Trial Outcomes & Findings for Evaluation of Moclobemide, a Reversible MAO-A Inhibitor, as an Adjunct to Nicotine Replacement Therapy in Female Smokers (NCT NCT01926626)
NCT ID: NCT01926626
Last Updated: 2017-08-23
Results Overview
Number of participants who reported continuous four-week abstinence from smoking (weeks 6-10 post target quit date), confirmed by expired air carbon monoxide (CO).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
76 participants
Primary outcome timeframe
Weeks 6-10 post quit day
Results posted on
2017-08-23
Participant Flow
Of the 76 participants who were enrolled, 38 participants attended Study Session 1: 1 participant voluntarily withdrew prior to Study Session 1, 3 participants were lost to contact prior to Study Session 1, and 34 were withdrawn from the study by the PI or medical staff because they did not meet inclusion criteria or met exclusion criteria.
Participant milestones
| Measure |
Nicotine Patch+Moclobemide
After 1 week of pre-cessation nicotine patch treatment (21 mg/24 h patches), participants will receive moclobemide (400 mg/day in 2 divided doses) for 11 weeks, ending 10 weeks after the target quit date. Nicotine patch treatment will continue at 21 mg/24 h for an additional week prior to the quit date, and then for 6 weeks after the quit date, followed by 14 mg/24 h for 2 weeks and 7 mg/24 h for 2 weeks. All treatment will terminate 10 weeks after the quit date.
Nicotine Patch: Pre-Quit Period: 2 weeks of patch use (21mg/24hr)
Post Quit Period: 10 weeks of patch use (21mg/24hr for 6 weeks, 14mg/24hr for 2 weeks, and 7mg/24hr for 2 weeks)
Moclobemide: Pre-Quit Period: 1 week of moclobemide use (400 mg/day in 2 divided doses)
Post Quit Period: 10 weeks of moclobemide use (400 mg/day in 2 divided doses)
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|---|---|
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Overall Study
STARTED
|
38
|
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Overall Study
Received Moclobemide
|
37
|
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Overall Study
COMPLETED
|
16
|
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Overall Study
NOT COMPLETED
|
22
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Reasons for withdrawal
| Measure |
Nicotine Patch+Moclobemide
After 1 week of pre-cessation nicotine patch treatment (21 mg/24 h patches), participants will receive moclobemide (400 mg/day in 2 divided doses) for 11 weeks, ending 10 weeks after the target quit date. Nicotine patch treatment will continue at 21 mg/24 h for an additional week prior to the quit date, and then for 6 weeks after the quit date, followed by 14 mg/24 h for 2 weeks and 7 mg/24 h for 2 weeks. All treatment will terminate 10 weeks after the quit date.
Nicotine Patch: Pre-Quit Period: 2 weeks of patch use (21mg/24hr)
Post Quit Period: 10 weeks of patch use (21mg/24hr for 6 weeks, 14mg/24hr for 2 weeks, and 7mg/24hr for 2 weeks)
Moclobemide: Pre-Quit Period: 1 week of moclobemide use (400 mg/day in 2 divided doses)
Post Quit Period: 10 weeks of moclobemide use (400 mg/day in 2 divided doses)
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|---|---|
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Overall Study
Withdrawal by Subject
|
15
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Overall Study
Lost to Follow-up
|
7
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Baseline Characteristics
Evaluation of Moclobemide, a Reversible MAO-A Inhibitor, as an Adjunct to Nicotine Replacement Therapy in Female Smokers
Baseline characteristics by cohort
| Measure |
Nicotine Patch+Moclobemide
n=38 Participants
After 1 week of pre-cessation nicotine patch treatment (21 mg/24 h patches), participants will receive moclobemide (400 mg/day in 2 divided doses) for 11 weeks, ending 10 weeks after the target quit date. Nicotine patch treatment will continue at 21 mg/24 h for an additional week prior to the quit date, and then for 6 weeks after the quit date, followed by 14 mg/24 h for 2 weeks and 7 mg/24 h for 2 weeks. All treatment will terminate 10 weeks after the quit date.
