Trial Outcomes & Findings for Sativex and Behavioral-relapse Prevention Strategy in Cannabis Dependence (NCT NCT01747850)
NCT ID: NCT01747850
Last Updated: 2017-10-02
Results Overview
Assessment of tolerability will be determined by the number of subjects that withdrawal from the study due to SAEs.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
45 participants
Primary outcome timeframe
six months
Results posted on
2017-10-02
Participant Flow
Participant milestones
| Measure |
Pilot Study
The first five subjects will be treatment-seekers that will be treated open-label. These first subjects will allow us to determine if our schedule for dosing is appropriate for the subsequent phase of the study.
Motivational Enhancement/Cognitive Behavioral Therapy: All participants will receive a combination of pharmacotherapy (Sativex) associated with a weekly intervention of combined Motivational Enhancement Therapy and Cognitive Behavioral Therapy.
Sativex: Study subjects will gradually increase the maximal allowed dose of Sativex starting at five sprays per day for the first two days and increasing of five sprays per day until reaching the max number of 42 sprays maximal per day at end of week 2 (Day 11). The medication treatment phase will then be continued for an additional 9 weeks (the last week will be a reduction phase with the use of Spray that will be decreased by 50% to avoid abrupt withdrawal).
|
Sativex
Intervention consist on Sativex Spray (Δ9-tetrahydrocannabinol/cannabidiol). Study subjects will be randomized in blocks of ten to one of the two groups (Sativex vs. placebo) in a double blind manner. There will be a gradual increase of the maximal allowed dose starting at five sprays per day for the first two days and increasing of five sprays per day until reaching the max number of 42 sprays per day at the end of week 2. There will be a total of 12 weeks of drug exposure (the last week will be a reduction phase with the use of Spray that will be decreased by 50% to avoid abrupt withdrawal). All participants will receive a combination of pharmacotherapy (Sativex or Placebo) associated with a weekly intervention of combined Motivational Enhancement/Cognitive Behavioral Therapy.
|
Placebo Spray
Participants will receive a combination of Placebo spray associated with a weekly intervention of combined Motivational Enhancement Therapy and Cognitive Behavioral Therapy
Placebo spray: Study subjects will gradually increase the maximal allowed dose of Placebo starting at five sprays per day for the first two days and increasing of five sprays per day until reaching the max number of 42 sprays maximal per day at end of week 2 (Day 11). The Placebo treatment phase will then be continued for an additional 9 weeks (the last week will be a reduction phase with the use of Placebo Spray that will be decreased by 50%). Then exposure to Placebo will be stopped (so there will be a total of 12 weeks Placebo treatment exposure).
|
|---|---|---|---|
|
Overall Study
STARTED
|
5
|
20
|
20
|
|
Overall Study
COMPLETED
|
4
|
13
|
14
|
|
Overall Study
NOT COMPLETED
|
1
|
7
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sativex and Behavioral-relapse Prevention Strategy in Cannabis Dependence
Baseline characteristics by cohort
| Measure |
Sativex
n=20 Participants
Intervention consist on Sativex Spray (Δ9-tetrahydrocannabinol/cannabidiol). There will be a gradual increase of the maximal allowed dose starting at five sprays per day for the first two days and increasing of five sprays per day until reaching the max number of 42 sprays per day at the end of week 2. There will be a total of 12 weeks of drug exposure associated with a weekly intervention of combined Motivational Enhancement/Cognitive Behavioral Therapy.
Sativex: Study subjects will gradually increase the maximal allowed dose of Sativex starting at five sprays per day for the first two days and increasing of five sprays per day until reaching the max number of 42 sprays maximal per day at end of week 2 (Day 11). The medication treatment phase will then be continued for an additional 9 weeks (the last week will be a reduction phase with the use of Spray that will be decreased by 50% to avoid abrupt withdrawal).
|
Placebo Spray
n=20 Participants
Participants will receive a combination of Placebo spray associated with a weekly intervention of combined Motivational Enhancement Therapy and Cognitive Behavioral Therapy
Placebo spray: Study subjects will gradually increase the maximal allowed dose of Placebo starting at five sprays per day for the first two days and increasing of five sprays per day until reaching the max number of 42 sprays maximal per day at end of week 2 (Day 11). The Placebo treatment phase will then be continued for an additional 9 weeks (the last week will be a reduction phase with the use of Placebo Spray that will be decreased by 50%).
|
Pilot Study
n=5 Participants
The first five subjects will be treatment-seekers that fit our inclusion/exclusion criteria and that will be treated open-label. These first subjects will allow us to determine if our schedule for dosing is appropriate for the subsequent phase of the study.
