Trial Outcomes & Findings for Discontinuation vs Continuation of Long-term Opioid Therapy in Suboptimal and Optimal Responders With Chronic Pain (NCT NCT02741076)
NCT ID: NCT02741076
Last Updated: 2019-11-06
Results Overview
Baseline is defined as the mean of the available Average PI scores on the 0-10 Numerical Ratings Scale (NRS) over the 7-day Baseline Period. For the scheduled post-randomization visits, mean Average Pain Intensity is defined as the means of the respective PI scores over the 7 days preceding the visit. If there is only one daily PI score available, the mean is not calculated, and the data point is considered missing. PI = Pain Intensity. Higher scores indicate more pain intensity; lower scores less pain intensity. Scale range 0-10.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
44 participants
Primary outcome timeframe
From baseline to the 1 week period prior to the Week 12 visit
Results posted on
2019-11-06
Participant Flow
First Subject First Visit 14 September 2016; Date of Early Study Termination 29 January 2018
Prior to randomization, subjects gave consent and entered a pre-assignment period that assessed eligibility for the intervention phase of the study.
Participant milestones
| Measure |
Structured Discontinuation Opioid Therapy Suboptimal Responder
Structured discontinuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER) Suboptimal Responder
|
Continuation of Opioid Therapy Suboptimal Responder
Structured continuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER), Suboptimal Responder
|
Structured Discontinuation Opioid Therapy Optimal Responder
Structured discontinuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER), Optimal Responder
|
Continuation of Opioid Therapy Optimal Responder
Structured continuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER), Optimal Responder
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
13
|
12
|
3
|
4
|
|
Overall Study
COMPLETED
|
10
|
7
|
1
|
2
|
|
Overall Study
NOT COMPLETED
|
3
|
5
|
2
|
2
|
Reasons for withdrawal
| Measure |
Structured Discontinuation Opioid Therapy Suboptimal Responder
Structured discontinuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER) Suboptimal Responder
|
Continuation of Opioid Therapy Suboptimal Responder
Structured continuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER), Suboptimal Responder
|
Structured Discontinuation Opioid Therapy Optimal Responder
Structured discontinuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER), Optimal Responder
|
Continuation of Opioid Therapy Optimal Responder
Structured continuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER), Optimal Responder
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
1
|
0
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
|
Overall Study
Sponsor Request
|
2
|
3
|
0
|
1
|
|
Overall Study
No additional information available
|
0
|
0
|
1
|
1
|
Baseline Characteristics
Discontinuation vs Continuation of Long-term Opioid Therapy in Suboptimal and Optimal Responders With Chronic Pain
Baseline characteristics by cohort
| Measure |
Structured Discontinuation Opioid Therapy Suboptimal Responder
n=13 Participants
Structured discontinuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER), Suboptimal Responder
|
Continuation of Opioid Therapy Suboptimal Responder
n=12 Participants
Structured continuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER), Suboptimal Responder
|
Structured Discontinuation Opioid Therapy Optimal Responder
n=3 Participants
Structured discontinuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER), Optimal Responder
|
Continuation of Opioid Therapy Optimal Responder
n=4 Participants
Structured continuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER), Optimal Responder
|
Total
n=32 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
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Age, Continuous
|
56.5 years
n=5 Participants
|
56.1 years
n=7 Participants
|
41.7 years
n=5 Participants
|
49.8 years
n=4 Participants
|
54.1 years
n=21 Participants
|
|
Age, Customized
<25
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Customized
25-49
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Age, Customized
50-64
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
|
Age, Customized
Equal to or greater than 65
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=5 Participants
|
12 participants
n=7 Participants
|
3 participants
n=5 Participants
|
4 participants
n=4 Participants
|
32 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: From baseline to the 1 week period prior to the Week 12 visitPopulation: Intent to Treat Population
Baseline is defined as the mean of the available Average PI scores on the 0-10 Numerical Ratings Scale (NRS) over the 7-day Baseline Period. For the scheduled post-randomization visits, mean Average Pain Intensity is defined as the means of the respective PI scores over the 7 days preceding the visit. If there is only one daily PI score available, the mean is not calculated, and the data point is considered missing. PI = Pain Intensity. Higher scores indicate more pain intensity; lower scores less pain intensity. Scale range 0-10.
Outcome measures
| Measure |
Structured Discontinuation Opioid Therapy Suboptimal Responder
n=13 Participants
Structured discontinuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER), Suboptimal Responder
|
Continuation of Opioid Therapy Suboptimal Responder
n=12 Participants
Structured continuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER), Suboptimal Responder
|
Structured Discontinuation Opioid Therapy Optimal Responder
n=3 Participants
Structured discontinuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER), Optimal Responder
|
Continuation of Opioid Therapy Optimal Responder
n=4 Participants
Structured continuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER), Optimal Responder
|
|---|---|---|---|---|
|
Change in the Mean Average Pain Intensity (PI) Score on the 0-10 Numerical Ratings Scale (NRS)
|
-0.2198 Score on a scale
Standard Deviation 0.83544
|
-0.3328 Score on a scale
Standard Deviation 1.00514
|
0.3750 Score on a scale
Standard Deviation 1.28794
|
1.00 Score on a scale
Standard Deviation 0.00
|
SECONDARY outcome
Timeframe: From baseline to weeks 4, 8, 16, 20, and 24Population: Intent to Treat Population
Baseline is defined as the mean of the available Average PI scores on the 0-10 Numerical Ratings Scale (NRS) over the 7-day Baseline Period. For the scheduled post-randomization visits, mean Average Pain Intensity is defined as the means of the respective PI scores over the 7 days preceding the visit. If there is only one daily PI score available, the mean is not calculated, and the data point is considered missing. PI = Pain Intensity. Higher scores indicate more pain intensity; lower scores less pain intensity. Scale range 0-10.
Outcome measures
| Measure |
Structured Discontinuation Opioid Therapy Suboptimal Responder
n=13 Participants
Structured discontinuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER), Suboptimal Responder
|
Continuation of Opioid Therapy Suboptimal Responder
n=12 Participants
Structured continuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER), Suboptimal Responder
|
Structured Discontinuation Opioid Therapy Optimal Responder
n=3 Participants
Structured discontinuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER), Optimal Responder
|
Continuation of Opioid Therapy Optimal Responder
n=4 Participants
Structured continuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER), Optimal Responder
|
|---|---|---|---|---|
|
Change in Mean Average Pain Intensity Score (PI) Score on the 0-10 Numerical Ratings Scale (NRS)
4 weeks
|
-0.1123 Score on a scale
Standard Deviation 0.77962
|
-0.1413 Score on a scale
Standard Deviation 0.99386
|
0.4940 Score on a scale
Standard Deviation 0.64818
|
0.3143 Score on a scale
Standard Deviation 0.38951
|
|
Change in Mean Average Pain Intensity Score (PI) Score on the 0-10 Numerical Ratings Scale (NRS)
8 weeks
|
-0.3671 Score on a scale
Standard Deviation 0.86810
|
0.0984 Score on a scale
Standard Deviation 0.62794
|
0.3393 Score on a scale
Standard Deviation 0.63135
|
0.1413 Score on a scale
Standard Deviation 0.25046
|
|
Change in Mean Average Pain Intensity Score (PI) Score on the 0-10 Numerical Ratings Scale (NRS)
16 weeks
|
-0.3462 Score on a scale
Standard Deviation 0.79086
|
-0.5714 Score on a scale
Standard Deviation 1.37382
|
-0.6964 Score on a scale
Standard Deviation 1.38896
|
0.4508 Score on a scale
Standard Deviation 0.48807
|
|
Change in Mean Average Pain Intensity Score (PI) Score on the 0-10 Numerical Ratings Scale (NRS)
20 weeks
|
-0.4153 Score on a scale
Standard Deviation 0.81486
|
-0.6873 Score on a scale
Standard Deviation 1.08941
|
-0.4821 Score on a scale
Standard Deviation 1.08591
|
-0.3095 Score on a scale
Standard Deviation 0.03367
|
|
Change in Mean Average Pain Intensity Score (PI) Score on the 0-10 Numerical Ratings Scale (NRS)
24 weeks
|
-0.5000 Score on a scale
Standard Deviation 0.83692
|
-0.1532 Score on a scale
Standard Deviation 1.23299
|
0.2857 Score on a scale
Standard Deviation NA
Not estimable due to single subject in group
|
1.5 Score on a scale
Standard Deviation NA
Not estimable due to single subject in group
|
SECONDARY outcome
Timeframe: Weeks 12 and 24Population: Intent to Treat Population
Percent pain intensity difference (PID) relative to baseline is defined as 100\* ((baseline Average PI - mean Average PI at visit)/baseline Average PI). The percentages are based on number of subjects in the Intent-to-Treat set per treatment group. PI is measured on the Numerical Ratings Scale (NRS). Higher scores indicate more pain intensity; lower scores less pain intensity. Scale range 0-10. This outcome measure applies only to Suboptimal Responders.