Nicotine Patch: Pre-Quit Period: 2 weeks of patch use (21mg/24hr)
Post Quit Period: 10 weeks of patch use (21mg/24hr for 6 weeks, 14mg/24hr for 2 weeks, and 7mg/24hr for 2 weeks)
Moclobemide: Pre-Quit Period: 1 week of moclobemide use (400 mg/day in 2 divided doses)
Post Quit Period: 10 weeks of moclobemide use (400 mg/day in 2 divided doses)
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=99 Participants
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|
Age, Categorical
Between 18 and 65 years
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38 Participants
n=99 Participants
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Age, Categorical
>=65 years
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0 Participants
n=99 Participants
|
|
Age, Continuous
|
46.53 years
STANDARD_DEVIATION 9.86 • n=99 Participants
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Sex: Female, Male
Female
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38 Participants
n=99 Participants
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Sex: Female, Male
Male
|
0 Participants
n=99 Participants
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Region of Enrollment
United States
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38 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Weeks 6-10 post quit dayNumber of participants who reported continuous four-week abstinence from smoking (weeks 6-10 post target quit date), confirmed by expired air carbon monoxide (CO).
Outcome measures
| Measure |
Nicotine Patch+Moclobemide
n=38 Participants
After 1 week of pre-cessation nicotine patch treatment (21 mg/24 h patches), participants will receive moclobemide (400 mg/day in 2 divided doses) for 11 weeks, ending 10 weeks after the target quit date. Nicotine patch treatment will continue at 21 mg/24 h for an additional week prior to the quit date, and then for 6 weeks after the quit date, followed by 14 mg/24 h for 2 weeks and 7 mg/24 h for 2 weeks. All treatment will terminate 10 weeks after the quit date.
Nicotine Patch: Pre-Quit Period: 2 weeks of patch use (21mg/24hr)
Post Quit Period: 10 weeks of patch use (21mg/24hr for 6 weeks, 14mg/24hr for 2 weeks, and 7mg/24hr for 2 weeks)
Moclobemide: Pre-Quit Period: 1 week of moclobemide use (400 mg/day in 2 divided doses)
Post Quit Period: 10 weeks of moclobemide use (400 mg/day in 2 divided doses)
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|---|---|
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Continuous Four-week Abstinence From Smoking
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7 participants
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SECONDARY outcome
Timeframe: 7 day point abstinence from smoking at six months post quitNumber of participants who reported 7-day point abstinence from smoking at six months post quit, confirmed by expired air CO.
Outcome measures
| Measure |
Nicotine Patch+Moclobemide
n=38 Participants
After 1 week of pre-cessation nicotine patch treatment (21 mg/24 h patches), participants will receive moclobemide (400 mg/day in 2 divided doses) for 11 weeks, ending 10 weeks after the target quit date. Nicotine patch treatment will continue at 21 mg/24 h for an additional week prior to the quit date, and then for 6 weeks after the quit date, followed by 14 mg/24 h for 2 weeks and 7 mg/24 h for 2 weeks. All treatment will terminate 10 weeks after the quit date.
Nicotine Patch: Pre-Quit Period: 2 weeks of patch use (21mg/24hr)
Post Quit Period: 10 weeks of patch use (21mg/24hr for 6 weeks, 14mg/24hr for 2 weeks, and 7mg/24hr for 2 weeks)
Moclobemide: Pre-Quit Period: 1 week of moclobemide use (400 mg/day in 2 divided doses)
Post Quit Period: 10 weeks of moclobemide use (400 mg/day in 2 divided doses)
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|---|---|
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Point Abstinence From Smoking at Six Months Post Quit
|
2 participants
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SECONDARY outcome
Timeframe: 10 weeks post quit dayNumber of participants who reported continuous ten-week abstinence from smoking (weeks 1-10 post quit day), confirmed by expired air CO.
Outcome measures
| Measure |
Nicotine Patch+Moclobemide
n=38 Participants
After 1 week of pre-cessation nicotine patch treatment (21 mg/24 h patches), participants will receive moclobemide (400 mg/day in 2 divided doses) for 11 weeks, ending 10 weeks after the target quit date. Nicotine patch treatment will continue at 21 mg/24 h for an additional week prior to the quit date, and then for 6 weeks after the quit date, followed by 14 mg/24 h for 2 weeks and 7 mg/24 h for 2 weeks. All treatment will terminate 10 weeks after the quit date.