All participants will receive a combination of pharmacotherapy (Sativex) associated with a weekly intervention of combined Motivational Enhancement Therapy and Cognitive Behavioral Therapy.
Sativex: Study subjects will gradually increase the maximal allowed dose of Sativex starting at five sprays per day for the first two days and increasing of five sprays per day until reaching the max number of 42 sprays maximal per day at end of week 2 (Day 11). The medication treatment phase will then be continued for an additional 9 weeks (the last week will be a reduction phase with the use of Spray that will be decreased by 50% to avoid abrupt withdrawal).
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
|
Region of Enrollment
Canada
|
20 participants
n=5 Participants
|
20 participants
n=7 Participants
|
5 participants
n=5 Participants
|
45 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: six monthsAssessment of tolerability will be determined by the number of subjects that withdrawal from the study due to SAEs.
Outcome measures
| Measure |
Sativex # of Participants That Withdrew Due SAE
n=20 Participants
Intervention consist on Sativex Spray (Δ9-tetrahydrocannabinol/cannabidiol). There will be a total of 12 weeks of drug exposure. All participants will receive a combination of pharmacotherapy (Sativex associated with a weekly intervention of combined Motivational Enhancement/Cognitive Behavioral Therapy.
|
Placebo # of Participants That Withdrew Due SAE
n=20 Participants
Participants will receive a combination of Placebo spray associated with a weekly intervention of combined Motivational Enhancement Therapy and Cognitive Behavioral Therapy
|
Pilot Study # of Participants That Withdrew Due SAE
n=5 Participants
The first five subjects will be treatment-seekers that fit our inclusion/exclusion criteria and that will be treated open-label. These subjects will be instructed to use the Sativex Spray according to the induction schedule provided above. These first subjects will allow us to determine if our schedule for dosing is appropriate for the subsequent phase of the study.
Motivational Enhancement/Cognitive Behavioral Therapy: All participants will receive a combination of pharmacotherapy (Sativex or Placebo) associated with a weekly intervention of combined Motivational Enhancement Therapy and Cognitive Behavioral Therapy.
Sativex: Study subjects will gradually increase the maximal allowed dose of Sativex starting at five sprays per day for the first two days and increasing of five sprays per day until reaching the max number of 42 sprays maximal per day at end of week 2 (Day 11). The target quit date will be set at Day 21 (but subjects will be allowed to stop using cannabis before if
|
|---|---|---|---|
|
Tolerability
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: six monthsThe percentage of days that participants self-reported use of cannabis over the study duration until 6 month follow-up will be assessed (i.e. smoking diary self-report)
Outcome measures
| Measure |
Sativex # of Participants That Withdrew Due SAE
n=20 Participants
Intervention consist on Sativex Spray (Δ9-tetrahydrocannabinol/cannabidiol). There will be a total of 12 weeks of drug exposure. All participants will receive a combination of pharmacotherapy (Sativex associated with a weekly intervention of combined Motivational Enhancement/Cognitive Behavioral Therapy.
|
Placebo # of Participants That Withdrew Due SAE
n=20 Participants
Participants will receive a combination of Placebo spray associated with a weekly intervention of combined Motivational Enhancement Therapy and Cognitive Behavioral Therapy
|
Pilot Study # of Participants That Withdrew Due SAE
n=5 Participants
The first five subjects will be treatment-seekers that fit our inclusion/exclusion criteria and that will be treated open-label. These subjects will be instructed to use the Sativex Spray according to the induction schedule provided above. These first subjects will allow us to determine if our schedule for dosing is appropriate for the subsequent phase of the study.
Motivational Enhancement/Cognitive Behavioral Therapy: All participants will receive a combination of pharmacotherapy (Sativex or Placebo) associated with a weekly intervention of combined Motivational Enhancement Therapy and Cognitive Behavioral Therapy.
