 • Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Non-serious adverse advents were monitored for 70 participants.
|
0.00%
0/37 • Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Non-serious adverse advents were monitored for 70 participants.
|
0.00%
0/33 • Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Non-serious adverse advents were monitored for 70 participants.
|
|
Cardiac disorders
fall
|
0.00%
0/38 • Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Non-serious adverse advents were monitored for 70 participants.
|
0.00%
0/34 • Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Non-serious adverse advents were monitored for 70 participants.
|
2.7%
1/37 • Number of events 1 • Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Non-serious adverse advents were monitored for 70 participants.
|
0.00%
0/33 • Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Non-serious adverse advents were monitored for 70 participants.
|
Other adverse events
| Measure |
Arm 1
n=17 participants at risk；n=38 participants at risk
desipramine hydrochloride
desipramine hydrochloride: desipramine hydrochloride, with dose targeted to achieve a serum concentration of 5-60ng/ml
|
Arm 2
n=20 participants at risk；n=34 participants at risk
cognitive behavioral therapy
cognitive behavioral therapy: cognitive behavioral therapy, a type of psychotherapy oriented towards restoring function and reducing impact of pain on everyday life
|
Arm 3
n=16 participants at risk；n=37 participants at risk
desipramine hydrochloride and cognitive behavioral therapy
desipramine hydrochloride: desipramine hydrochloride, with dose targeted to achieve a serum concentration of 5-60ng/ml
cognitive behavioral therapy: cognitive behavioral therapy, a type of psychotherapy oriented towards restoring function and reducing impact of pain on everyday life
|
Arm 4
n=17 participants at risk；n=33 participants at risk
anticholinergic medication; active placebo
benztropine mesylate 0.125 mg daily: benztropine mesylate is a placebo, some of whose side effects mimic those of experimental intervention, desipramine hydrochloride
|
|---|---|---|---|---|
|
Eye disorders
accomodation disturbance
|
11.8%
2/17 • Number of events 2 • Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Non-serious adverse advents were monitored for 70 participants.
|
0.00%
0/20 • Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Non-serious adverse advents were monitored for 70 participants.
|
12.5%
2/16 • Number of events 2 • Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Non-serious adverse advents were monitored for 70 participants.
|
5.9%
1/17 • Number of events 1 • Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Non-serious adverse advents were monitored for 70 participants.
|
|
Nervous system disorders
decreased libido
|
5.9%
1/17 • Number of events 1 • Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Non-serious adverse advents were monitored for 70 participants.
|
0.00%
0/20 • Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Non-serious adverse advents were monitored for 70 participants.
|
0.00%
0/16 • Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Non-serious adverse advents were monitored for 70 participants.
|
17.6%
3/17 • Number of events 3 • Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Non-serious adverse advents were monitored for 70 participants.
|
|
Nervous system disorders
increased dreaming
|
5.9%
1/17 • Number of events 1 • Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Non-serious adverse advents were monitored for 70 participants.
|
10.0%
2/20 • Number of events 2 • Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Non-serious adverse advents were monitored for 70 participants.
|
0.00%
0/16 • Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Non-serious adverse advents were monitored for 70 participants.
|
5.9%
1/17 • Number of events 1 • Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Non-serious adverse advents were monitored for 70 participants.
|
|
Nervous system disorders
sedation
|
0.00%
0/17 • Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Non-serious adverse advents were monitored for 70 participants.
|
5.0%
1/20 • Number of events 1 • Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Non-serious adverse advents were monitored for 70 participants.
|
12.5%
2/16 • Number of events 2 • Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Non-serious adverse advents were monitored for 70 participants.
|
0.00%
0/17 • Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Non-serious adverse advents were monitored for 70 participants.
|
|
Nervous system disorders
increased sleep duration
|
0.00%
0/17 • Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Non-serious adverse advents were monitored for 70 participants.
|
10.0%
2/20 • Number of events 2 • Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Non-serious adverse advents were monitored for 70 participants.
|
6.2%
1/16 • Number of events 1 • Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Non-serious adverse advents were monitored for 70 participants.
|
0.00%
0/17 • Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Non-serious adverse advents were monitored for 70 participants.
|
|
Gastrointestinal disorders
dry mouth
|
29.4%
5/17 • Number of events 5 • Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Non-serious adverse advents were monitored for 70 participants.
|
15.0%
3/20 • Number of events 3 • Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Non-serious adverse advents were monitored for 70 participants.
|
25.0%
4/16 • Number of events 4 • Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Non-serious adverse advents were monitored for 70 participants.
