Trial Outcomes & Findings for A Randomized Acceptability and Safety Study of Suboxone Induction in Heroin Users (P05042)(COMPLETED) (NCT NCT00604188)
NCT ID: NCT00604188
Last Updated: 2017-07-02
Results Overview
Responders included the number of participants who received the scheduled dose of Suboxone at the Day 3 study visit. Participants who discontinued the study at Day 3 were considered non-responders. All participants that continued the study received Suboxone tablets on Day 3.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
188 participants
Primary outcome timeframe
3 days
Results posted on
2017-07-02
Participant Flow
188 participants were recruited in this study.
188 participants were randomized in the study; however one did not receive any study medication. Therefore the intent-to-treat (ITT) population was 187 participants.
Participant milestones
| Measure |
Direct Suboxone Induction
Participants received 8 mg of Suboxone and placebo Subutex on Day 1, 16 mg of Suboxone and placebo Subutex on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
|
Subutex-to-Suboxone Induction
Participants received 8 mg Subutex and placebo Suboxone on Day 1, 16 mg Subutex and placebo Suboxone on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
|
|---|---|---|
|
Overall Study
STARTED
|
93
|
95
|
|
Overall Study
COMPLETED
|
66
|
70
|
|
Overall Study
NOT COMPLETED
|
27
|
25
|
Reasons for withdrawal
| Measure |
Direct Suboxone Induction
Participants received 8 mg of Suboxone and placebo Subutex on Day 1, 16 mg of Suboxone and placebo Subutex on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
|
Subutex-to-Suboxone Induction
Participants received 8 mg Subutex and placebo Suboxone on Day 1, 16 mg Subutex and placebo Suboxone on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
4
|
|
Overall Study
Lost to Follow-up
|
17
|
15
|
|
Overall Study
Withdrawal by Subject
|
5
|
1
|
|
Overall Study
Non-compliance with protocol
|
4
|
4
|
|
Overall Study
Did not receive study drug
|
0
|
1
|
Baseline Characteristics
A Randomized Acceptability and Safety Study of Suboxone Induction in Heroin Users (P05042)(COMPLETED)
Baseline characteristics by cohort
| Measure |
Direct Suboxone Induction
n=93 Participants
Participants received 8 mg of Suboxone and placebo Subutex on Day 1, 16 mg of Suboxone and placebo Subutex on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
|
Subutex-to-Suboxone Induction
n=94 Participants
Participants received 8 mg Subutex and placebo Suboxone on Day 1, 16 mg Subutex and placebo Suboxone on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
|
Total
n=187 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
31 years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
30.5 years
STANDARD_DEVIATION 8.2 • n=7 Participants
|
30.7 years
STANDARD_DEVIATION 8.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
72 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
141 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 daysPopulation: ITT population
Responders included the number of participants who received the scheduled dose of Suboxone at the Day 3 study visit. Participants who discontinued the study at Day 3 were considered non-responders. All participants that continued the study received Suboxone tablets on Day 3.
Outcome measures
| Measure |
Direct Suboxone Induction
n=93 Participants
Participants received 8 mg of Suboxone and placebo Subutex on Day 1, 16 mg of Suboxone and placebo Subutex on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
|
Subutex-to-Suboxone Induction
n=94 Participants
Participants received 8 mg Subutex and placebo Suboxone on Day 1, 16 mg Subutex and placebo Suboxone on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
|
|---|---|---|
|
Responders at Day 3
Responders
|
85 Participants
|
85 Participants
|
|
Responders at Day 3
Non responders
|
8 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 28 daysPopulation: Participants with missing data were not included in the analysis.
Number of participants who tested negative on UDS during open-label phase on Day 28. The drugs screened on Day 28 included amphetamines, methamphetamines, cocaine, morphine, methadone, benzodiazepines, and tetrahydrocannabinol. Buprenorphine was only tested at screening and randomization according to protocol, therefore no values for buprenorphine are available for Day 28.