Sativex: Study subjects will gradually increase the maximal allowed dose of Sativex starting at five sprays per day for the first two days and increasing of five sprays per day until reaching the max number of 42 sprays maximal per day at end of week 2 (Day 11). The target quit date will be set at Day 21 (but subjects will be allowed to stop using cannabis before if
|
|---|---|---|---|
|
Cannabis Use (in Days)
|
42.9 percentage of days
Standard Deviation 7.7
|
47.1 percentage of days
Standard Deviation 12.9
|
48.3 percentage of days
Standard Deviation 22.5
|
SECONDARY outcome
Timeframe: six monthsEffect of Sativex on withdrawal symptom scores will be assessed using the Marijuana Withdrawal Checklist (MWC). Average Total score for the trial (6 months) is reported. Range 0 - 46. Higher scores indicate more severe symptoms associated with marijuana withdrawal.
Outcome measures
| Measure |
Sativex # of Participants That Withdrew Due SAE
n=20 Participants
Intervention consist on Sativex Spray (Δ9-tetrahydrocannabinol/cannabidiol). There will be a total of 12 weeks of drug exposure. All participants will receive a combination of pharmacotherapy (Sativex associated with a weekly intervention of combined Motivational Enhancement/Cognitive Behavioral Therapy.
|
Placebo # of Participants That Withdrew Due SAE
n=20 Participants
Participants will receive a combination of Placebo spray associated with a weekly intervention of combined Motivational Enhancement Therapy and Cognitive Behavioral Therapy
|
Pilot Study # of Participants That Withdrew Due SAE
n=5 Participants
The first five subjects will be treatment-seekers that fit our inclusion/exclusion criteria and that will be treated open-label. These subjects will be instructed to use the Sativex Spray according to the induction schedule provided above. These first subjects will allow us to determine if our schedule for dosing is appropriate for the subsequent phase of the study.
Motivational Enhancement/Cognitive Behavioral Therapy: All participants will receive a combination of pharmacotherapy (Sativex or Placebo) associated with a weekly intervention of combined Motivational Enhancement Therapy and Cognitive Behavioral Therapy.
Sativex: Study subjects will gradually increase the maximal allowed dose of Sativex starting at five sprays per day for the first two days and increasing of five sprays per day until reaching the max number of 42 sprays maximal per day at end of week 2 (Day 11). The target quit date will be set at Day 21 (but subjects will be allowed to stop using cannabis before if
|
|---|---|---|---|
|
Withdrawal
|
5.0 Total Withdrawal score
Standard Deviation 4.7
|
5.1 Total Withdrawal score
Standard Deviation 3.9
|
2.7 Total Withdrawal score
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: six monthsEffect of Sativex on cannabis craving will be assessed using the Marijuana Craving Questionnaire (MCQ). Average Total score for the trial (6 months) is reported. Participants rate the 12 items using a 7-item Likert scale ranging from strongly disagree to strongly agree, and the total score ranges from 4 to 28 (subscales compulsivity (mean items 2, 7 and 10), emotionality (mean items 4, 6 and 9), expectancy (mean items 5, 11 and 12) and purposefulness (mean items 1, 3 and 8); total score is the sum for the 4 subscales). Higher scores indicate more severe craving for marijuana.
Outcome measures
| Measure |
Sativex # of Participants That Withdrew Due SAE
n=20 Participants
Intervention consist on Sativex Spray (Δ9-tetrahydrocannabinol/cannabidiol). There will be a total of 12 weeks of drug exposure. All participants will receive a combination of pharmacotherapy (Sativex associated with a weekly intervention of combined Motivational Enhancement/Cognitive Behavioral Therapy.
|
Placebo # of Participants That Withdrew Due SAE
n=20 Participants
Participants will receive a combination of Placebo spray associated with a weekly intervention of combined Motivational Enhancement Therapy and Cognitive Behavioral Therapy
|
Pilot Study # of Participants That Withdrew Due SAE
n=5 Participants
The first five subjects will be treatment-seekers that fit our inclusion/exclusion criteria and that will be treated open-label. These subjects will be instructed to use the Sativex Spray according to the induction schedule provided above. These first subjects will allow us to determine if our schedule for dosing is appropriate for the subsequent phase of the study.