Outcome measures
| Measure |
Structured Discontinuation Opioid Therapy Suboptimal Responder
n=13 Participants
Structured discontinuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER), Suboptimal Responder
|
Continuation of Opioid Therapy Suboptimal Responder
n=12 Participants
Structured continuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER), Suboptimal Responder
|
Structured Discontinuation Opioid Therapy Optimal Responder
Structured discontinuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER), Optimal Responder
|
Continuation of Opioid Therapy Optimal Responder
Structured continuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER), Optimal Responder
|
|---|---|---|---|---|
|
Number of Suboptimal Responders With Pain Intensity (PI) Score Improvement Relative to Baseline PI Measured on the 0-10 Numerical Ratings Scale (NRS)
greater than or equal to 30% Week 12
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Suboptimal Responders With Pain Intensity (PI) Score Improvement Relative to Baseline PI Measured on the 0-10 Numerical Ratings Scale (NRS)
greater than or equal to 20% Week 12
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Suboptimal Responders With Pain Intensity (PI) Score Improvement Relative to Baseline PI Measured on the 0-10 Numerical Ratings Scale (NRS)
greater than or equal to 10% Week 12
|
3 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Suboptimal Responders With Pain Intensity (PI) Score Improvement Relative to Baseline PI Measured on the 0-10 Numerical Ratings Scale (NRS)
>0% (any improvement) Week 12
|
7 Participants
|
5 Participants
|
0 Participants
|
0 Participants
|
|
Number of Suboptimal Responders With Pain Intensity (PI) Score Improvement Relative to Baseline PI Measured on the 0-10 Numerical Ratings Scale (NRS)
greater than or equal to 30% Week 24
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Suboptimal Responders With Pain Intensity (PI) Score Improvement Relative to Baseline PI Measured on the 0-10 Numerical Ratings Scale (NRS)
greater than or equal to 20% Week 24
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Suboptimal Responders With Pain Intensity (PI) Score Improvement Relative to Baseline PI Measured on the 0-10 Numerical Ratings Scale (NRS)
greater than or equal to 10% Week 24
|
5 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Suboptimal Responders With Pain Intensity (PI) Score Improvement Relative to Baseline PI Measured on the 0-10 Numerical Ratings Scale (NRS)
>0% (any improvement) Week 24
|
8 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Weeks 12 and 24Population: Intent to Treat Population
Percent pain intensity difference (PID) relative to baseline is defined as 100\* ((baseline Average PI - mean Average PI at visit)/baseline Average PI). The percentages are based on number of subjects in the Intent-to-Treat set per treatment group. PI is measured on the Numerical Ratings Scale (NRS). Higher scores indicate more pain intensity; lower scores less pain intensity. Scale range 0-10. This outcome measure applies only to Optimal Responders.
Outcome measures
| Measure |
Structured Discontinuation Opioid Therapy Suboptimal Responder
Structured discontinuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER), Suboptimal Responder
|
Continuation of Opioid Therapy Suboptimal Responder
Structured continuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER), Suboptimal Responder
|
Structured Discontinuation Opioid Therapy Optimal Responder
n=3 Participants
Structured discontinuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER), Optimal Responder
|
Continuation of Opioid Therapy Optimal Responder
n=4 Participants
Structured continuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER), Optimal Responder
|
|---|---|---|---|---|
|
Number of Suboptimal Responders With Pain Intensity (PI) Score Worsening Relative to Baseline PI Measured on the 0-10 Numerical Ratings Scale (NRS)
Greater than or equal to 10% Week 24
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Suboptimal Responders With Pain Intensity (PI) Score Worsening Relative to Baseline PI Measured on the 0-10 Numerical Ratings Scale (NRS)
greater than or equal to 40% Week 12
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Suboptimal Responders With Pain Intensity (PI) Score Worsening Relative to Baseline PI Measured on the 0-10 Numerical Ratings Scale (NRS)
Greater than or equal to 30% Week 12
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Suboptimal Responders With Pain Intensity (PI) Score Worsening Relative to Baseline PI Measured on the 0-10 Numerical Ratings Scale (NRS)
greater than or equal to 20% Week 12
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Suboptimal Responders With Pain Intensity (PI) Score Worsening Relative to Baseline PI Measured on the 0-10 Numerical Ratings Scale (NRS)
Greater than or equal to 10% Week 12
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Suboptimal Responders With Pain Intensity (PI) Score Worsening Relative to Baseline PI Measured on the 0-10 Numerical Ratings Scale (NRS)
Equal to 0% (any worsening) Week 12
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Suboptimal Responders With Pain Intensity (PI) Score Worsening Relative to Baseline PI Measured on the 0-10 Numerical Ratings Scale (NRS)
Greater than or equal to 40% week 24
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Suboptimal Responders With Pain Intensity (PI) Score Worsening Relative to Baseline PI Measured on the 0-10 Numerical Ratings Scale (NRS)
greater than or equal to 30% Week 24
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Suboptimal Responders With Pain Intensity (PI) Score Worsening Relative to Baseline PI Measured on the 0-10 Numerical Ratings Scale (NRS)
greater than or equal to 20% Week 24
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Suboptimal Responders With Pain Intensity (PI) Score Worsening Relative to Baseline PI Measured on the 0-10 Numerical Ratings Scale (NRS)
Greater than 0% (any worsening) Week 24
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Weeks 12 and 24Population: Intent to Treat Population
The MOS Sleep Scale is a 12-item questionnaire which measures sleep quality in 7 scales over the past 4 weeks: sleep disturbance, snoring, sleep short of breath or headache, sleep adequacy, sleep somnolence, and 2 sleep problems indexes. In addition, the average hours of sleep over the past 4 weeks is recorded as a raw measure and also coded as an optimal sleep index. The MOS is scored and the sleep scales calculated according to the MOS Sleep Scale User's Manual v1.0 (Spritzer and Hays, 2003). The scores on the dimensions and the sleep indices were converted to a 0-100 scale, with higher scores reflecting more of the attribute implied by the name (e.g. greater sleep disturbance, greater sleep adequacy of sleep).