Nicotine Patch: Pre-Quit Period: 2 weeks of patch use (21mg/24hr)
Post Quit Period: 10 weeks of patch use (21mg/24hr for 6 weeks, 14mg/24hr for 2 weeks, and 7mg/24hr for 2 weeks)
Moclobemide: Pre-Quit Period: 1 week of moclobemide use (400 mg/day in 2 divided doses)
Post Quit Period: 10 weeks of moclobemide use (400 mg/day in 2 divided doses)
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|---|---|
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Continuous Ten Week Abstinence From Smoking
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4 participants
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SECONDARY outcome
Timeframe: Quit day and 1 week, 3 weeks, 6 weeks, 10 weeks and 6 months post quit dayWithdrawal symptoms will be assessed by questionnaire on Quit Day, 1 week post quit, 3 weeks post quit, 6 weeks post quit,10 weeks post quit and 6 months post quit (if applicable) using the Shiffman-Jarvik questionnaire, which consists of 33-items rated from 1 to 7, where 1= not at all, 2= very little, 3= a little, 4= moderately, 5= a lot, 6= quite a lot, and 7= extremely. The 33 items are grouped into 8 subscales: Craving, Negative Affect, Appetite, Arousal, Somatic - Anxiety, Somatic - G.I., Somatic - Respiratory Tract, and Habit Withdrawal. The range of scores for each subscale will be 1-7, with higher scores indicating more of the withdrawal symptom having been experienced.
Outcome measures
| Measure |
Nicotine Patch+Moclobemide
n=38 Participants
After 1 week of pre-cessation nicotine patch treatment (21 mg/24 h patches), participants will receive moclobemide (400 mg/day in 2 divided doses) for 11 weeks, ending 10 weeks after the target quit date. Nicotine patch treatment will continue at 21 mg/24 h for an additional week prior to the quit date, and then for 6 weeks after the quit date, followed by 14 mg/24 h for 2 weeks and 7 mg/24 h for 2 weeks. All treatment will terminate 10 weeks after the quit date.
Nicotine Patch: Pre-Quit Period: 2 weeks of patch use (21mg/24hr)
Post Quit Period: 10 weeks of patch use (21mg/24hr for 6 weeks, 14mg/24hr for 2 weeks, and 7mg/24hr for 2 weeks)
Moclobemide: Pre-Quit Period: 1 week of moclobemide use (400 mg/day in 2 divided doses)
Post Quit Period: 10 weeks of moclobemide use (400 mg/day in 2 divided doses)
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|---|---|
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Percentage of Change in Smoking Withdrawal Symptoms
Craving -- % change 6 weeks from Quit Day
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-14.24 percentage of change
Standard Error 4.63
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|
Percentage of Change in Smoking Withdrawal Symptoms
Craving -- % change 6 months from Quit Day
|
23.71 percentage of change
Standard Error 63.690
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|
Percentage of Change in Smoking Withdrawal Symptoms
Negative Affect -- % change 6 months from Quit Day
|
48.87 percentage of change
Standard Error 65.334
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Percentage of Change in Smoking Withdrawal Symptoms
Appetite -- % change 1 week from Quit Day
|
-11.40 percentage of change
Standard Error 5.486
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Percentage of Change in Smoking Withdrawal Symptoms
Appetite -- % change 3 weeks from Quit Day
|
-4.39 percentage of change
Standard Error 7.881
|
|
Percentage of Change in Smoking Withdrawal Symptoms
Appetite -- % change 6 months from Quit Day
|
27.24 percentage of change
Standard Error 74.446
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Percentage of Change in Smoking Withdrawal Symptoms
Arousal -- % change 10 weeks from Quit Day
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18.95 percentage of change
Standard Error 6.715
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Percentage of Change in Smoking Withdrawal Symptoms
Gastrointestinal -- % change 1 week from Quit Day
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-5.80 percentage of change
Standard Error 3.365
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Percentage of Change in Smoking Withdrawal Symptoms
Respiratory -- % change 6 months from Quit Day
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-38.79 percentage of change
Standard Error 19.553
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Percentage of Change in Smoking Withdrawal Symptoms
Habit -- % change 1 week from Quit Day
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-9.26 percentage of change
Standard Error 7.272
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Percentage of Change in Smoking Withdrawal Symptoms
Craving -- % change 1 week from Quit Day
|
-8.07 percentage of change
Standard Error 7.928
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Percentage of Change in Smoking Withdrawal Symptoms
Craving -- % change 3 weeks from Quit Day
|
-13.18 percentage of change
Standard Error 4.144
|
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Percentage of Change in Smoking Withdrawal Symptoms
Craving -- % change 10 weeks from Quit Day
|
-13.41 percentage of change
Standard Error 6.912
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|
Percentage of Change in Smoking Withdrawal Symptoms
Negative Affect -- % change 1 week from Quit Day
|
-22.82 percentage of change
Standard Error 4.057
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|
Percentage of Change in Smoking Withdrawal Symptoms
Negative Affect -- % change 3 weeks from Quit Day