Motivational Enhancement/Cognitive Behavioral Therapy: All participants will receive a combination of pharmacotherapy (Sativex or Placebo) associated with a weekly intervention of combined Motivational Enhancement Therapy and Cognitive Behavioral Therapy.
Sativex: Study subjects will gradually increase the maximal allowed dose of Sativex starting at five sprays per day for the first two days and increasing of five sprays per day until reaching the max number of 42 sprays maximal per day at end of week 2 (Day 11). The target quit date will be set at Day 21 (but subjects will be allowed to stop using cannabis before if
|
|---|---|---|---|
|
Cannabis Craving
|
8.2 Total Craving Scores
Standard Deviation 4.3
|
9.6 Total Craving Scores
Standard Deviation 5.7
|
9.5 Total Craving Scores
Standard Deviation 5.2
|
SECONDARY outcome
Timeframe: six monthsAmount of cannabis used in grams over the study duration until 6 month follow-up will be assessed
Outcome measures
| Measure |
Sativex # of Participants That Withdrew Due SAE
n=20 Participants
Intervention consist on Sativex Spray (Δ9-tetrahydrocannabinol/cannabidiol). There will be a total of 12 weeks of drug exposure. All participants will receive a combination of pharmacotherapy (Sativex associated with a weekly intervention of combined Motivational Enhancement/Cognitive Behavioral Therapy.
|
Placebo # of Participants That Withdrew Due SAE
n=20 Participants
Participants will receive a combination of Placebo spray associated with a weekly intervention of combined Motivational Enhancement Therapy and Cognitive Behavioral Therapy
|
Pilot Study # of Participants That Withdrew Due SAE
n=5 Participants
The first five subjects will be treatment-seekers that fit our inclusion/exclusion criteria and that will be treated open-label. These subjects will be instructed to use the Sativex Spray according to the induction schedule provided above. These first subjects will allow us to determine if our schedule for dosing is appropriate for the subsequent phase of the study.
Motivational Enhancement/Cognitive Behavioral Therapy: All participants will receive a combination of pharmacotherapy (Sativex or Placebo) associated with a weekly intervention of combined Motivational Enhancement Therapy and Cognitive Behavioral Therapy.
Sativex: Study subjects will gradually increase the maximal allowed dose of Sativex starting at five sprays per day for the first two days and increasing of five sprays per day until reaching the max number of 42 sprays maximal per day at end of week 2 (Day 11). The target quit date will be set at Day 21 (but subjects will be allowed to stop using cannabis before if
|
|---|---|---|---|
|
Cannabis Use (Grams)
|
2.3 grams of cannabis
Standard Error 0.76
|
3.5 grams of cannabis
Standard Error 1.26
|
1.6 grams of cannabis
Standard Error 1.48
|
Adverse Events
Sativex
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Placebo Spray
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Pilot Study
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sativex
n=20 participants at risk
Intervention consist on Sativex Spray (Δ9-tetrahydrocannabinol/cannabidiol). There will be a gradual increase of the maximal allowed dose starting at five sprays per day for the first two days and increasing of five sprays per day until reaching the max number of 42 sprays per day at the end of week 2. There will be a total of 12 weeks of drug exposure.
All participants will receive a combination of pharmacotherapy (Sativex ) associated with a weekly intervention of combined Motivational Enhancement Therapy and Cognitive Behavioral Therapy.
|
Placebo Spray
n=20 participants at risk
Placebo spray: Study subjects will gradually increase the maximal allowed dose of Placebo starting at five sprays per day for the first two days and increasing of five sprays per day until reaching the max number of 42 sprays maximal per day at end of week 2 (Day 11). There will be a total of 12 weeks Placebo treatment exposure.
Participants will receive a combination of Placebo spray associated with a weekly intervention of combined Motivational Enhancement Therapy and Cognitive Behavioral Therapy
|
Pilot Study
n=5 participants at risk
The first five subjects will be treatment-seekers that will be treated open-label.
Study subjects will gradually increase the maximal allowed dose of Sativex starting at five sprays per day for the first two days and increasing of five sprays per day until reaching the max number of 42 sprays maximal per day at end of week 2 (Day 11). There will be a total of 12 weeks medication treatment exposure).