|
5.9%
1/17 • Number of events 1 • Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Non-serious adverse advents were monitored for 70 participants.
|
|
Renal and urinary disorders
difficulty urinating
|
23.5%
4/17 • Number of events 4 • Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Non-serious adverse advents were monitored for 70 participants.
|
5.0%
1/20 • Number of events 1 • Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Non-serious adverse advents were monitored for 70 participants.
|
6.2%
1/16 • Number of events 1 • Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Non-serious adverse advents were monitored for 70 participants.
|
5.9%
1/17 • Number of events 1 • Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Non-serious adverse advents were monitored for 70 participants.
|
|
Gastrointestinal disorders
constipation
|
23.5%
4/17 • Number of events 4 • Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Non-serious adverse advents were monitored for 70 participants.
|
5.0%
1/20 • Number of events 1 • Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Non-serious adverse advents were monitored for 70 participants.
|
6.2%
1/16 • Number of events 1 • Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Non-serious adverse advents were monitored for 70 participants.
|
5.9%
1/17 • Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Non-serious adverse advents were monitored for 70 participants.
|
|
Renal and urinary disorders
erectile dysfunction
|
17.6%
3/17 • Number of events 3 • Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Non-serious adverse advents were monitored for 70 participants.
|
0.00%
0/20 • Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Non-serious adverse advents were monitored for 70 participants.
|
0.00%
0/16 • Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Non-serious adverse advents were monitored for 70 participants.
|
17.6%
3/17 • Number of events 3 • Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Non-serious adverse advents were monitored for 70 participants.
|
|
Renal and urinary disorders
ejaculatory dysfunction
|
11.8%
2/17 • Number of events 2 • Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Non-serious adverse advents were monitored for 70 participants.
|
0.00%
0/20 • Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Non-serious adverse advents were monitored for 70 participants.
|
0.00%
0/16 • Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Non-serious adverse advents were monitored for 70 participants.
|
5.9%
1/17 • Number of events 1 • Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Non-serious adverse advents were monitored for 70 participants.
|
|
Renal and urinary disorders
orgasm dysfunction
|
11.8%
2/17 • Number of events 2 • Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Non-serious adverse advents were monitored for 70 participants.
|
0.00%
0/20 • Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Non-serious adverse advents were monitored for 70 participants.
|
0.00%
0/16 • Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Non-serious adverse advents were monitored for 70 participants.
|
5.9%
1/17 • Number of events 1 • Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Non-serious adverse advents were monitored for 70 participants.
|
|
Nervous system disorders
asthenia
|
0.00%
0/17 • Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Non-serious adverse advents were monitored for 70 participants.
|
5.0%
1/20 • Number of events 1 • Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Non-serious adverse advents were monitored for 70 participants.
|
0.00%
0/16 • Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Non-serious adverse advents were monitored for 70 participants.
|
5.9%
1/17 • Number of events 1 • Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Non-serious adverse advents were monitored for 70 participants.
|
|
General disorders
diaphoresis
|
5.9%
1/17 • Number of events 1 • Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Non-serious adverse advents were monitored for 70 participants.
|
5.0%
1/20 • Number of events 1 • Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Non-serious adverse advents were monitored for 70 participants.
|
0.00%
0/16 • Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Non-serious adverse advents were monitored for 70 participants.
|
0.00%
0/17 • Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Non-serious adverse advents were monitored for 70 participants.
|
|
Nervous system disorders
muscle rigidity
|
5.9%
1/17 • Number of events 1 • Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Non-serious adverse advents were monitored for 70 participants.
|
5.0%
1/20 • Number of events 1 • Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Non-serious adverse advents were monitored for 70 participants.
|
0.00%
0/16 • Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Non-serious adverse advents were monitored for 70 participants.
|
0.00%
0/17 • Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Non-serious adverse advents were monitored for 70 participants.
|
|
Nervous system disorders
hyperkinesis
|
0.00%
0/17 • Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Non-serious adverse advents were monitored for 70 participants.
|
5.0%
1/20 • Number of events 1 • Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Non-serious adverse advents were monitored for 70 participants.
|
0.00%
0/16 • Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Non-serious adverse advents were monitored for 70 participants.
|
5.9%
1/17 • Number of events 1 • Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Non-serious adverse advents were monitored for 70 participants.
|
|
Psychiatric disorders
depression
|
0.00%
0/17 • Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Non-serious adverse advents were monitored for 70 participants.
|
0.00%
0/20 • Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Non-serious adverse advents were monitored for 70 participants.