|
-14.26 percentage of change
Standard Error 4.327
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Percentage of Change in Smoking Withdrawal Symptoms
Negative Affect -- % change 6 weeks from Quit Day
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-21.53 percentage of change
Standard Error 4.051
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|
Percentage of Change in Smoking Withdrawal Symptoms
Negative Affect -- % change 10 weeks from Quit Day
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-13.92 percentage of change
Standard Error 4.968
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Percentage of Change in Smoking Withdrawal Symptoms
Appetite -- % change 6 weeks from Quit Day
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-17.07 percentage of change
Standard Error 8.819
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|
Percentage of Change in Smoking Withdrawal Symptoms
Appetite -- % change 10 weeks from Quit Day
|
0.73 percentage of change
Standard Error 16.033
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|
Percentage of Change in Smoking Withdrawal Symptoms
Arousal -- % change 1 week from Quit Day
|
29.81 percentage of change
Standard Error 8.824
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Percentage of Change in Smoking Withdrawal Symptoms
Arousal -- % change 3 weeks from Quit Day
|
29.03 percentage of change
Standard Error 7.004
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Percentage of Change in Smoking Withdrawal Symptoms
Arousal -- % change 6 weeks from Quit Day
|
29.99 percentage of change
Standard Error 6.915
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Percentage of Change in Smoking Withdrawal Symptoms
Arousal -- % change 6 months from Quit Day
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190.88 percentage of change
Standard Error 78.496
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Percentage of Change in Smoking Withdrawal Symptoms
Anxiety -- % change 1 week from Quit Day
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-4.65 percentage of change
Standard Error 3.803
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Percentage of Change in Smoking Withdrawal Symptoms
Anxiety -- % change 3 weeks from Quit Day
|
-5.80 percentage of change
Standard Error 4.788
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Percentage of Change in Smoking Withdrawal Symptoms
Anxiety -- % change 6 weeks from Quit Day
|
-4.48 percentage of change
Standard Error 5.098
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|
Percentage of Change in Smoking Withdrawal Symptoms
Anxiety -- % change 10 weeks from Quit Day
|
-9.44 percentage of change
Standard Error 6.375
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Percentage of Change in Smoking Withdrawal Symptoms
Anxiety -- % change 6 months from Quit Day
|
-38.79 percentage of change
Standard Error 19.553
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|
Percentage of Change in Smoking Withdrawal Symptoms
Gastrointestinal -- % change 3 weeks from Quit Day
|
-2.03 percentage of change
Standard Error 6.602
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Percentage of Change in Smoking Withdrawal Symptoms
Gastrointestinal -- % change 6 weeks from Quit Day
|
4.55 percentage of change
Standard Error 16.189
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Percentage of Change in Smoking Withdrawal Symptoms
Gastrointestinal - % change 10 weeks from Quit Day
|
-12.20 percentage of change
Standard Error 5.100
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Percentage of Change in Smoking Withdrawal Symptoms
Gastrointestinal - % change 6 months from Quit Day
|
-33.66 percentage of change
Standard Error 18.204
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Percentage of Change in Smoking Withdrawal Symptoms
Respiratory -- % change 1 week from Quit Day
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7.26 percentage of change
Standard Error 6.978
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Percentage of Change in Smoking Withdrawal Symptoms
Respiratory -- % change 3 weeks from Quit Day
|
2.06 percentage of change
Standard Error 11.161
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Percentage of Change in Smoking Withdrawal Symptoms
Respiratory -- % change 6 weeks from Quit Day
|
-5.16 percentage of change
Standard Error 8.628
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Percentage of Change in Smoking Withdrawal Symptoms
Respiratory -- % change 10 weeks from Quit Day
|
-13.28 percentage of change
Standard Error 8.696
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Percentage of Change in Smoking Withdrawal Symptoms
Habit -- % change 3 weeks from Quit Day
|
-11.41 percentage of change
Standard Error 6.309
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Percentage of Change in Smoking Withdrawal Symptoms
Habit -- % change 6 weeks from Quit Day
|
-12.22 percentage of change
Standard Error 7.705
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Percentage of Change in Smoking Withdrawal Symptoms
Habit -- % change 10 weeks from Quit Day
|
1.49 percentage of change
Standard Error 14.642
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Percentage of Change in Smoking Withdrawal Symptoms
Habit -- % change 6 months from Quit Day
|
-38.79 percentage of change
Standard Error 19.553
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SECONDARY outcome
Timeframe: Baseline and 1 weekPopulation: Participants who received Moclobemide.