Outcome measures
| Measure |
Structured Discontinuation Opioid Therapy Suboptimal Responder
n=13 Participants
Structured discontinuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER), Suboptimal Responder
|
Continuation of Opioid Therapy Suboptimal Responder
n=12 Participants
Structured continuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER), Suboptimal Responder
|
Structured Discontinuation Opioid Therapy Optimal Responder
n=3 Participants
Structured discontinuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER), Optimal Responder
|
Continuation of Opioid Therapy Optimal Responder
n=4 Participants
Structured continuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER), Optimal Responder
|
|---|---|---|---|---|
|
Change From Baseline on Sleep Quality Measured by Medical Outcomes Study (MOS)
Sleep Disturbance Week 12
|
-5.673 Score on a scale
Standard Deviation 18.5378
|
-5.00 Score on a scale
Standard Deviation 35.3754
|
-0.417 Score on a scale
Standard Deviation 8.3229
|
2.813 Score on a scale
Standard Deviation 16.5635
|
|
Change From Baseline on Sleep Quality Measured by Medical Outcomes Study (MOS)
Snoring Week 12
|
0.00 Score on a scale
Standard Deviation 37.42
|
10.00 Score on a scale
Standard Deviation 27.63
|
0.00 Score on a scale
Standard Deviation 40.00
|
15.00 Score on a scale
Standard Deviation 19.15
|
|
Change From Baseline on Sleep Quality Measured by Medical Outcomes Study (MOS)
Awaken Short of Breath or Headache Week 12
|
3.1 Score on a scale
Standard Deviation 21.36
|
0.00 Score on a scale
Standard Deviation 26.97
|
13.3 Score on a scale
Standard Deviation 23.09
|
10.00 Score on a scale
Standard Deviation 11.55
|
|
Change From Baseline on Sleep Quality Measured by Medical Outcomes Study (MOS)
Sleep Adequacy Week 12
|
10.00 Score on a scale
Standard Deviation 18.26
|
0.8 Score on a scale
Standard Deviation 24.29
|
3.3 Score on a scale
Standard Deviation 25.17
|
5.00 Score on a scale
Standard Deviation 19.15
|
|
Change From Baseline on Sleep Quality Measured by Medical Outcomes Study (MOS)
Sleep Somnolence Week 12
|
-4.6154 Score on a scale
Standard Deviation 20.43683
|
2.7778 Score on a scale
Standard Deviation 25.33945
|
6.6667 Score on a scale
Standard Deviation 17.63834
|
8.3333 Score on a scale
Standard Deviation 14.78237
|
|
Change From Baseline on Sleep Quality Measured by Medical Outcomes Study (MOS)
Sleep Problems Index I Week 12
|
-4.1026 Score on a scale
Standard Deviation 12.25907
|
-0.2778 Score on a scale
Standard Deviation 16.66414
|
4.4444 Score on a scale
Standard Deviation 12.61980
|
0.8333 Score on a scale
Standard Deviation 9.95360
|
|
Change From Baseline on Sleep Quality Measured by Medical Outcomes Study (MOS)
Sleep Problems Index II Week 12
|
-5.4274 Score on a scale
Standard Deviation 13.32784
|
-2.222 Score on a scale
Standard Deviation 15.63651
|
2.0370 Score on a scale
Standard Deviation 15.23816
|
1.8056 Score on a scale
Standard Deviation 12.50823
|
|
Change From Baseline on Sleep Quality Measured by Medical Outcomes Study (MOS)
Sleep Quantity Week 12
|
0.1 Score on a scale
Standard Deviation 0.95
|
-0.1 Score on a scale
Standard Deviation 1.31
|
-2.3 Score on a scale
Standard Deviation 2.89
|
0.5 Score on a scale
Standard Deviation 0.58
|
|
Change From Baseline on Sleep Quality Measured by Medical Outcomes Study (MOS)
Sleep Disturbance Week 24
|
5.375 Score on a scale
Standard Deviation 18.4283
|
-10.313 Score on a scale
Standard Deviation 12.4418
|
-5.00 Score on a scale
Standard Deviation 14.1421
|
-10.000 Score on a scale
Standard Deviation 3.7500
|
|
Change From Baseline on Sleep Quality Measured by Medical Outcomes Study (MOS)
Snoring Week 24
|
0.0 Score on a scale
Standard Deviation 42.16
|
0.0 Score on a scale
Standard Deviation 38.54
|
40.00 Score on a scale
Standard Deviation 28.28
|
13.3 Score on a scale
Standard Deviation 11.55
|
|
Change From Baseline on Sleep Quality Measured by Medical Outcomes Study (MOS)
Awaken Short of Breath or Headache Week 24
|
10.0 Score on a scale
Standard Deviation 34.32
|
10.0 Score on a scale
Standard Deviation 41.40
|
20.0 Score on a scale
Standard Deviation 28.28
|
40.00 Score on a scale
Standard Deviation 40.00
|
|
Change From Baseline on Sleep Quality Measured by Medical Outcomes Study (MOS)
Sleep Adequacy Week 24
|
0.0 Score on a scale
Standard Deviation 35.28
|
13.8 Score on a scale
Standard Deviation 19.23
|
25.0 Score on a scale
Standard Deviation 21.21
|
0.00 Score on a scale
Standard Deviation 20.00
|
|
Change From Baseline on Sleep Quality Measured by Medical Outcomes Study (MOS)
Sleep Somnolence Week 24
|
6.0000 Score on a scale
Standard Deviation 33.47378
|
-4.1667 Score on a scale
Standard Deviation 24.92847
|
16.6667 Score on a scale
Standard Deviation 32.99832
|
-11.1111 Score on a scale
Standard Deviation 7.69800
|
|
Change From Baseline on Sleep Quality Measured by Medical Outcomes Study (MOS)
Sleep Problems Index I Week 24
|
6.6667 Score on a scale
Standard Deviation 25.09242
|
-9.1667 Score on a scale
Standard Deviation 20.91176
|
-6.6667 Score on a scale
Standard Deviation 18.85618
|
-2.2222 Score on a scale
Standard Deviation 11.70628
|
|
Change From Baseline on Sleep Quality Measured by Medical Outcomes Study (MOS)
Sleep Problems Index II Week 24
|
4.8333 Score on a scale
Standard Deviation 22.91520
|
-6.8056 Score on a scale
Standard Deviation 17.25100
|
-2.2222 Score on a scale
Standard Deviation 21.99888
|
-2.2222 Score on a scale
Standard Deviation 6.40698
|
|
Change From Baseline on Sleep Quality Measured by Medical Outcomes Study (MOS)
Sleep Quantity Week 24
|
-0.8 Score on a scale
Standard Deviation 1.81
|
-0.1 Score on a scale
Standard Deviation 1.46
|
0.5 Score on a scale
Standard Deviation 0.71
|
0.0 Score on a scale
Standard Deviation 0.00
|
SECONDARY outcome
Timeframe: 4 weeks prior to baseline and prior to 12 and 24 week visitsPopulation: Intent to Treat Population
Optimal Sleep Index is based on the average number of hours of sleep each night during the past 4 weeks. Index=1 represents 7-8 hours and Index=0 represents \< 7 hours or \> 8 hours.