|
0.00%
0/16 • Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Non-serious adverse advents were monitored for 70 participants.
|
5.9%
1/17 • Number of events 1 • Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Non-serious adverse advents were monitored for 70 participants.
|
|
Nervous system disorders
dystonia
|
0.00%
0/17 • Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Non-serious adverse advents were monitored for 70 participants.
|
5.0%
1/20 • Number of events 1 • Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Non-serious adverse advents were monitored for 70 participants.
|
0.00%
0/16 • Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Non-serious adverse advents were monitored for 70 participants.
|
0.00%
0/17 • Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Non-serious adverse advents were monitored for 70 participants.
|
|
Nervous system disorders
dysarthria
|
0.00%
0/17 • Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Non-serious adverse advents were monitored for 70 participants.
|
0.00%
0/20 • Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Non-serious adverse advents were monitored for 70 participants.
|
0.00%
0/16 • Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Non-serious adverse advents were monitored for 70 participants.
|
5.9%
1/17 • Number of events 1 • Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Non-serious adverse advents were monitored for 70 participants.
|
|
Nervous system disorders
ataxia
|
0.00%
0/17 • Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Non-serious adverse advents were monitored for 70 participants.
|
0.00%
0/20 • Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Non-serious adverse advents were monitored for 70 participants.
|
0.00%
0/16 • Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Non-serious adverse advents were monitored for 70 participants.
|
5.9%
1/17 • Number of events 1 • Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Non-serious adverse advents were monitored for 70 participants.
|
|
Endocrine disorders
gynecomastia
|
0.00%
0/17 • Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Non-serious adverse advents were monitored for 70 participants.
|
5.0%
1/20 • Number of events 1 • Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Non-serious adverse advents were monitored for 70 participants.
|
0.00%
0/16 • Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Non-serious adverse advents were monitored for 70 participants.
|
0.00%
0/17 • Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Non-serious adverse advents were monitored for 70 participants.
|
|
Nervous system disorders
insomnia
|
5.9%
1/17 • Number of events 1 • Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Non-serious adverse advents were monitored for 70 participants.
|
0.00%
0/20 • Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Non-serious adverse advents were monitored for 70 participants.
|
0.00%
0/16 • Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Non-serious adverse advents were monitored for 70 participants.
|
0.00%
0/17 • Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Non-serious adverse advents were monitored for 70 participants.
|
|
General disorders
nausea
|
0.00%
0/17 • Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Non-serious adverse advents were monitored for 70 participants.
|
0.00%
0/20 • Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Non-serious adverse advents were monitored for 70 participants.
|
0.00%
0/16 • Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Non-serious adverse advents were monitored for 70 participants.
|
5.9%
1/17 • Number of events 1 • Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Non-serious adverse advents were monitored for 70 participants.
|
|
General disorders
photosensitivity
|
5.9%
1/17 • Number of events 1 • Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Non-serious adverse advents were monitored for 70 participants.
|
0.00%
0/20 • Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Non-serious adverse advents were monitored for 70 participants.
|
0.00%
0/16 • Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Non-serious adverse advents were monitored for 70 participants.
|
0.00%
0/17 • Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Non-serious adverse advents were monitored for 70 participants.
|
|
Nervous system disorders
paresthesia
|
0.00%
0/17 • Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Non-serious adverse advents were monitored for 70 participants.
|
5.0%
1/20 • Number of events 1 • Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Non-serious adverse advents were monitored for 70 participants.
|
0.00%
0/16 • Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Non-serious adverse advents were monitored for 70 participants.
|
0.00%
0/17 • Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Non-serious adverse advents were monitored for 70 participants.
|
|
Renal and urinary disorders
polyuria
|
0.00%
0/17 • Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Non-serious adverse advents were monitored for 70 participants.
|
0.00%
0/20 • Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Non-serious adverse advents were monitored for 70 participants.
|
0.00%
0/16 • Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Non-serious adverse advents were monitored for 70 participants.
|
5.9%
1/17 • Number of events 1 • Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Non-serious adverse advents were monitored for 70 participants.
|
|
Endocrine disorders
weight gain
|
0.00%
0/17 • Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Non-serious adverse advents were monitored for 70 participants.
|
5.0%
1/20 • Number of events 1 • Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Non-serious adverse advents were monitored for 70 participants.
|
0.00%
0/16 • Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Non-serious adverse advents were monitored for 70 participants.
|
0.00%
0/17 • Report of side effects experienced within the past 3 days by participants completing the Week 12 visit.
Non-serious adverse advents were monitored for 70 participants.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place