The initial response to nicotine patch will be assessed by looking at the percent change in expired air carbon monoxide (CO) at the end of week one (Study Visit 2) relative to baseline (Study Visit 1).
Outcome measures
| Measure |
Nicotine Patch+Moclobemide
n=37 Participants
After 1 week of pre-cessation nicotine patch treatment (21 mg/24 h patches), participants will receive moclobemide (400 mg/day in 2 divided doses) for 11 weeks, ending 10 weeks after the target quit date. Nicotine patch treatment will continue at 21 mg/24 h for an additional week prior to the quit date, and then for 6 weeks after the quit date, followed by 14 mg/24 h for 2 weeks and 7 mg/24 h for 2 weeks. All treatment will terminate 10 weeks after the quit date.
Nicotine Patch: Pre-Quit Period: 2 weeks of patch use (21mg/24hr)
Post Quit Period: 10 weeks of patch use (21mg/24hr for 6 weeks, 14mg/24hr for 2 weeks, and 7mg/24hr for 2 weeks)
Moclobemide: Pre-Quit Period: 1 week of moclobemide use (400 mg/day in 2 divided doses)
Post Quit Period: 10 weeks of moclobemide use (400 mg/day in 2 divided doses)
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|---|---|
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Percentage of Change in Expired Air Carbon Monoxide (CO) During the First Week of Nicotine Patch Treatment.
|
-18.38 percentage of change
Standard Error 5.551
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OTHER_PRE_SPECIFIED outcome
Timeframe: 1, 2, 4, 7 and 11 weeks after starting Moclobemide + Nicotine PatchPopulation: Participants who received Moclobemide.
Safety of the moclobemide + nicotine patch treatment will be assessed by tabulating the number of participants rating side effects \> "moderate".
Outcome measures
| Measure |
Nicotine Patch+Moclobemide
n=37 Participants
After 1 week of pre-cessation nicotine patch treatment (21 mg/24 h patches), participants will receive moclobemide (400 mg/day in 2 divided doses) for 11 weeks, ending 10 weeks after the target quit date. Nicotine patch treatment will continue at 21 mg/24 h for an additional week prior to the quit date, and then for 6 weeks after the quit date, followed by 14 mg/24 h for 2 weeks and 7 mg/24 h for 2 weeks. All treatment will terminate 10 weeks after the quit date.
Nicotine Patch: Pre-Quit Period: 2 weeks of patch use (21mg/24hr)
Post Quit Period: 10 weeks of patch use (21mg/24hr for 6 weeks, 14mg/24hr for 2 weeks, and 7mg/24hr for 2 weeks)
Moclobemide: Pre-Quit Period: 1 week of moclobemide use (400 mg/day in 2 divided doses)
Post Quit Period: 10 weeks of moclobemide use (400 mg/day in 2 divided doses)
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|---|---|
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Safety of Moclobemide + Nicotine Patch
|
21 participants
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OTHER_PRE_SPECIFIED outcome
Timeframe: 1, 2, 4, 7 and 11 weeks after starting Moclobemide + Nicotine PatchPopulation: Participants who received Moclobemide.