Motivational Enhancement/Cognitive Behavioral Therapy: All participants will receive a combination of pharmacotherapy (Sativex) associated with a weekly intervention of combined Motivational Enhancement Therapy and Cognitive Behavioral Therapy.
|
|---|---|---|---|
|
Gastrointestinal disorders
Indigestion
|
0.00%
0/20 • 1 year, 10 months
ADVERSE EVENT COLLECTION BY QUESTIONNAIRE DURING STUDY VISITS (SAFTEE)
|
0.00%
0/20 • 1 year, 10 months
ADVERSE EVENT COLLECTION BY QUESTIONNAIRE DURING STUDY VISITS (SAFTEE)
|
20.0%
1/5 • 1 year, 10 months
ADVERSE EVENT COLLECTION BY QUESTIONNAIRE DURING STUDY VISITS (SAFTEE)
|
|
Nervous system disorders
Insomnia
|
55.0%
11/20 • 1 year, 10 months
ADVERSE EVENT COLLECTION BY QUESTIONNAIRE DURING STUDY VISITS (SAFTEE)
|
40.0%
8/20 • 1 year, 10 months
ADVERSE EVENT COLLECTION BY QUESTIONNAIRE DURING STUDY VISITS (SAFTEE)
|
60.0%
3/5 • 1 year, 10 months
ADVERSE EVENT COLLECTION BY QUESTIONNAIRE DURING STUDY VISITS (SAFTEE)
|
|
Vascular disorders
Headache
|
20.0%
4/20 • 1 year, 10 months
ADVERSE EVENT COLLECTION BY QUESTIONNAIRE DURING STUDY VISITS (SAFTEE)
|
50.0%
10/20 • 1 year, 10 months
ADVERSE EVENT COLLECTION BY QUESTIONNAIRE DURING STUDY VISITS (SAFTEE)
|
60.0%
3/5 • 1 year, 10 months
ADVERSE EVENT COLLECTION BY QUESTIONNAIRE DURING STUDY VISITS (SAFTEE)
|
|
Gastrointestinal disorders
Oro Mucal
|
10.0%
2/20 • 1 year, 10 months
ADVERSE EVENT COLLECTION BY QUESTIONNAIRE DURING STUDY VISITS (SAFTEE)
|
10.0%
2/20 • 1 year, 10 months
ADVERSE EVENT COLLECTION BY QUESTIONNAIRE DURING STUDY VISITS (SAFTEE)
|
40.0%
2/5 • 1 year, 10 months
ADVERSE EVENT COLLECTION BY QUESTIONNAIRE DURING STUDY VISITS (SAFTEE)
|
|
Respiratory, thoracic and mediastinal disorders
Cold/Influenza
|
20.0%
4/20 • 1 year, 10 months
ADVERSE EVENT COLLECTION BY QUESTIONNAIRE DURING STUDY VISITS (SAFTEE)
|
30.0%
6/20 • 1 year, 10 months
ADVERSE EVENT COLLECTION BY QUESTIONNAIRE DURING STUDY VISITS (SAFTEE)
|
60.0%
3/5 • 1 year, 10 months
ADVERSE EVENT COLLECTION BY QUESTIONNAIRE DURING STUDY VISITS (SAFTEE)
|
|
Cardiac disorders
Cardiovascular
|
0.00%
0/20 • 1 year, 10 months
ADVERSE EVENT COLLECTION BY QUESTIONNAIRE DURING STUDY VISITS (SAFTEE)
|
10.0%
2/20 • 1 year, 10 months
ADVERSE EVENT COLLECTION BY QUESTIONNAIRE DURING STUDY VISITS (SAFTEE)
|
0.00%
0/5 • 1 year, 10 months
ADVERSE EVENT COLLECTION BY QUESTIONNAIRE DURING STUDY VISITS (SAFTEE)
|
|
General disorders
Nightmare
|
0.00%
0/20 • 1 year, 10 months
ADVERSE EVENT COLLECTION BY QUESTIONNAIRE DURING STUDY VISITS (SAFTEE)
|
10.0%
2/20 • 1 year, 10 months
