Trial Outcomes & Findings for Safety and Efficacy Study of Hydromorphone Hydrochloride by Intrathecal Administration (NCT NCT01709721)
NCT ID: NCT01709721
Last Updated: 2021-11-04
Results Overview
Treatment failure during the Randomized Phase is defined as at least one of the following: a) increase of \>= 20mm VASPI vs. baseline over 5 days; b) intolerable pain that in investigator's opinion requires intervention; or c) pain-related interventions that violate protocol from Day 84 to Day 119. Note: Baseline pain for the randomized phase is defined as the average of the last 5 days with daily pain measurements while on an optimal intrathecal dose of Hydromorphone, between Days 77 and 83 of the open label dosing period. Note: A subject who does not have sufficient data for evaluation, drops out for any other reasons that are not listed above or who experiences withdrawal syndrome as identified by COWS \> 12 during the randomized phase will not be classified as a treatment failure. Note: Analysis period is from beginning of randomization phase (Day 84) to end of study.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
153 participants
Primary outcome timeframe
5 weeks [Baseline (Day 84) to Day 119 Visit]
Results posted on
2021-11-04
Participant Flow
Participant milestones
| Measure |
Hydromorphone Hydrochloride (Randomized/Double-Blind)
Subjects stay on their current dose of Hydromorphone Hydrochloride administered via intrathecal (IT) pump; depending on the subject's starting dose on hydromorphone hydrochloride, either a 2 mg/mL or 10 mg/mL formulation may be used.
Hydromorphone Hydrochloride: Opioid for chronic pain
Device: Programmable Implantable pump delivering intrathecal hydromorphone hydrochloride
|
Hydromorphone Titrated Downward/Control (Randomized/Double-Blind)
Subjects have their current dose of Hydromorphone Hydrochloride dose titrated downward; administered via Intrathecal pump
Hydromorphone Hydrochloride: Opioid for chronic pain
Device: Programmable Implantable pump delivering intrathecal hydromorphone hydrochloride
|
Not Randomized (Open Label Only)
Enrolled but Not Randomized, dropped out during Open Label phase. Open Label treatment only of their current dose of Hydromorphone Hydrochloride administered via intrathecal (IT) pump; depending on the subject's starting dose on hydromorphone hydrochloride, either a 2 mg/mL or 10 mg/mL formulation may be used.
Hydromorphone Hydrochloride: Opioid for chronic pain
Device: Programmable Implantable pump delivering intrathecal hydromorphone hydrochloride
|
|---|---|---|---|
|
Open Label Phase
STARTED
|
41
|
40
|
72
|
|
Open Label Phase
COMPLETED
|
41
|
40
|
0
|
|
Open Label Phase
NOT COMPLETED
|
0
|
0
|
72
|
|
Randomized Phase
STARTED
|
41
|
40
|
0
|
|
Randomized Phase
COMPLETED
|
38
|
34
|
0
|
|
Randomized Phase
NOT COMPLETED
|
3
|
6
|
0
|
Reasons for withdrawal
| Measure |
Hydromorphone Hydrochloride (Randomized/Double-Blind)
Subjects stay on their current dose of Hydromorphone Hydrochloride administered via intrathecal (IT) pump; depending on the subject's starting dose on hydromorphone hydrochloride, either a 2 mg/mL or 10 mg/mL formulation may be used.
Hydromorphone Hydrochloride: Opioid for chronic pain
Device: Programmable Implantable pump delivering intrathecal hydromorphone hydrochloride
|
Hydromorphone Titrated Downward/Control (Randomized/Double-Blind)
Subjects have their current dose of Hydromorphone Hydrochloride dose titrated downward; administered via Intrathecal pump
Hydromorphone Hydrochloride: Opioid for chronic pain
Device: Programmable Implantable pump delivering intrathecal hydromorphone hydrochloride
|
Not Randomized (Open Label Only)
Enrolled but Not Randomized, dropped out during Open Label phase. Open Label treatment only of their current dose of Hydromorphone Hydrochloride administered via intrathecal (IT) pump; depending on the subject's starting dose on hydromorphone hydrochloride, either a 2 mg/mL or 10 mg/mL formulation may be used.