Outcome measures
| Measure |
Direct Suboxone Induction
n=79 Participants
Participants received 8 mg of Suboxone and placebo Subutex on Day 1, 16 mg of Suboxone and placebo Subutex on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
|
Subutex-to-Suboxone Induction
n=82 Participants
Participants received 8 mg Subutex and placebo Suboxone on Day 1, 16 mg Subutex and placebo Suboxone on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
|
|---|---|---|
|
Illicit Opioid and Non-opioid Drug Use: Urine Drug Screen (UDS)
Tetrahydrocannabinol
|
65 Participants
|
59 Participants
|
|
Illicit Opioid and Non-opioid Drug Use: Urine Drug Screen (UDS)
Cocaine
|
70 Participants
|
69 Participants
|
|
Illicit Opioid and Non-opioid Drug Use: Urine Drug Screen (UDS)
Amphetamines
|
77 Participants
|
81 Participants
|
|
Illicit Opioid and Non-opioid Drug Use: Urine Drug Screen (UDS)
Benzodiazepines
|
59 Participants
|
64 Participants
|
|
Illicit Opioid and Non-opioid Drug Use: Urine Drug Screen (UDS)
Methamphetamines
|
79 Participants
|
80 Participants
|
|
Illicit Opioid and Non-opioid Drug Use: Urine Drug Screen (UDS)
Morphine
|
66 Participants
|
67 Participants
|
|
Illicit Opioid and Non-opioid Drug Use: Urine Drug Screen (UDS)
Methadone
|
76 Participants
|
81 Participants
|
|
Illicit Opioid and Non-opioid Drug Use: Urine Drug Screen (UDS)
Buprenorphine
|
NA Participants
Per protocol, buprenorphine testing was not performed on Day 28.
|
NA Participants
Per protocol, buprenorphine testing was not performed on Day 28.
|
SECONDARY outcome
Timeframe: Days 3 to 28Population: ITT population
Number of participants with intravenous use of drug as measured by self-reported SUI from Days 3-28. The SUI form consisted of questions addressing the number of days and times a drug was used, and the route of drug use. For suboxone the use of scheduled study medication was not considered illicit use.
Outcome measures
| Measure |
Direct Suboxone Induction
n=93 Participants
Participants received 8 mg of Suboxone and placebo Subutex on Day 1, 16 mg of Suboxone and placebo Subutex on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
|
Subutex-to-Suboxone Induction
n=94 Participants
Participants received 8 mg Subutex and placebo Suboxone on Day 1, 16 mg Subutex and placebo Suboxone on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
|
|---|---|---|
|
Illicit Opioid and Non-opioid Drug Use: Substance Use Inventory (SUI)
Cocaine
|
2 Participants
|
4 Participants
|
|
Illicit Opioid and Non-opioid Drug Use: Substance Use Inventory (SUI)
Subutex - Non prescription source
|
0 Participants
|
0 Participants
|
|
Illicit Opioid and Non-opioid Drug Use: Substance Use Inventory (SUI)
Suboxone - Non prescription source
|
0 Participants
|
0 Participants
|
|
Illicit Opioid and Non-opioid Drug Use: Substance Use Inventory (SUI)
Suboxone - Illicit use from study supplies
|
0 Participants
|
0 Participants
|
|
Illicit Opioid and Non-opioid Drug Use: Substance Use Inventory (SUI)
Heroin
|
12 Participants
|
14 Participants
|
|
Illicit Opioid and Non-opioid Drug Use: Substance Use Inventory (SUI)
Other opioids
|
0 Participants
|
0 Participants
|
|
Illicit Opioid and Non-opioid Drug Use: Substance Use Inventory (SUI)
Methadone
|
0 Participants
|
0 Participants
|
|
Illicit Opioid and Non-opioid Drug Use: Substance Use Inventory (SUI)
Methamphetamine
|
0 Participants
|
0 Participants
|
|
Illicit Opioid and Non-opioid Drug Use: Substance Use Inventory (SUI)
Benzodiazepines/Tranquilizers
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline and 28 daysPopulation: Participants with SOWS data reviewed for completeness and within visit date consistency were analyzed.