Outcome measures
| Measure |
Structured Discontinuation Opioid Therapy Suboptimal Responder
n=13 Participants
Structured discontinuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER), Suboptimal Responder
|
Continuation of Opioid Therapy Suboptimal Responder
n=12 Participants
Structured continuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER), Suboptimal Responder
|
Structured Discontinuation Opioid Therapy Optimal Responder
n=3 Participants
Structured discontinuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER), Optimal Responder
|
Continuation of Opioid Therapy Optimal Responder
n=4 Participants
Structured continuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER), Optimal Responder
|
|---|---|---|---|---|
|
Participants Sleep Quantity Measured by Medical Outcomes Study (MOS)
Index=0 Baseline
|
10 Participants
|
9 Participants
|
2 Participants
|
3 Participants
|
|
Participants Sleep Quantity Measured by Medical Outcomes Study (MOS)
Index=1 Baseline
|
3 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
|
Participants Sleep Quantity Measured by Medical Outcomes Study (MOS)
Index=0 Week 12
|
11 Participants
|
10 Participants
|
2 Participants
|
1 Participants
|
|
Participants Sleep Quantity Measured by Medical Outcomes Study (MOS)
Index=1 Week 12
|
2 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
|
Participants Sleep Quantity Measured by Medical Outcomes Study (MOS)
Index=0 Week 24
|
9 Participants
|
7 Participants
|
1 Participants
|
2 Participants
|
|
Participants Sleep Quantity Measured by Medical Outcomes Study (MOS)
Index=1 Week 24
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Weeks 12 and 24Population: Intent to Treat Population
The PHQ-8 is an 8-item questionnaire that aims at assessing the level of mood of a subject. Each item is scored from 0 = "not at all" to 3= "nearly every day"; the total score, which is the sum of the score for each item, can be from 0 to 24. A score ≥10 is considered major depression and ≥20 is severe major depression.
Outcome measures
| Measure |
Structured Discontinuation Opioid Therapy Suboptimal Responder
n=13 Participants
Structured discontinuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER), Suboptimal Responder
|
Continuation of Opioid Therapy Suboptimal Responder
n=12 Participants
Structured continuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER), Suboptimal Responder
|
Structured Discontinuation Opioid Therapy Optimal Responder
n=3 Participants
Structured discontinuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER), Optimal Responder
|
Continuation of Opioid Therapy Optimal Responder
n=4 Participants
Structured continuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER), Optimal Responder
|
|---|---|---|---|---|
|
Change From Baseline in the Patient Health Questionnaire Depression Scale (PHQ-8)
12 Weeks
|
-1.2 Score on a scale
Standard Deviation 4.75
|
-0.8 Score on a scale
Standard Deviation 4.94
|
3.3 Score on a scale
Standard Deviation 6.81
|
3.3 Score on a scale
Standard Deviation 6.50
|
|
Change From Baseline in the Patient Health Questionnaire Depression Scale (PHQ-8)
24 Weeks
|
0.7 Score on a scale
Standard Deviation 3.47
|
-1.1 Score on a scale
Standard Deviation 3.98
|
0.00 Score on a scale
Standard Deviation 7.07
|
-1.3 Score on a scale
Standard Deviation 0.58
|
SECONDARY outcome
Timeframe: Baseline, 12 and 24 week visitPopulation: Intent to Treat Population
The PHQ-8 is an 8-item questionnaire that aims at assessing the level of depression of a subject. Each item is scored from 0 = "not at all" to 3= "nearly every day"; the total score, which is the sum of the scores for each item, can be from 0 to 24. A score \>= 10 is considered major depression and \>= 20 is severe major depression.
Outcome measures
| Measure |
Structured Discontinuation Opioid Therapy Suboptimal Responder
n=13 Participants
Structured discontinuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER), Suboptimal Responder
|
Continuation of Opioid Therapy Suboptimal Responder
n=12 Participants
Structured continuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER), Suboptimal Responder
|
Structured Discontinuation Opioid Therapy Optimal Responder
n=3 Participants
Structured discontinuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER), Optimal Responder
|
Continuation of Opioid Therapy Optimal Responder
n=4 Participants
Structured continuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER), Optimal Responder
|
|---|---|---|---|---|
|
Number of Participants Reporting Major or Severe Major Depression Using Patient Health Questionnaire Depression Scale (PHQ-8)
Severe Major Depression Week 12
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Major or Severe Major Depression Using Patient Health Questionnaire Depression Scale (PHQ-8)
Major Depression Baseline
|
2 Participants
|
5 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Major or Severe Major Depression Using Patient Health Questionnaire Depression Scale (PHQ-8)
Severe Major Depression Baseline
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Major or Severe Major Depression Using Patient Health Questionnaire Depression Scale (PHQ-8)
Major Depression Week 12
|
1 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants Reporting Major or Severe Major Depression Using Patient Health Questionnaire Depression Scale (PHQ-8)
Major Depression Week 24
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Major or Severe Major Depression Using Patient Health Questionnaire Depression Scale (PHQ-8)
Severe Major Depression Week 24
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline and weeks 12, 24Population: Intent to Treat Population
The EQ-5D-5L is a self-administered general measure of health outcome applicable to a wide range of health conditions and treatments.The EQ-5D-5L measures quality of life in 5 dimensions: Mobility, Self-care, Usual activities, Pain/discomfort, and Anxiety/depression. Each is rated in 5 levels from no problems/pain/anxiety to being unable/extreme pain/extreme anxiety. The responses for each category are summarized by treatment and visit with frequencies and percentages reporting each level.
Outcome measures
| Measure |
Structured Discontinuation Opioid Therapy Suboptimal Responder
n=13 Participants
Structured discontinuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER), Suboptimal Responder
|
Continuation of Opioid Therapy Suboptimal Responder
n=12 Participants
Structured continuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER), Suboptimal Responder
|
Structured Discontinuation Opioid Therapy Optimal Responder
n=3 Participants
Structured discontinuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER), Optimal Responder
|
Continuation of Opioid Therapy Optimal Responder
n=4 Participants
Structured continuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER), Optimal Responder
|
|---|---|---|---|---|
|
Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument
No problem Walking Week 12
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument
No problem Walking Baseline
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument
Slight Problem Walking Baseline
|
1 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument
Moderate Problem Walking Baseline
|
8 Participants
|
7 Participants
|
0 Participants
|
1 Participants
|
|
Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument
Severe Problem Walking Baseline
|
3 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument
Unable to Walk Baseline
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument
No problem washing or dressing Baseline
|
1 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
|
Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument
Slight problem washing or dressing baseline
|
1 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
|
Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument
Moderate problem washing or dressing baseline
|
10 Participants
|
5 Participants
|
0 Participants
|
0 Participants
|
|
Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument
Severe problem washing or dressing baseline
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument
Unable to wash or dress baseline
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument
No problem doing usual activities Baseline
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument
Slight problem doing usual activities Baseline
|
0 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument
Moderate problem doing usual activities baseline
|
10 Participants
|
5 Participants
|
1 Participants
|
1 Participants
|
|
Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument
Severe problem doing usual activities baseline
|
3 Participants
|
6 Participants
|
0 Participants
|
0 Participants
|
|
Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument
Unable to do usual activities baseline
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument
No pain or discomfort baseline
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument
Slight pain or discomfort baseline
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument
Moderate pain or discomfort baseline
|
6 Participants
|
6 Participants
|
2 Participants
|
2 Participants
|
|
Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument
Severe pain or discomfort baseline
|
7 Participants
|
6 Participants
|
0 Participants
|
0 Participants
|
|
Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument
Extreme pain or discomfort baseline
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument
Not anxious or depressed baseline
|
4 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
|
Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument
Slightly anxious or depressed baseline
|
5 Participants
|
4 Participants
|
2 Participants
|
2 Participants
|
|
Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument
Moderately anxious or depressed baseline
|
4 Participants
|
5 Participants
|
0 Participants
|
0 Participants
|
|
Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument
Severely anxious or depressed baseline
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument
Slight Problem Walking Week 12
|
2 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
|
Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument
Extremely anxious or depressed baseline
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument
Moderate Problem Walking Week 12
|
8 Participants
|
7 Participants
|
2 Participants
|
1 Participants
|
|
Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument
Severe Problem Walking Week 12
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument
Unable to Walk Week 12
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument
No problem washing or dressing Week 12
|
2 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
|
Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument
Slight problem washing or dressing Week 12
|
4 Participants
|
6 Participants
|
0 Participants
|
0 Participants
|
|
Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument
Moderate problem washing or dressing week 12
|
5 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
|
Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument
Severe problem washing or dressing Week 12
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument
Unable to wash or dress Week 12
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument
No problem doing usual activities Week 12
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument
Slight problem doing usual activities Week 12
|
4 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
|
Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument
Moderate problem doing usual activities Week 12
|
4 Participants
|
6 Participants
|
1 Participants
|
2 Participants
|
|
Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument
Severe problem doing usual activities Week 12
|
4 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument
Unable to do usual activities Week 12
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument
No pain or discomfort Week 12
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument
Slight pain or discomfort Week 12
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument
Moderate pain or discomfort Week 12
|
11 Participants
|
9 Participants
|
2 Participants
|
2 Participants
|
|
Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument
Severe pain or discomfort Week 12
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument
Extreme pain or discomfort Week 12
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument
Not anxious or depressed Week 12
|
7 Participants
|
7 Participants
|
1 Participants
|
3 Participants
|
|
Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument
Slightly anxious or depressed Week 12
|
2 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
|
Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument
Moderately anxious or depressed Week 12
|
4 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument
Severely anxious or depressed Week 12
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument
Extremely anxious or depressed Week 12
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument
No problem Walking Week 24
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument
Slight Problem Walking Week 24
|
2 Participants
|
4 Participants
|
1 Participants
|
2 Participants
|
|
Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument
Moderate Problem Walking Week 24
|
5 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument
Severe Problem Walking Week 24
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument
Unable to Walk Week 24
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument
No problem washing or dressing Week 24
|
3 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
|
Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument
Slight problem washing or dressing Week 24
|
3 Participants
|
4 Participants
|
0 Participants
|
1 Participants
|
|
Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument
Moderate problem washing or dressing Week 24
|
3 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument
Severe problem washing or dressing Week 24
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument
Unable to washing or dressing Week 24
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument
No problem doing usual activities Week 24
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument
Slight problem doing usual activities Week 24
|
2 Participants
|
5 Participants
|
0 Participants
|
1 Participants
|
|
Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument
Moderate problem doing usual activities Week 24
|
4 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument
Severe problem doing usual activities Week 24
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument
Unable to do usual activities Week 24
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument
No pain or discomfort Week 24
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument
Slight pain or discomfort Week 24
|
1 Participants
|
4 Participants
|
1 Participants
|
1 Participants
|
|
Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument
Moderate pain or discomfort Week 24
|
5 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument
Severe pain or discomfort Week 24
|
4 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument
Extreme pain or discomfort Week 24
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument
Not anxious or depressed Week 24
|
4 Participants
|
5 Participants
|
1 Participants
|
2 Participants
|
|
Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument
Slightly anxious or depressed Week 24
|
3 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument
Moderately anxious or depressed Week 24
|
3 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument
Severely anxious or depressed Week 24
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument
Extremely anxious or depressed Week 24
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline to 12 and 24 week visitPopulation: Intent to Treat Population
The EQ-5D-5L is a self-administered general measure of health outcome applicable to a wide range of health conditions and treatments. The visual analog scale (VAS) rates the subject's health on a 0-100 scale from the worst imaginable health state to the best imaginable health state.
Outcome measures
| Measure |
Structured Discontinuation Opioid Therapy Suboptimal Responder
n=13 Participants
Structured discontinuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER), Suboptimal Responder
|
Continuation of Opioid Therapy Suboptimal Responder
n=12 Participants
Structured continuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER), Suboptimal Responder
|
Structured Discontinuation Opioid Therapy Optimal Responder
n=3 Participants
Structured discontinuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER), Optimal Responder
|
Continuation of Opioid Therapy Optimal Responder
n=4 Participants
Structured continuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER), Optimal Responder
|
|---|---|---|---|---|
|
Participant Reported Quality of Life Assessment Using Visual Analog Scale (EQ-5D-5L Standardized Instrument)
Week 12 visit
|
5.5 Score on a scale
Standard Deviation 11.45
|
3.2 Score on a scale
Standard Deviation 25.89
|
-17.7 Score on a scale
Standard Deviation 12.01
|
-6.3 Score on a scale
Standard Deviation 7.97
|
|
Participant Reported Quality of Life Assessment Using Visual Analog Scale (EQ-5D-5L Standardized Instrument)
Week 24 visit
|
4.5 Score on a scale
Standard Deviation 18.68
|
8.4 Score on a scale
Standard Deviation 28.57
|
-4.5 Score on a scale
Standard Deviation 13.44
|
0.3 Score on a scale
Standard Deviation 5.86
|
SECONDARY outcome
Timeframe: Change from Baseline to 12 and 24 week visitPopulation: Intent to Treat Population
Overall neuropsychological function is assessed using the DSST, a test that is sensitive to brain damage, dementia, age, and depression, and is a widely used instrument for measuring the neuropsychological effects of opioid therapy. The digits (1-9) are paired with symbols, and the test consists of matching the symbol for a series of digits as fast as possible. Score is number of correct symbols in 90 seconds. A decrease from baseline detects deterioration in processing speed. An increase from baseline detects improvement in processing speed.
Outcome measures
| Measure |
Structured Discontinuation Opioid Therapy Suboptimal Responder
n=13 Participants
Structured discontinuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER), Suboptimal Responder
|
Continuation of Opioid Therapy Suboptimal Responder
n=12 Participants
Structured continuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER), Suboptimal Responder
|
Structured Discontinuation Opioid Therapy Optimal Responder
n=3 Participants
Structured discontinuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER), Optimal Responder
|
Continuation of Opioid Therapy Optimal Responder
n=4 Participants
Structured continuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER), Optimal Responder
|
|---|---|---|---|---|
|
Digit Symbol Substitution Test
Week 12 from baseline
|
7.8 Score on a test
Standard Deviation 8.23
|
6.1 Score on a test
Standard Deviation 10.22
|
3.3 Score on a test
Standard Deviation 7.64
|
0.00 Score on a test
Standard Deviation 4.83
|
|
Digit Symbol Substitution Test
Week 24 from baseline
|
8.9 Score on a test
Standard Deviation 8.41
|
0.1 Score on a test
Standard Deviation 12.84
|
-6.0 Score on a test
Standard Deviation 5.66
|
-3.3 Score on a test
Standard Deviation 7.64
|
SECONDARY outcome
Timeframe: Baseline to 12 and 24 week visitPopulation: Intent to Treat Population
The Patient Global Impression of Change (PGIC) is a self-administered questionnaire that assesses the participant's level of improvement/worsening from the beginning to the end of treatment. Participants are asked to select the category of change that most closely describes any change experienced in the pain of their painful areas from the beginning of the Blinded Structured Opioid Discontinuation Period to Week 12 and to Week 24. The scale has levels describing change as: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse.