ADVERSE EVENT COLLECTION BY QUESTIONNAIRE DURING STUDY VISITS (SAFTEE)
|
20.0%
1/5 • 1 year, 10 months
ADVERSE EVENT COLLECTION BY QUESTIONNAIRE DURING STUDY VISITS (SAFTEE)
|
|
Gastrointestinal disorders
Diarrhea
|
10.0%
2/20 • 1 year, 10 months
ADVERSE EVENT COLLECTION BY QUESTIONNAIRE DURING STUDY VISITS (SAFTEE)
|
20.0%
4/20 • 1 year, 10 months
ADVERSE EVENT COLLECTION BY QUESTIONNAIRE DURING STUDY VISITS (SAFTEE)
|
20.0%
1/5 • 1 year, 10 months
ADVERSE EVENT COLLECTION BY QUESTIONNAIRE DURING STUDY VISITS (SAFTEE)
|
|
Musculoskeletal and connective tissue disorders
Pain
|
0.00%
0/20 • 1 year, 10 months
ADVERSE EVENT COLLECTION BY QUESTIONNAIRE DURING STUDY VISITS (SAFTEE)
|
10.0%
2/20 • 1 year, 10 months
ADVERSE EVENT COLLECTION BY QUESTIONNAIRE DURING STUDY VISITS (SAFTEE)
|
40.0%
2/5 • 1 year, 10 months
ADVERSE EVENT COLLECTION BY QUESTIONNAIRE DURING STUDY VISITS (SAFTEE)
|
|
Psychiatric disorders
Mood Disturbance
|
10.0%
2/20 • 1 year, 10 months
ADVERSE EVENT COLLECTION BY QUESTIONNAIRE DURING STUDY VISITS (SAFTEE)
|
0.00%
0/20 • 1 year, 10 months
ADVERSE EVENT COLLECTION BY QUESTIONNAIRE DURING STUDY VISITS (SAFTEE)
|
20.0%
1/5 • 1 year, 10 months
ADVERSE EVENT COLLECTION BY QUESTIONNAIRE DURING STUDY VISITS (SAFTEE)
|
|
Psychiatric disorders
Decrease in Libido
|
0.00%
0/20 • 1 year, 10 months
ADVERSE EVENT COLLECTION BY QUESTIONNAIRE DURING STUDY VISITS (SAFTEE)
|
15.0%
3/20 • 1 year, 10 months
ADVERSE EVENT COLLECTION BY QUESTIONNAIRE DURING STUDY VISITS (SAFTEE)
|
0.00%
0/5 • 1 year, 10 months
ADVERSE EVENT COLLECTION BY QUESTIONNAIRE DURING STUDY VISITS (SAFTEE)
|
|
General disorders
Decreased appetite
|
10.0%
2/20 • 1 year, 10 months
ADVERSE EVENT COLLECTION BY QUESTIONNAIRE DURING STUDY VISITS (SAFTEE)
|
10.0%
2/20 • 1 year, 10 months
ADVERSE EVENT COLLECTION BY QUESTIONNAIRE DURING STUDY VISITS (SAFTEE)
|
20.0%
1/5 • 1 year, 10 months
ADVERSE EVENT COLLECTION BY QUESTIONNAIRE DURING STUDY VISITS (SAFTEE)
|
|
Gastrointestinal disorders
Nausea
|
10.0%
2/20 • 1 year, 10 months
ADVERSE EVENT COLLECTION BY QUESTIONNAIRE DURING STUDY VISITS (SAFTEE)
|
30.0%
6/20 • 1 year, 10 months
ADVERSE EVENT COLLECTION BY QUESTIONNAIRE DURING STUDY VISITS (SAFTEE)
|
40.0%
2/5 • 1 year, 10 months
ADVERSE EVENT COLLECTION BY QUESTIONNAIRE DURING STUDY VISITS (SAFTEE)
|
|
Renal and urinary disorders
Urinary Problems
|
10.0%
2/20 • 1 year, 10 months
ADVERSE EVENT COLLECTION BY QUESTIONNAIRE DURING STUDY VISITS (SAFTEE)
|
0.00%
0/20 • 1 year, 10 months
ADVERSE EVENT COLLECTION BY QUESTIONNAIRE DURING STUDY VISITS (SAFTEE)
|
0.00%
0/5 • 1 year, 10 months