SOWS were 16 items whose intensity was scored on a scale from 0 (not at all) to 4 (extremely) for a maximum possible score of 64. A total score of 0 represented the best outcome and a score of 64 represented the worst outcome. Participants were scored for SOWS at baseline (prior to randomization) and on Day 28. Reported are the scores for Day 28, and the change in scores from baseline to Day 28.
Outcome measures
| Measure |
Direct Suboxone Induction
n=69 Participants
Participants received 8 mg of Suboxone and placebo Subutex on Day 1, 16 mg of Suboxone and placebo Subutex on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
|
Subutex-to-Suboxone Induction
n=72 Participants
Participants received 8 mg Subutex and placebo Suboxone on Day 1, 16 mg Subutex and placebo Suboxone on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
|
|---|---|---|
|
Self-reported Opioid Withdrawal Symptoms (SOWS)
Score on Day 28
|
3.8 Score on a scale
Standard Deviation 6.77
|
3.4 Score on a scale
Standard Deviation 5.95
|
|
Self-reported Opioid Withdrawal Symptoms (SOWS)
Change from Baseline to Day 28
|
-23.3 Score on a scale
Standard Deviation 14.1
|
-21.9 Score on a scale
Standard Deviation 13.4
|
SECONDARY outcome
Timeframe: Baseline and 28 daysPopulation: Participants with OOWS data reviewed for completeness and within visit date consistency were analyzed.
The OOWS were 13 physically observable signs that were present (scored 1) or absent (scored 0). A total score of 0 represented the best outcome and a total score of 13 represented the worst outcome. Participants were scored for OOWS at baseline (prior to randomization) and on Day 28. Reported are the total score for Day 28, and the change in scores from baseline to Day 28.
Outcome measures
| Measure |
Direct Suboxone Induction
n=69 Participants
Participants received 8 mg of Suboxone and placebo Subutex on Day 1, 16 mg of Suboxone and placebo Subutex on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
|
Subutex-to-Suboxone Induction
n=72 Participants
Participants received 8 mg Subutex and placebo Suboxone on Day 1, 16 mg Subutex and placebo Suboxone on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
|
|---|---|---|
|
Observer-rated Opioid Withdrawal Symptoms (OOWS)
OOWS Score on Day 28
|
0.6 Score on a scale
Standard Deviation 1.36
|
0.5 Score on a scale
Standard Deviation 0.87
|
|
Observer-rated Opioid Withdrawal Symptoms (OOWS)
Change from Baseline
|
-5.9 Score on a scale
Standard Deviation 3.19
|
-5.9 Score on a scale
Standard Deviation 3.24
|
SECONDARY outcome
Timeframe: Baseline and 28 daysPopulation: ITT population.
The ASI-Lite is a standardized, multidimensional, semi-structured, comprehensive interview that estimates addiction-related problem severity profiles in seven domains commonly affected in substance abusers. ASI-lite composite score ranges from 0 (worst outcome) to 1 (best outcome) for each category. Reported here is the change in ASI-Lite from baseline to Day 28. The original drug use accounts for heroin, methadone, other opiates, analgesics, medicine/pills, cocaine, amphetamines, cannabis, hallucinogens, and inhalants. Modified drug use accounts for heroin, methadone, cocaine, and cannabis.