Tolerability of the moclobemide + nicotine patch treatment will be assessed by tabulating the number of participants requiring dose reductions (or discontinuation of medication).
Outcome measures
| Measure |
Nicotine Patch+Moclobemide
n=37 Participants
After 1 week of pre-cessation nicotine patch treatment (21 mg/24 h patches), participants will receive moclobemide (400 mg/day in 2 divided doses) for 11 weeks, ending 10 weeks after the target quit date. Nicotine patch treatment will continue at 21 mg/24 h for an additional week prior to the quit date, and then for 6 weeks after the quit date, followed by 14 mg/24 h for 2 weeks and 7 mg/24 h for 2 weeks. All treatment will terminate 10 weeks after the quit date.
Nicotine Patch: Pre-Quit Period: 2 weeks of patch use (21mg/24hr)
Post Quit Period: 10 weeks of patch use (21mg/24hr for 6 weeks, 14mg/24hr for 2 weeks, and 7mg/24hr for 2 weeks)
Moclobemide: Pre-Quit Period: 1 week of moclobemide use (400 mg/day in 2 divided doses)
Post Quit Period: 10 weeks of moclobemide use (400 mg/day in 2 divided doses)
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|---|---|
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Tolerability of Moclobemide + Nicotine Patch
|
17 participants
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Adverse Events
Nicotine Patch+Moclobemide
Serious events: 0 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Nicotine Patch+Moclobemide
n=37 participants at risk
After 1 week of pre-cessation nicotine patch treatment (21 mg/24 h patches), participants will receive moclobemide (400 mg/day in 2 divided doses) for 11 weeks, ending 10 weeks after the target quit date. Nicotine patch treatment will continue at 21 mg/24 h for an additional week prior to the quit date, and then for 6 weeks after the quit date, followed by 14 mg/24 h for 2 weeks and 7 mg/24 h for 2 weeks. All treatment will terminate 10 weeks after the quit date.
Nicotine Patch: Pre-Quit Period: 2 weeks of patch use (21mg/24hr)
Post Quit Period: 10 weeks of patch use (21mg/24hr for 6 weeks, 14mg/24hr for 2 weeks, and 7mg/24hr for 2 weeks)
Moclobemide: Pre-Quit Period: 1 week of moclobemide use (400 mg/day in 2 divided doses)
Post Quit Period: 10 weeks of moclobemide use (400 mg/day in 2 divided doses)
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|---|---|
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Nervous system disorders
Insomnia
|
32.4%
12/37 • Number of events 21 • Subjects were receiving study drugs for twelve weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
One subject discontinued study participation after the first study session; therefore, no side effects data pertaining to study interventions were collected for this subject.
|
|
Nervous system disorders
Tiredness
|
32.4%
12/37 • Number of events 14 • Subjects were receiving study drugs for twelve weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
One subject discontinued study participation after the first study session; therefore, no side effects data pertaining to study interventions were collected for this subject.
|
|
Nervous system disorders
Nightmares
|
13.5%
5/37 • Number of events 5 • Subjects were receiving study drugs for twelve weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
One subject discontinued study participation after the first study session; therefore, no side effects data pertaining to study interventions were collected for this subject.
|
|
Nervous system disorders
Vivid dreams
|
35.1%
13/37 • Number of events 27 • Subjects were receiving study drugs for twelve weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
One subject discontinued study participation after the first study session; therefore, no side effects data pertaining to study interventions were collected for this subject.
|
|
Nervous system disorders
Dizziness
|
5.4%
2/37 • Number of events 2 • Subjects were receiving study drugs for twelve weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
One subject discontinued study participation after the first study session; therefore, no side effects data pertaining to study interventions were collected for this subject.
|
|
Nervous system disorders
Headache
|
18.9%
7/37 • Number of events 11 • Subjects were receiving study drugs for twelve weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
One subject discontinued study participation after the first study session; therefore, no side effects data pertaining to study interventions were collected for this subject.
|
|
Nervous system disorders
Excessive sweating
|
10.8%
4/37 • Number of events 14 • Subjects were receiving study drugs for twelve weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
One subject discontinued study participation after the first study session; therefore, no side effects data pertaining to study interventions were collected for this subject.