Hydromorphone Hydrochloride: Opioid for chronic pain
Device: Programmable Implantable pump delivering intrathecal hydromorphone hydrochloride
|
|---|---|---|---|
|
Open Label Phase
Withdrawal by Subject
|
0
|
0
|
5
|
|
Open Label Phase
Adverse Event
|
0
|
0
|
8
|
|
Open Label Phase
Non-compliance With Study Drug
|
0
|
0
|
3
|
|
Open Label Phase
Investigator Decision
|
0
|
0
|
1
|
|
Open Label Phase
Sponsor Decision
|
0
|
0
|
2
|
|
Open Label Phase
Protocol Violation
|
0
|
0
|
1
|
|
Open Label Phase
Changes In The Subject's Condition Render The Subject Unacceptable For Further Treatment
|
0
|
0
|
1
|
|
Open Label Phase
Inadequate Pain Control
|
0
|
0
|
37
|
|
Open Label Phase
Other, Specify in text field in database
|
0
|
0
|
14
|
|
Randomized Phase
Adverse Event
|
0
|
1
|
0
|
|
Randomized Phase
Lost to Follow-up
|
1
|
0
|
0
|
|
Randomized Phase
Inadequate Pain Control
|
1
|
2
|
0
|
|
Randomized Phase
Other, Specify text field in database
|
1
|
3
|
0
|
Baseline Characteristics
Safety and Efficacy Study of Hydromorphone Hydrochloride by Intrathecal Administration
Baseline characteristics by cohort
| Measure |
Hydromorphone Hydrochloride (Randomized/Double-Blind)
n=41 Participants
Subjects stay on their current dose of Hydromorphone Hydrochloride administered via intrathecal (IT) pump; depending on the subject's starting dose on hydromorphone hydrochloride, either a 2 mg/mL or 10 mg/mL formulation may be used.
Programmable Implantable pump: Programmable Implantable pump delivering intrathecal hydromorphone
|
Hydromorphone Titrated Downward/Control (Randomized/Double-Blind)
n=40 Participants
Subjects have their current dose of Hydromorphone Hydrochloride dose titrated downward; administered via Intrathecal pump
|
Not Randomized (Open Label Only)
n=72 Participants
Enrolled but Not Randomized, dropped out during Open Label phase. Open Label treatment only of their current dose of Hydromorphone Hydrochloride administered via intrathecal (IT) pump; depending on the subject's starting dose on hydromorphone hydrochloride, either a 2 mg/mL or 10 mg/mL formulation may be used.
Hydromorphone Hydrochloride: Opioid for chronic pain
Device: Programmable Implantable pump delivering intrathecal hydromorphone hydrochloride
|
Total
n=153 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
53.6 years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
54.8 years
STANDARD_DEVIATION 8.3 • n=7 Participants
|
57.1 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
55.6 years
STANDARD_DEVIATION 10 • n=4 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
92 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
61 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
40 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
147 Participants
n=4 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
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 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
|
|
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
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
38 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
144 Participants
n=4 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
|
|
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
|
|
Region of Enrollment
United States
|
41 participants
n=5 Participants
|
40 participants
n=7 Participants
|
72 participants
n=5 Participants
|
153 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 5 weeks [Baseline (Day 84) to Day 119 Visit]Population: Intent-to-Treat - Randomized Subjects. Subjects in the Open Label Phase of the study who discontinued the study prior to the Randomization Phase and/or did not meet the criteria for randomization are not included in this analysis as they were not randomized to a treatment group.
Treatment failure during the Randomized Phase is defined as at least one of the following: a) increase of \>= 20mm VASPI vs. baseline over 5 days; b) intolerable pain that in investigator's opinion requires intervention; or c) pain-related interventions that violate protocol from Day 84 to Day 119. Note: Baseline pain for the randomized phase is defined as the average of the last 5 days with daily pain measurements while on an optimal intrathecal dose of Hydromorphone, between Days 77 and 83 of the open label dosing period. Note: A subject who does not have sufficient data for evaluation, drops out for any other reasons that are not listed above or who experiences withdrawal syndrome as identified by COWS \> 12 during the randomized phase will not be classified as a treatment failure. Note: Analysis period is from beginning of randomization phase (Day 84) to end of study.