Outcome measures
| Measure |
Direct Suboxone Induction
n=93 Participants
Participants received 8 mg of Suboxone and placebo Subutex on Day 1, 16 mg of Suboxone and placebo Subutex on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
|
Subutex-to-Suboxone Induction
n=94 Participants
Participants received 8 mg Subutex and placebo Suboxone on Day 1, 16 mg Subutex and placebo Suboxone on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
|
|---|---|---|
|
Addiction-related Severity Index (ASI-Lite): A Composite Score to Evaluate Seven Potential Problem Areas: Medical, Employment/Support Status, Alcohol, Drug, Legal, Family/Social, and Psychiatric
Medical
|
-0.05 Score on a scale
Standard Error 0.027
|
-0.05 Score on a scale
Standard Error 0.027
|
|
Addiction-related Severity Index (ASI-Lite): A Composite Score to Evaluate Seven Potential Problem Areas: Medical, Employment/Support Status, Alcohol, Drug, Legal, Family/Social, and Psychiatric
Employment
|
-0.04 Score on a scale
Standard Error 0.034
|
-0.02 Score on a scale
Standard Error 0.033
|
|
Addiction-related Severity Index (ASI-Lite): A Composite Score to Evaluate Seven Potential Problem Areas: Medical, Employment/Support Status, Alcohol, Drug, Legal, Family/Social, and Psychiatric
Employment satisfaction
|
-0.10 Score on a scale
Standard Error 0.030
|
-0.01 Score on a scale
Standard Error 0.029
|
|
Addiction-related Severity Index (ASI-Lite): A Composite Score to Evaluate Seven Potential Problem Areas: Medical, Employment/Support Status, Alcohol, Drug, Legal, Family/Social, and Psychiatric
Alcohol use
|
-0.03 Score on a scale
Standard Error 0.017
|
-0.01 Score on a scale
Standard Error 0.017
|
|
Addiction-related Severity Index (ASI-Lite): A Composite Score to Evaluate Seven Potential Problem Areas: Medical, Employment/Support Status, Alcohol, Drug, Legal, Family/Social, and Psychiatric
Drug use (Original)
|
-0.24 Score on a scale
Standard Error 0.018
|
-0.23 Score on a scale
Standard Error 0.017
|
|
Addiction-related Severity Index (ASI-Lite): A Composite Score to Evaluate Seven Potential Problem Areas: Medical, Employment/Support Status, Alcohol, Drug, Legal, Family/Social, and Psychiatric
Drug use (Modified)
|
-0.36 Score on a scale
Standard Error 0.021
|
-0.34 Score on a scale
Standard Error 0.021
|
|
Addiction-related Severity Index (ASI-Lite): A Composite Score to Evaluate Seven Potential Problem Areas: Medical, Employment/Support Status, Alcohol, Drug, Legal, Family/Social, and Psychiatric
Legal status
|
-0.09 Score on a scale
Standard Error 0.026
|
-0.08 Score on a scale
Standard Error 0.025
|
|
Addiction-related Severity Index (ASI-Lite): A Composite Score to Evaluate Seven Potential Problem Areas: Medical, Employment/Support Status, Alcohol, Drug, Legal, Family/Social, and Psychiatric
Family/Social relations
|
-0.10 Score on a scale
Standard Error 0.040
|
-0.10 Score on a scale
Standard Error 0.041
|
|
Addiction-related Severity Index (ASI-Lite): A Composite Score to Evaluate Seven Potential Problem Areas: Medical, Employment/Support Status, Alcohol, Drug, Legal, Family/Social, and Psychiatric
Other Family/Social relations
|
-0.08 Score on a scale
Standard Error 0.027
|
-0.06 Score on a scale
Standard Error 0.026
|
|
Addiction-related Severity Index (ASI-Lite): A Composite Score to Evaluate Seven Potential Problem Areas: Medical, Employment/Support Status, Alcohol, Drug, Legal, Family/Social, and Psychiatric
Psychiatric
|
-0.12 Score on a scale
Standard Error 0.025
|
-0.08 Score on a scale
Standard Error 0.024
|
SECONDARY outcome
Timeframe: 28 daysPopulation: ITT population
Compliance rate was calculated as the number of days study medication was taken divided by the number of days study medication should have been taken X 100. The number of days study medication should have been taken was equal to the duration of treatment.