Outcome measures
| Measure |
Structured Discontinuation Opioid Therapy Suboptimal Responder
n=13 Participants
Structured discontinuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER), Suboptimal Responder
|
Continuation of Opioid Therapy Suboptimal Responder
n=12 Participants
Structured continuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER), Suboptimal Responder
|
Structured Discontinuation Opioid Therapy Optimal Responder
n=3 Participants
Structured discontinuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER), Optimal Responder
|
Continuation of Opioid Therapy Optimal Responder
n=4 Participants
Structured continuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER), Optimal Responder
|
|---|---|---|---|---|
|
Patient Global Impression of Change (PGIC)
Very much improved Week 12
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Patient Global Impression of Change (PGIC)
Much improved Week 12
|
3 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Patient Global Impression of Change (PGIC)
Minimally improved Week 12
|
8 Participants
|
5 Participants
|
1 Participants
|
1 Participants
|
|
Patient Global Impression of Change (PGIC)
No change Week 12
|
1 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Patient Global Impression of Change (PGIC)
Minimally Worse Week 12
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Patient Global Impression of Change (PGIC)
Much Worse Week 12
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Patient Global Impression of Change (PGIC)
Very Much Worse Week 12
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Patient Global Impression of Change (PGIC)
Very much improved Week 24
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Patient Global Impression of Change (PGIC)
Much improved Week 24
|
3 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Patient Global Impression of Change (PGIC)
Minimally improved Week 24
|
3 Participants
|
4 Participants
|
2 Participants
|
0 Participants
|
|
Patient Global Impression of Change (PGIC)
No change Week 24
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Patient Global Impression of Change (PGIC)
Minimally Worse Week 24
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Patient Global Impression of Change (PGIC)
Much Worse Week 24
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Patient Global Impression of Change (PGIC)
Very Much Worse Week 24
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Change from Baseline to 12 and 24 week visitPopulation: Intent to Treat Population
For the International Index of Erectile Function (IIEF)(15-items) each question is scored on a scale of 0 or 1 to 5, with 0 as no sexual attempts, 1 as the highest frequency, and 5 as the lowest, except where 1=1-2, 2=3-4, 3=5-6, 4=7-10 attempts, and 5=11 or more attempts. Missing responses are scored as 0. For the Female Sexual Function Index (FSFI)(19 items) each question is scored on a scale of 0-5 or 1-5. The FSFI examines the following 6 domains with minimum and maximum scores as indicated: desire(1.2-6.0), arousal(0-6.0), lubrication(0-6.0), orgasm(0-6.0), satisfaction(0.8-6.0), and pain(0-6.0). A computational formula sums the scores within each domain and multiplies that sum by a prescribed weighting factor: desire 0.6, arousal 0.3, lubrication 0.3, orgasm 0.4, satisfaction 0.4, pain 0.4. Higher scores indicate greater functionality. The single final score range is 2.0 to 36, which is reported as an average for each group of female study participants as change from baseline.
Outcome measures
| Measure |
Structured Discontinuation Opioid Therapy Suboptimal Responder
n=13 Participants
Structured discontinuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER), Suboptimal Responder
|
Continuation of Opioid Therapy Suboptimal Responder
n=12 Participants
Structured continuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER), Suboptimal Responder
|
Structured Discontinuation Opioid Therapy Optimal Responder
n=3 Participants
Structured discontinuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER), Optimal Responder
|
Continuation of Opioid Therapy Optimal Responder
n=4 Participants
Structured continuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER), Optimal Responder
|
|---|---|---|---|---|
|
Sexual Function Measured Using the International Index of Erectile Function (IIEF) for Men and the Female Sexual Function Index (FSFI) for Women
Female Satisfaction Week 12
|
-0.10 Score on a scale
Standard Deviation 0.849
|
-0.40 Score on a scale
Standard Deviation 3.046
|
-0.40 Score on a scale
Standard Deviation 0
|
0.0 Score on a scale
Standard Deviation 0.00
|
|
Sexual Function Measured Using the International Index of Erectile Function (IIEF) for Men and the Female Sexual Function Index (FSFI) for Women
Female Satisfaction Week 24
|
-0.72 Score on a scale
Standard Deviation 1.277
|
-0.67 Score on a scale
Standard Deviation 1.155
|
—
|
0.00 Score on a scale
Standard Deviation 0
|
|
Sexual Function Measured Using the International Index of Erectile Function (IIEF) for Men and the Female Sexual Function Index (FSFI) for Women
Female Pain Week 12
|
0.65 Score on a scale
Standard Deviation 3.312
|
2.69 Score on a scale
Standard Deviation 2.589
|
-3.20 Score on a scale
Standard Deviation 0
|
-0.40 Score on a scale
Standard Deviation 1.131
|
|
Sexual Function Measured Using the International Index of Erectile Function (IIEF) for Men and the Female Sexual Function Index (FSFI) for Women
Female Pain Week 24
|
0.88 Score on a scale
Standard Deviation 3.411
|
0.80 Score on a scale
Standard Deviation 1.386
|
—
|
0.40 Score on a scale
Standard Deviation 0
|
|
Sexual Function Measured Using the International Index of Erectile Function (IIEF) for Men and the Female Sexual Function Index (FSFI) for Women
Female Arousal Week 24
|
1.80 Score on a scale
Standard Deviation 0.561
|
-0.90 Score on a scale
Standard Deviation 1.559
|
—
|
0.90 Score on a scale
Standard Deviation 0
|
|
Sexual Function Measured Using the International Index of Erectile Function (IIEF) for Men and the Female Sexual Function Index (FSFI) for Women
Female Lubrication Week 12
|
0.00 Score on a scale
Standard Deviation 2.368
|
0.94 Score on a scale
Standard Deviation 1.514
|
-3.60 Score on a scale
Standard Deviation 0
|
0.30 Score on a scale
Standard Deviation 0.000
|
|
Sexual Function Measured Using the International Index of Erectile Function (IIEF) for Men and the Female Sexual Function Index (FSFI) for Women
Female Lubrication Week 24
|
0.30 Score on a scale
Standard Deviation 2.205
|
0.30 Score on a scale
Standard Deviation 0.520
|
—
|
0 Score on a scale
Standard Deviation 0
|
|
Sexual Function Measured Using the International Index of Erectile Function (IIEF) for Men and the Female Sexual Function Index (FSFI) for Women
Female Orgasm Week 12
|
-0.05 Score on a scale
Standard Deviation 2.216
|
0.91 Score on a scale
Standard Deviation 2.650
|
-4.40 Score on a scale
Standard Deviation 0
|
0.20 Score on a scale
Standard Deviation 0.283
|
|