Outcome measures
| Measure |
Hydromorphone Hydrochloride (Randomized/Double-Blind)
n=41 Participants
Subjects on hydromorphone hydrochloride for the duration of therapy.
Hydromorphone Hydrochloride: Opioid for chronic pain
Programmable Implantable pump: Programmable Implantable pump delivering intrathecal hydromorphone
|
Hydromorphone Hydrochloride Titrated Downward/Control (Randomized/Double-Blind)
n=40 Participants
Hydromorphone Hydrochloride/Control Titrated Downward
Hydromorphone Hydrochloride: Opioid for chronic pain
Programmable Implantable pump: Programmable Implantable pump delivering intrathecal hydromorphone
|
|---|---|---|
|
Proportion of Subjects Who Are Treatment Failures During the Double-blind Randomized Withdrawal Period
|
18 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: 5 Weeks [Baseline (Day 84) to Day 119 Visit]Population: Intent-to-Treat - Randomized. Subjects in the Open Label Phase of the study who discontinued the study prior to the Randomization Phase and/or did not meet the criteria for randomization are not included in this analysis as they were not randomized to a treatment group.
'Worst' pain experienced in the past 24 hours. Brief Pain Inventory (BPI): Scale: 0 = No Pain, 10 = Pain as bad as you can imagine; a high score indicates a worse outcome.
Outcome measures
| Measure |
Hydromorphone Hydrochloride (Randomized/Double-Blind)
n=41 Participants
Subjects on hydromorphone hydrochloride for the duration of therapy.
Hydromorphone Hydrochloride: Opioid for chronic pain
Programmable Implantable pump: Programmable Implantable pump delivering intrathecal hydromorphone
|
Hydromorphone Hydrochloride Titrated Downward/Control (Randomized/Double-Blind)
n=40 Participants
Hydromorphone Hydrochloride/Control Titrated Downward
Hydromorphone Hydrochloride: Opioid for chronic pain
Programmable Implantable pump: Programmable Implantable pump delivering intrathecal hydromorphone
|
|---|---|---|
|
Brief Pain Inventory (BPI): Pain Severity, "Worst"
|
5.62 score on a scale
Standard Error 0.42
|
6.62 score on a scale
Standard Error 0.43
|
SECONDARY outcome
Timeframe: 5 Weeks [Baseline (Day 84) to Day 119]Population: Intent-to-Treat - Randomized. Subjects in the Open Label Phase of the study who discontinued the study prior to the Randomization Phase and/or did not meet the criteria for randomization are not included in this analysis as they were not randomized to a treatment group.
'Average' pain experienced in the past 24 hours. The Brief Pain Inventory (BPI): Scale: 0 = No Pain, 10 = Pain as bad as you can imagine; a high score indicates a worse outcome.
Outcome measures
| Measure |
Hydromorphone Hydrochloride (Randomized/Double-Blind)
n=41 Participants
Subjects on hydromorphone hydrochloride for the duration of therapy.
Hydromorphone Hydrochloride: Opioid for chronic pain
Programmable Implantable pump: Programmable Implantable pump delivering intrathecal hydromorphone
|
Hydromorphone Hydrochloride Titrated Downward/Control (Randomized/Double-Blind)
n=40 Participants
Hydromorphone Hydrochloride/Control Titrated Downward
Hydromorphone Hydrochloride: Opioid for chronic pain
Programmable Implantable pump: Programmable Implantable pump delivering intrathecal hydromorphone
|
|---|---|---|
|
Brief Pain Inventory (BPI): Pain Severity "Average"
|
4.09 score on a scale
Standard Error 0.34
|
4.78 score on a scale
Standard Error 0.35
|
SECONDARY outcome
Timeframe: 5 Weeks [Baseline (Day 84) to Day 119]Population: Intent-to-Treat - Randomized. Subjects in the Open Label Phase of the study who discontinued the study prior to the Randomization Phase and/or did not meet the criteria for randomization are not included in this analysis as they were not randomized to a treatment group.