|
|
General disorders
Increased appetite
|
18.9%
7/37 • Number of events 11 • Subjects were receiving study drugs for twelve weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
One subject discontinued study participation after the first study session; therefore, no side effects data pertaining to study interventions were collected for this subject.
|
|
General disorders
Loss of appetite
|
5.4%
2/37 • Number of events 2 • Subjects were receiving study drugs for twelve weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
One subject discontinued study participation after the first study session; therefore, no side effects data pertaining to study interventions were collected for this subject.
|
|
Nervous system disorders
Altered taste
|
16.2%
6/37 • Number of events 8 • Subjects were receiving study drugs for twelve weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
One subject discontinued study participation after the first study session; therefore, no side effects data pertaining to study interventions were collected for this subject.
|
|
General disorders
Dry mouth
|
24.3%
9/37 • Number of events 18 • Subjects were receiving study drugs for twelve weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
One subject discontinued study participation after the first study session; therefore, no side effects data pertaining to study interventions were collected for this subject.
|
|
General disorders
Thirst
|
27.0%
10/37 • Number of events 19 • Subjects were receiving study drugs for twelve weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
One subject discontinued study participation after the first study session; therefore, no side effects data pertaining to study interventions were collected for this subject.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.8%
4/37 • Number of events 6 • Subjects were receiving study drugs for twelve weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
One subject discontinued study participation after the first study session; therefore, no side effects data pertaining to study interventions were collected for this subject.
|
|
General disorders
Chest Pain
|
5.4%
2/37 • Number of events 2 • Subjects were receiving study drugs for twelve weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
One subject discontinued study participation after the first study session; therefore, no side effects data pertaining to study interventions were collected for this subject.
|
|
Gastrointestinal disorders
Nausea
|
10.8%
4/37 • Number of events 4 • Subjects were receiving study drugs for twelve weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
One subject discontinued study participation after the first study session; therefore, no side effects data pertaining to study interventions were collected for this subject.
|
|
Gastrointestinal disorders
Diarrhea
|
5.4%
2/37 • Number of events 2 • Subjects were receiving study drugs for twelve weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
One subject discontinued study participation after the first study session; therefore, no side effects data pertaining to study interventions were collected for this subject.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.4%
2/37 • Number of events 2 • Subjects were receiving study drugs for twelve weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
One subject discontinued study participation after the first study session; therefore, no side effects data pertaining to study interventions were collected for this subject.
|
|
Gastrointestinal disorders
Heartburn
|
8.1%
3/37 • Number of events 4 • Subjects were receiving study drugs for twelve weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
One subject discontinued study participation after the first study session; therefore, no side effects data pertaining to study interventions were collected for this subject.
|
|
Musculoskeletal and connective tissue disorders
Muscle / joint pain
|
13.5%
5/37 • Number of events 7 • Subjects were receiving study drugs for twelve weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
One subject discontinued study participation after the first study session; therefore, no side effects data pertaining to study interventions were collected for this subject.
|
|
Psychiatric disorders
Anxiety
|
13.5%
5/37 • Number of events 6 • Subjects were receiving study drugs for twelve weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
One subject discontinued study participation after the first study session; therefore, no side effects data pertaining to study interventions were collected for this subject.
|
|
Psychiatric disorders
Depression
|
5.4%
2/37 • Number of events 5 • Subjects were receiving study drugs for twelve weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
One subject discontinued study participation after the first study session; therefore, no side effects data pertaining to study interventions were collected for this subject.
|
|
Nervous system disorders
Agitation / restlessness
|
10.8%
4/37 • Number of events 7 • Subjects were receiving study drugs for twelve weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
One subject discontinued study participation after the first study session; therefore, no side effects data pertaining to study interventions were collected for this subject.
|
|
Skin and subcutaneous tissue disorders
Itching at patch site
|
29.7%
11/37 • Number of events 14 • Subjects were receiving study drugs for twelve weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
One subject discontinued study participation after the first study session; therefore, no side effects data pertaining to study interventions were collected for this subject.
|
|
Skin and subcutaneous tissue disorders
Rash at patch site
|
8.1%
3/37 • Number of events 3 • Subjects were receiving study drugs for twelve weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
One subject discontinued study participation after the first study session; therefore, no side effects data pertaining to study interventions were collected for this subject.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place