Outcome measures
| Measure |
Direct Suboxone Induction
n=93 Participants
Participants received 8 mg of Suboxone and placebo Subutex on Day 1, 16 mg of Suboxone and placebo Subutex on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
|
Subutex-to-Suboxone Induction
n=94 Participants
Participants received 8 mg Subutex and placebo Suboxone on Day 1, 16 mg Subutex and placebo Suboxone on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
|
|---|---|---|
|
Compliance Rate
|
98.7 Percentage of days
Standard Deviation 4.22
|
98.4 Percentage of days
Standard Deviation 6.25
|
SECONDARY outcome
Timeframe: 28 daysPopulation: ITT population
Responders were the number of participants in each group who received the scheduled 8- to 24-mg dose of Suboxone at study visit day. A participant who discontinued from the study was treated as a non-responder at the timepoint after the participant discontinued.
Outcome measures
| Measure |
Direct Suboxone Induction
n=93 Participants
Participants received 8 mg of Suboxone and placebo Subutex on Day 1, 16 mg of Suboxone and placebo Subutex on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
|
Subutex-to-Suboxone Induction
n=94 Participants
Participants received 8 mg Subutex and placebo Suboxone on Day 1, 16 mg Subutex and placebo Suboxone on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
|
|---|---|---|
|
Responders at Day 28
Responder
|
46 Participants
|
55 Participants
|
|
Responders at Day 28
Non-responder
|
47 Participants
|
39 Participants
|
Adverse Events
Direct Suboxone Induction
Serious events: 1 serious events
Other events: 61 other events
Deaths: 0 deaths
Subutex-to-Suboxone Induction
Serious events: 3 serious events
Other events: 64 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Direct Suboxone Induction
n=93 participants at risk
Participants received 8 mg of Suboxone and placebo Subutex on Day 1, 16 mg of Suboxone and placebo Subutex on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
|
Subutex-to-Suboxone Induction
n=94 participants at risk
Participants received 8 mg Subutex and placebo Suboxone on Day 1, 16 mg Subutex and placebo Suboxone on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
|
|---|---|---|
|
Infections and infestations
ABSCESS LIMB
|
0.00%
0/93
The population analyzed is the ITT population
|
1.1%
1/94 • Number of events 1
The population analyzed is the ITT population
|
|
Nervous system disorders
EPILEPSY
|
0.00%
0/93
The population analyzed is the ITT population
|
1.1%
1/94 • Number of events 1
The population analyzed is the ITT population
|
|
Psychiatric disorders
DEPRESSION
|
1.1%
1/93 • Number of events 1
The population analyzed is the ITT population
|
0.00%
0/94
The population analyzed is the ITT population
|
|
Psychiatric disorders
DRUG DEPENDENCE
|
1.1%
1/93 • Number of events 1
The population analyzed is the ITT population
|
0.00%
0/94
The population analyzed is the ITT population
|
|
Psychiatric disorders
PERSONALITY DISORDER
|
1.1%
1/93 • Number of events 1
The population analyzed is the ITT population
|
0.00%
0/94
The population analyzed is the ITT population
|
|
Skin and subcutaneous tissue disorders
RASH
|
0.00%
0/93
The population analyzed is the ITT population
|
1.1%
1/94 • Number of events 1
The population analyzed is the ITT population
|
Other adverse events
| Measure |
Direct Suboxone Induction
n=93 participants at risk
Participants received 8 mg of Suboxone and placebo Subutex on Day 1, 16 mg of Suboxone and placebo Subutex on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
|
Subutex-to-Suboxone Induction
n=94 participants at risk
Participants received 8 mg Subutex and placebo Suboxone on Day 1, 16 mg Subutex and placebo Suboxone on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
|
|---|---|---|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
5.4%
5/93 • Number of events 5
The population analyzed is the ITT population