Sexual Function Measured Using the International Index of Erectile Function (IIEF) for Men and the Female Sexual Function Index (FSFI) for Women
Male Erectile Function Week 12
|
2.0 Score on a scale
Standard Deviation 7.14
|
-4.6 Score on a scale
Standard Deviation 10.26
|
4.0 Score on a scale
Standard Deviation 2.83
|
2.00 Score on a scale
Standard Deviation 7.07
|
|
Sexual Function Measured Using the International Index of Erectile Function (IIEF) for Men and the Female Sexual Function Index (FSFI) for Women
Male Erectile Function Week 24
|
1.4 Score on a scale
Standard Deviation 13.56
|
-0.4 Score on a scale
Standard Deviation 11.26
|
7.0 Score on a scale
Standard Deviation 9.90
|
4.5 Score on a scale
Standard Deviation 0.71
|
|
Sexual Function Measured Using the International Index of Erectile Function (IIEF) for Men and the Female Sexual Function Index (FSFI) for Women
Male Orgasmic Function Week 12
|
-1.0 Score on a scale
Standard Deviation 5.20
|
-1.0 Score on a scale
Standard Deviation 4.24
|
0.5 Score on a scale
Standard Deviation 0.71
|
1.5 Score on a scale
Standard Deviation 0.71
|
|
Sexual Function Measured Using the International Index of Erectile Function (IIEF) for Men and the Female Sexual Function Index (FSFI) for Women
Male Orgasmic Function Week 24
|
-0.6 Score on a scale
Standard Deviation 7.33
|
0.4 Score on a scale
Standard Deviation 4.83
|
1.5 Score on a scale
Standard Deviation 0.71
|
2.0 Score on a scale
Standard Deviation 0.00
|
|
Sexual Function Measured Using the International Index of Erectile Function (IIEF) for Men and the Female Sexual Function Index (FSFI) for Women
Male Sexual Desire Week 12
|
2.2 Score on a scale
Standard Deviation 1.30
|
1.0 Score on a scale
Standard Deviation 2.35
|
0.0 Score on a scale
Standard Deviation 0.00
|
0.0 Score on a scale
Standard Deviation 0.00
|
|
Sexual Function Measured Using the International Index of Erectile Function (IIEF) for Men and the Female Sexual Function Index (FSFI) for Women
Male Sexual Desire Week 24
|
1.8 Score on a scale
Standard Deviation 2.59
|
0.8 Score on a scale
Standard Deviation 1.64
|
-1.5 Score on a scale
Standard Deviation 3.54
|
0.0 Score on a scale
Standard Deviation 1.41
|
|
Sexual Function Measured Using the International Index of Erectile Function (IIEF) for Men and the Female Sexual Function Index (FSFI) for Women
Male Intercourse Satisfaction Week 12
|
-1.0 Score on a scale
Standard Deviation 5.20
|
-1.4 Score on a scale
Standard Deviation 5.22
|
0.5 Score on a scale
Standard Deviation 0.71
|
0.0 Score on a scale
Standard Deviation 0.00
|
|
Sexual Function Measured Using the International Index of Erectile Function (IIEF) for Men and the Female Sexual Function Index (FSFI) for Women
Male Intercourse Satisfaction Week 24
|
-1.0 Score on a scale
Standard Deviation 7.68
|
0.4 Score on a scale
Standard Deviation 5.41
|
2.0 Score on a scale
Standard Deviation 2.83
|
1.5 Score on a scale
Standard Deviation 0.71
|
|
Sexual Function Measured Using the International Index of Erectile Function (IIEF) for Men and the Female Sexual Function Index (FSFI) for Women
Male Overall Satisfaction Week 12
|
1.8 Score on a scale
Standard Deviation 1.79
|
1.4 Score on a scale
Standard Deviation 3.36
|
1.5 Score on a scale
Standard Deviation 2.12
|
0.5 Score on a scale
Standard Deviation 2.12
|
|
Sexual Function Measured Using the International Index of Erectile Function (IIEF) for Men and the Female Sexual Function Index (FSFI) for Women
Male Overall Satisfaction Week 24
|
3.4 Score on a scale
Standard Deviation 1.67
|
2.2 Score on a scale
Standard Deviation 2.05
|
0.0 Score on a scale
Standard Deviation 2.83
|
0.0 Score on a scale
Standard Deviation 1.41
|
|
Sexual Function Measured Using the International Index of Erectile Function (IIEF) for Men and the Female Sexual Function Index (FSFI) for Women
Female Desire Week 12
|
0.23 Score on a scale
Standard Deviation 1.280
|
-0.86 Score on a scale
Standard Deviation 1.544
|
0.00 Score on a scale
Standard Deviation 0
|
0.30 Score on a scale
Standard Deviation 0.424
|
|
Sexual Function Measured Using the International Index of Erectile Function (IIEF) for Men and the Female Sexual Function Index (FSFI) for Women
Female Desire Week 24
|
0.48 Score on a scale
Standard Deviation 1.301
|
-1.40 Score on a scale
Standard Deviation 1.510
|
—
|
0.00 Score on a scale
Standard Deviation 0
|
|
Sexual Function Measured Using the International Index of Erectile Function (IIEF) for Men and the Female Sexual Function Index (FSFI) for Women
Female Arousal Week 12
|
0.38 Score on a scale
Standard Deviation 2.711
|
-0.47 Score on a scale
Standard Deviation 1.614
|
-6.00 Score on a scale
Standard Deviation 0
|
1.35 Score on a scale
Standard Deviation 0.636
|
|
Sexual Function Measured Using the International Index of Erectile Function (IIEF) for Men and the Female Sexual Function Index (FSFI) for Women
Female Orgasm Week 24
|
0.40 Score on a scale
Standard Deviation 3.007
|
0.27 Score on a scale
Standard Deviation 0.462
|
—
|
-0.40 Score on a scale
Standard Deviation 0
|
Adverse Events
Structured Discontinuation Opioid Therapy Suboptimal Responder
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Continuation of Opioid Therapy Suboptimal Responder
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Structured Discontinuation Opioid Therapy Optimal Responder
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Continuation of Opioid Therapy Optimal Responder
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Structured Discontinuation Opioid Therapy Suboptimal Responder
n=13 participants at risk
Structured discontinuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER), Suboptimal Responder
|
Continuation of Opioid Therapy Suboptimal Responder
n=12 participants at risk
Structured continuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER), Suboptimal Responder
|
Structured Discontinuation Opioid Therapy Optimal Responder
n=3 participants at risk
Structured discontinuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER), Optimal Respond
|
Continuation of Opioid Therapy Optimal Responder
n=4 participants at risk
Structured continuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER), Optimal Responder
|
|---|---|---|---|---|
|
Renal and urinary disorders
Urinary Tract Infection
|
7.7%
1/13 • Up to 34 Weeks Post Randomization
|
0.00%
0/12 • Up to 34 Weeks Post Randomization
|
0.00%
0/3 • Up to 34 Weeks Post Randomization
|
0.00%
0/4 • Up to 34 Weeks Post Randomization
|
Other adverse events
| Measure |
Structured Discontinuation Opioid Therapy Suboptimal Responder
n=13 participants at risk
Structured discontinuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER), Suboptimal Responder
|
Continuation of Opioid Therapy Suboptimal Responder
n=12 participants at risk
Structured continuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER), Suboptimal Responder
|
Structured Discontinuation Opioid Therapy Optimal Responder
n=3 participants at risk
Structured discontinuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER), Optimal Respond