ADVERSE EVENT COLLECTION BY QUESTIONNAIRE DURING STUDY VISITS (SAFTEE)
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/20 • 1 year, 10 months
ADVERSE EVENT COLLECTION BY QUESTIONNAIRE DURING STUDY VISITS (SAFTEE)
|
10.0%
2/20 • 1 year, 10 months
ADVERSE EVENT COLLECTION BY QUESTIONNAIRE DURING STUDY VISITS (SAFTEE)
|
20.0%
1/5 • 1 year, 10 months
ADVERSE EVENT COLLECTION BY QUESTIONNAIRE DURING STUDY VISITS (SAFTEE)
|
|
Skin and subcutaneous tissue disorders
Skin rashes
|
0.00%
0/20 • 1 year, 10 months
ADVERSE EVENT COLLECTION BY QUESTIONNAIRE DURING STUDY VISITS (SAFTEE)
|
0.00%
0/20 • 1 year, 10 months
ADVERSE EVENT COLLECTION BY QUESTIONNAIRE DURING STUDY VISITS (SAFTEE)
|
20.0%
1/5 • 1 year, 10 months
ADVERSE EVENT COLLECTION BY QUESTIONNAIRE DURING STUDY VISITS (SAFTEE)
|
|
Cardiac disorders
Light Headedness
|
0.00%
0/20 • 1 year, 10 months
ADVERSE EVENT COLLECTION BY QUESTIONNAIRE DURING STUDY VISITS (SAFTEE)
|
0.00%
0/20 • 1 year, 10 months
ADVERSE EVENT COLLECTION BY QUESTIONNAIRE DURING STUDY VISITS (SAFTEE)
|
20.0%
1/5 • 1 year, 10 months
ADVERSE EVENT COLLECTION BY QUESTIONNAIRE DURING STUDY VISITS (SAFTEE)
|
|
Nervous system disorders
excessive sweating
|
0.00%
0/20 • 1 year, 10 months
ADVERSE EVENT COLLECTION BY QUESTIONNAIRE DURING STUDY VISITS (SAFTEE)
|
10.0%
2/20 • 1 year, 10 months
ADVERSE EVENT COLLECTION BY QUESTIONNAIRE DURING STUDY VISITS (SAFTEE)
|
20.0%
1/5 • 1 year, 10 months
ADVERSE EVENT COLLECTION BY QUESTIONNAIRE DURING STUDY VISITS (SAFTEE)
|
|
General disorders
Ringing in ears
|
10.0%
2/20 • 1 year, 10 months
ADVERSE EVENT COLLECTION BY QUESTIONNAIRE DURING STUDY VISITS (SAFTEE)
|
0.00%
0/20 • 1 year, 10 months
ADVERSE EVENT COLLECTION BY QUESTIONNAIRE DURING STUDY VISITS (SAFTEE)
|
20.0%
1/5 • 1 year, 10 months
ADVERSE EVENT COLLECTION BY QUESTIONNAIRE DURING STUDY VISITS (SAFTEE)
|
|
Psychiatric disorders
Walking up in the middle of night
|
0.00%
0/20 • 1 year, 10 months
ADVERSE EVENT COLLECTION BY QUESTIONNAIRE DURING STUDY VISITS (SAFTEE)
|
0.00%
0/20 • 1 year, 10 months
ADVERSE EVENT COLLECTION BY QUESTIONNAIRE DURING STUDY VISITS (SAFTEE)
|
20.0%
1/5 • 1 year, 10 months
ADVERSE EVENT COLLECTION BY QUESTIONNAIRE DURING STUDY VISITS (SAFTEE)
|
|
General disorders
Tiredness
|
0.00%
0/20 • 1 year, 10 months
ADVERSE EVENT COLLECTION BY QUESTIONNAIRE DURING STUDY VISITS (SAFTEE)
|
0.00%
0/20 • 1 year, 10 months
ADVERSE EVENT COLLECTION BY QUESTIONNAIRE DURING STUDY VISITS (SAFTEE)
|
40.0%
2/5 • 1 year, 10 months
ADVERSE EVENT COLLECTION BY QUESTIONNAIRE DURING STUDY VISITS (SAFTEE)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place