|
4.3%
4/94 • Number of events 5
The population analyzed is the ITT population
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
1.1%
1/93 • Number of events 1
The population analyzed is the ITT population
|
6.4%
6/94 • Number of events 7
The population analyzed is the ITT population
|
|
Gastrointestinal disorders
NAUSEA
|
8.6%
8/93 • Number of events 9
The population analyzed is the ITT population
|
14.9%
14/94 • Number of events 15
The population analyzed is the ITT population
|
|
Gastrointestinal disorders
TOOTHACHE
|
6.5%
6/93 • Number of events 6
The population analyzed is the ITT population
|
1.1%
1/94 • Number of events 1
The population analyzed is the ITT population
|
|
Gastrointestinal disorders
VOMITING
|
16.1%
15/93 • Number of events 16
The population analyzed is the ITT population
|
11.7%
11/94 • Number of events 12
The population analyzed is the ITT population
|
|
General disorders
ASTHENIA
|
8.6%
8/93 • Number of events 8
The population analyzed is the ITT population
|
5.3%
5/94 • Number of events 6
The population analyzed is the ITT population
|
|
General disorders
CHILLS
|
3.2%
3/93 • Number of events 3
The population analyzed is the ITT population
|
6.4%
6/94 • Number of events 6
The population analyzed is the ITT population
|
|
General disorders
FEELING COLD
|
7.5%
7/93 • Number of events 7
The population analyzed is the ITT population
|
10.6%
10/94 • Number of events 10
The population analyzed is the ITT population
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
7.5%
7/93 • Number of events 8
The population analyzed is the ITT population
|
11.7%
11/94 • Number of events 12
The population analyzed is the ITT population
|
|
Nervous system disorders
HEADACHE
|
7.5%
7/93 • Number of events 10
The population analyzed is the ITT population
|
9.6%
9/94 • Number of events 10
The population analyzed is the ITT population
|
|
Nervous system disorders
SOMNOLENCE
|
10.8%
10/93 • Number of events 11
The population analyzed is the ITT population
|
7.4%
7/94 • Number of events 9
The population analyzed is the ITT population
|
|
Psychiatric disorders
ANXIETY
|
20.4%
19/93 • Number of events 24
The population analyzed is the ITT population
|
17.0%
16/94 • Number of events 17
The population analyzed is the ITT population
|
|
Psychiatric disorders
DRUG DEPENDENCE
|
17.2%
16/93 • Number of events 20
The population analyzed is the ITT population
|
10.6%
10/94 • Number of events 15
The population analyzed is the ITT population
|
|
Psychiatric disorders
INSOMNIA
|
26.9%
25/93 • Number of events 27
The population analyzed is the ITT population
|
27.7%
26/94 • Number of events 30
The population analyzed is the ITT population
|
|
Psychiatric disorders
RESTLESSNESS
|
8.6%
8/93 • Number of events 8
The population analyzed is the ITT population
|
5.3%
5/94 • Number of events 6
The population analyzed is the ITT population
|
|
Respiratory, thoracic and mediastinal disorders
RHINORRHOEA
|
7.5%
7/93 • Number of events 7
The population analyzed is the ITT population
|
5.3%
5/94 • Number of events 5
The population analyzed is the ITT population
|
|
Skin and subcutaneous tissue disorders
HYPERHIDROSIS
|
23.7%
22/93 • Number of events 25
The population analyzed is the ITT population
|
22.3%
21/94 • Number of events 25
The population analyzed is the ITT population
|
|
Vascular disorders
HOT FLUSH
|
5.4%
5/93 • Number of events 5
The population analyzed is the ITT population
|
4.3%
4/94 • Number of events 5
The population analyzed is the ITT population
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The disclosure restriction on the PI cannot publish an individual study until a publication disclosing results from multicenter studies is published. The sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 45 days from the time submitted to the sponsor for review.
- Publication restrictions are in place
Restriction type: OTHER