Pain severity will be evaluated by rating pain on a scale from 0 (no pain) to 10 (pain as bad as you can imagine) for the 'worst', 'least', and 'average' pain experienced in the past 24 hours, as well as, the pain experienced 'now'. In addition, a calculated mean pain severity score will be based on the sum of all 4 of the pain scores divided by 4. If any of the 4 questions are missing, then the calculated mean pain severity score will be considered missing. High values indicate worse outcome.
Outcome measures
| Measure |
Hydromorphone Hydrochloride (Randomized/Double-Blind)
n=41 Participants
Subjects on hydromorphone hydrochloride for the duration of therapy.
Hydromorphone Hydrochloride: Opioid for chronic pain
Programmable Implantable pump: Programmable Implantable pump delivering intrathecal hydromorphone
|
Hydromorphone Hydrochloride Titrated Downward/Control (Randomized/Double-Blind)
n=40 Participants
Hydromorphone Hydrochloride/Control Titrated Downward
Hydromorphone Hydrochloride: Opioid for chronic pain
Programmable Implantable pump: Programmable Implantable pump delivering intrathecal hydromorphone
|
|---|---|---|
|
Brief Pain Inventory (BPI): Pain Severity Summary Measure
|
4.19 score on scale
Standard Error 0.35
|
5.24 score on scale
Standard Error 0.36
|
SECONDARY outcome
Timeframe: 5 Weeks [Baseline (Day 84) to Day 119]Population: Intent-to-Treat - Randomized. Subjects in the Open Label Phase of the study who discontinued the study prior to the Randomization Phase and/or did not meet the criteria for randomization are not included in this analysis as they were not randomized to a treatment group.
Pain interference with daily functioning will be evaluated by rating interference on a scale from 0 (does not interfere) to 10 (completely interferes) for 'general activity', 'mood', 'walking ability', 'normal work', 'relation with other people', 'sleep', and 'enjoyment of life'. A calculated mean pain interference will be based on the sum of non-missing interference questions answered divided by the number of questions answered. The mean should be set to missing if fewer than 4 pain interference questions are answered. A high score is worse.
Outcome measures
| Measure |
Hydromorphone Hydrochloride (Randomized/Double-Blind)
n=41 Participants
Subjects on hydromorphone hydrochloride for the duration of therapy.
Hydromorphone Hydrochloride: Opioid for chronic pain
Programmable Implantable pump: Programmable Implantable pump delivering intrathecal hydromorphone
|
Hydromorphone Hydrochloride Titrated Downward/Control (Randomized/Double-Blind)
n=40 Participants
Hydromorphone Hydrochloride/Control Titrated Downward
Hydromorphone Hydrochloride: Opioid for chronic pain
Programmable Implantable pump: Programmable Implantable pump delivering intrathecal hydromorphone
|
|---|---|---|
|
Brief Pain Inventory: Interference With Function Summary Measure
|
3.76 score on scale
Standard Error 0.44
|
5.54 score on scale
Standard Error 0.45
|
SECONDARY outcome
Timeframe: 5 Weeks [Baseline (Day 84) to Day 119]Population: Intent-to-Treat - Randomized. Subjects in the Open Label Phase of the study who discontinued the study prior to the Randomization Phase and/or did not meet the criteria for randomization are not included in this analysis as they were not randomized to a treatment group.
The SF-MPQ consists of a 15 item pain rating index. The severity of each item will be scored as None (0), Mild (1), Moderate (2), or Severe (3). The total SF-MPQ score is the sum of the severity scores for each item. The total score can range from 0 to 45; high score is worse.
Outcome measures
| Measure |
Hydromorphone Hydrochloride (Randomized/Double-Blind)
n=41 Participants
Subjects on hydromorphone hydrochloride for the duration of therapy.
Hydromorphone Hydrochloride: Opioid for chronic pain
Programmable Implantable pump: Programmable Implantable pump delivering intrathecal hydromorphone
|
Hydromorphone Hydrochloride Titrated Downward/Control (Randomized/Double-Blind)
n=40 Participants
Hydromorphone Hydrochloride/Control Titrated Downward
Hydromorphone Hydrochloride: Opioid for chronic pain
Programmable Implantable pump: Programmable Implantable pump delivering intrathecal hydromorphone
|
|---|---|---|
|
Short-Form McGill Pain Questionnaire (SF-MPQ): Summary Score
|
11.05 score on a scale, summed across 15 quest
Standard Error 1.53
|
16.95 score on a scale, summed across 15 quest
Standard Error 1.55
|
SECONDARY outcome
Timeframe: 5 Weeks [Baseline (Day 84) to Day 119]Population: Intent-to-Treat - Randomized. Subjects in the Open Label Phase of the study who discontinued the study prior to the Randomization Phase and/or did not meet the criteria for randomization are not included in this analysis as they were not randomized to a treatment group.