|
Continuation of Opioid Therapy Optimal Responder
n=4 participants at risk
Structured continuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER), Optimal Responder
|
|---|---|---|---|---|
|
Investigations
Drug Screen Positive
|
15.4%
2/13 • Up to 34 Weeks Post Randomization
|
8.3%
1/12 • Up to 34 Weeks Post Randomization
|
0.00%
0/3 • Up to 34 Weeks Post Randomization
|
0.00%
0/4 • Up to 34 Weeks Post Randomization
|
|
Investigations
Urine Alcohol Test Positive
|
7.7%
1/13 • Up to 34 Weeks Post Randomization
|
8.3%
1/12 • Up to 34 Weeks Post Randomization
|
0.00%
0/3 • Up to 34 Weeks Post Randomization
|
0.00%
0/4 • Up to 34 Weeks Post Randomization
|
|
Investigations
Liver Function Test Abnormal
|
7.7%
1/13 • Up to 34 Weeks Post Randomization
|
0.00%
0/12 • Up to 34 Weeks Post Randomization
|
0.00%
0/3 • Up to 34 Weeks Post Randomization
|
0.00%
0/4 • Up to 34 Weeks Post Randomization
|
|
Gastrointestinal disorders
Nausea
|
7.7%
1/13 • Up to 34 Weeks Post Randomization
|
8.3%
1/12 • Up to 34 Weeks Post Randomization
|
0.00%
0/3 • Up to 34 Weeks Post Randomization
|
0.00%
0/4 • Up to 34 Weeks Post Randomization
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/13 • Up to 34 Weeks Post Randomization
|
8.3%
1/12 • Up to 34 Weeks Post Randomization
|
0.00%
0/3 • Up to 34 Weeks Post Randomization
|
0.00%
0/4 • Up to 34 Weeks Post Randomization
|
|
Gastrointestinal disorders
Irritable Bowel Syndrome
|
7.7%
1/13 • Up to 34 Weeks Post Randomization
|
0.00%
0/12 • Up to 34 Weeks Post Randomization
|
0.00%
0/3 • Up to 34 Weeks Post Randomization
|
0.00%
0/4 • Up to 34 Weeks Post Randomization
|
|
Infections and infestations
Perineal Abscess
|
7.7%
1/13 • Up to 34 Weeks Post Randomization
|
0.00%
0/12 • Up to 34 Weeks Post Randomization
|
0.00%
0/3 • Up to 34 Weeks Post Randomization
|
0.00%
0/4 • Up to 34 Weeks Post Randomization
|
|
Infections and infestations
Pharyngitis streptococcal
|
7.7%
1/13 • Up to 34 Weeks Post Randomization
|
0.00%
0/12 • Up to 34 Weeks Post Randomization
|
0.00%
0/3 • Up to 34 Weeks Post Randomization
|
0.00%
0/4 • Up to 34 Weeks Post Randomization
|
|
Infections and infestations
Tooth infection
|
7.7%
1/13 • Up to 34 Weeks Post Randomization
|
0.00%
0/12 • Up to 34 Weeks Post Randomization
|
0.00%
0/3 • Up to 34 Weeks Post Randomization
|
0.00%
0/4 • Up to 34 Weeks Post Randomization
|
|
Infections and infestations
Urinary Tract Infection
|
7.7%
1/13 • Up to 34 Weeks Post Randomization
|
0.00%
0/12 • Up to 34 Weeks Post Randomization
|
0.00%
0/3 • Up to 34 Weeks Post Randomization
|
0.00%
0/4 • Up to 34 Weeks Post Randomization
|
|
Psychiatric disorders
Anxiety
|
15.4%
2/13 • Up to 34 Weeks Post Randomization
|
8.3%
1/12 • Up to 34 Weeks Post Randomization
|
0.00%
0/3 • Up to 34 Weeks Post Randomization
|
0.00%
0/4 • Up to 34 Weeks Post Randomization
|
|
Psychiatric disorders
Insomnia
|
7.7%
1/13 • Up to 34 Weeks Post Randomization
|
8.3%
1/12 • Up to 34 Weeks Post Randomization
|
0.00%
0/3 • Up to 34 Weeks Post Randomization
|
0.00%
0/4 • Up to 34 Weeks Post Randomization
|
|
General disorders
Drug withdrawal syndrome
|
0.00%
0/13 • Up to 34 Weeks Post Randomization
|
25.0%
3/12 • Up to 34 Weeks Post Randomization
|
0.00%
0/3 • Up to 34 Weeks Post Randomization
|
0.00%
0/4 • Up to 34 Weeks Post Randomization
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/13 • Up to 34 Weeks Post Randomization
|
8.3%
1/12 • Up to 34 Weeks Post Randomization
|
0.00%
0/3 • Up to 34 Weeks Post Randomization
|
25.0%
1/4 • Up to 34 Weeks Post Randomization
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.7%
1/13 • Up to 34 Weeks Post Randomization
|
0.00%
0/12 • Up to 34 Weeks Post Randomization
|
0.00%
0/3 • Up to 34 Weeks Post Randomization
|
0.00%
0/4 • Up to 34 Weeks Post Randomization
|
|
Ear and labyrinth disorders
Haematotympanum
|
0.00%
0/13 • Up to 34 Weeks Post Randomization
|
8.3%
1/12 • Up to 34 Weeks Post Randomization
|
0.00%
0/3 • Up to 34 Weeks Post Randomization
|
0.00%
0/4 • Up to 34 Weeks Post Randomization
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
7.7%
1/13 • Up to 34 Weeks Post Randomization
|
0.00%
0/12 • Up to 34 Weeks Post Randomization
|
0.00%
0/3 • Up to 34 Weeks Post Randomization
|
0.00%
0/4 • Up to 34 Weeks Post Randomization
|
|
Nervous system disorders
Tremor
|
7.7%
1/13 • Up to 34 Weeks Post Randomization
|
0.00%
0/12 • Up to 34 Weeks Post Randomization
|
0.00%
0/3 • Up to 34 Weeks Post Randomization
|
0.00%
0/4 • Up to 34 Weeks Post Randomization
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
7.7%
1/13 • Up to 34 Weeks Post Randomization
|
0.00%
0/12 • Up to 34 Weeks Post Randomization
|
0.00%
0/3 • Up to 34 Weeks Post Randomization
|
0.00%
0/4 • Up to 34 Weeks Post Randomization
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.7%
1/13 • Up to 34 Weeks Post Randomization
|
0.00%
0/12 • Up to 34 Weeks Post Randomization
|
0.00%
0/3 • Up to 34 Weeks Post Randomization
|
0.00%
0/4 • Up to 34 Weeks Post Randomization
|
|
Nervous system disorders
Headache
|
0.00%
0/13 • Up to 34 Weeks Post Randomization
|
0.00%
0/12 • Up to 34 Weeks Post Randomization
|
33.3%
1/3 • Up to 34 Weeks Post Randomization
|
0.00%
0/4 • Up to 34 Weeks Post Randomization
|
|
Nervous system disorders
Sciatica
|
0.00%
0/13 • Up to 34 Weeks Post Randomization
|
0.00%
0/12 • Up to 34 Weeks Post Randomization
|
0.00%
0/3 • Up to 34 Weeks Post Randomization
|
25.0%
1/4 • Up to 34 Weeks Post Randomization
|
|
General disorders
Ear Pain
|
0.00%
0/13 • Up to 34 Weeks Post Randomization
|
0.00%
0/12 • Up to 34 Weeks Post Randomization
|
0.00%
0/3 • Up to 34 Weeks Post Randomization
|
25.0%
1/4 • Up to 34 Weeks Post Randomization
|
|
Eye disorders
Vision blurred
|
0.00%
0/13 • Up to 34 Weeks Post Randomization
|
0.00%
0/12 • Up to 34 Weeks Post Randomization
|
33.3%
1/3 • Up to 34 Weeks Post Randomization
|
0.00%
0/4 • Up to 34 Weeks Post Randomization
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/13 • Up to 34 Weeks Post Randomization
|
0.00%
0/12 • Up to 34 Weeks Post Randomization
|
33.3%
1/3 • Up to 34 Weeks Post Randomization
|
0.00%
0/4 • Up to 34 Weeks Post Randomization
|
|
General disorders
Pain
|
0.00%
0/13 • Up to 34 Weeks Post Randomization
|
0.00%
0/12 • Up to 34 Weeks Post Randomization
|
33.3%
1/3 • Up to 34 Weeks Post Randomization
|
0.00%
0/4 • Up to 34 Weeks Post Randomization
|
|
Infections and infestations
Sinusitis
|
0.00%
0/13 • Up to 34 Weeks Post Randomization
|
0.00%
0/12 • Up to 34 Weeks Post Randomization
|
0.00%
0/3 • Up to 34 Weeks Post Randomization
|
25.0%
1/4 • Up to 34 Weeks Post Randomization
|
|
Injury, poisoning and procedural complications
Drug dispensing error
|
0.00%
0/13 • Up to 34 Weeks Post Randomization
|
0.00%
0/12 • Up to 34 Weeks Post Randomization
|
33.3%
1/3 • Up to 34 Weeks Post Randomization
|
0.00%
0/4 • Up to 34 Weeks Post Randomization
|
Additional Information
John Han, Associate Director, Statistics
Janssen Pharmaceuticals, Inc.
Phone: 484-354-3547
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place