The number of days to rescue will be calculated by calculating the number of hours between the time of randomization and the time of rescue. The number of hours will then be divided by 24 to obtain the number of days.
Outcome measures
| Measure |
Hydromorphone Hydrochloride (Randomized/Double-Blind)
n=41 Participants
Subjects on hydromorphone hydrochloride for the duration of therapy.
Hydromorphone Hydrochloride: Opioid for chronic pain
Programmable Implantable pump: Programmable Implantable pump delivering intrathecal hydromorphone
|
Hydromorphone Hydrochloride Titrated Downward/Control (Randomized/Double-Blind)
n=40 Participants
Hydromorphone Hydrochloride/Control Titrated Downward
Hydromorphone Hydrochloride: Opioid for chronic pain
Programmable Implantable pump: Programmable Implantable pump delivering intrathecal hydromorphone
|
|---|---|---|
|
Time to Rescue Medication After Randomization (Days)
|
28.85 days
Standard Deviation 6.32
|
24.35 days
Standard Deviation 9.67
|
SECONDARY outcome
Timeframe: 5 Weeks [Baseline (Day 84) to Day 119 / Treatment Failure]Population: Intent-to-Treat - Randomized. Subjects in the Open Label Phase of the study who discontinued the study prior to the Randomization Phase and/or did not meet the criteria for randomization are not included in this analysis as they were not randomized to a treatment group.
The PGIC rating represents observed changes (if any) from the subject's Baseline Visit in activity limitations, symptoms, emotions, and overall quality of life, related to the subject's painful condition. Change is rated on a 7-point Likert-type scale from 1 (no change) through 7 (a great deal better). High score is better outcome.
Outcome measures
| Measure |
Hydromorphone Hydrochloride (Randomized/Double-Blind)
n=41 Participants
Subjects on hydromorphone hydrochloride for the duration of therapy.
Hydromorphone Hydrochloride: Opioid for chronic pain
Programmable Implantable pump: Programmable Implantable pump delivering intrathecal hydromorphone
|
Hydromorphone Hydrochloride Titrated Downward/Control (Randomized/Double-Blind)
n=40 Participants
Hydromorphone Hydrochloride/Control Titrated Downward
Hydromorphone Hydrochloride: Opioid for chronic pain
Programmable Implantable pump: Programmable Implantable pump delivering intrathecal hydromorphone
|
|---|---|---|
|
Patient Global Impression of Change (PGIC)
|
4.95 score on a scale
Standard Deviation 1.70
|
3.73 score on a scale
Standard Deviation 2.04
|
SECONDARY outcome
Timeframe: 5 Weeks [Baseline (Day 84) to Day 119]Population: Intent-to-Treat - Randomized. Subjects in the Open Label Phase of the study who discontinued the study prior to the Randomization Phase and/or did not meet the criteria for randomization are not included in this analysis as they were not randomized to a treatment group.
Total consumption (mg) = The total number of milligrams consumed of any oral opioid product from Day 84 (Baseline) through the end of study will be calculated for each subject.
Outcome measures
| Measure |
Hydromorphone Hydrochloride (Randomized/Double-Blind)
n=41 Participants
Subjects on hydromorphone hydrochloride for the duration of therapy.
Hydromorphone Hydrochloride: Opioid for chronic pain
Programmable Implantable pump: Programmable Implantable pump delivering intrathecal hydromorphone
|
Hydromorphone Hydrochloride Titrated Downward/Control (Randomized/Double-Blind)
n=40 Participants
Hydromorphone Hydrochloride/Control Titrated Downward
Hydromorphone Hydrochloride: Opioid for chronic pain
Programmable Implantable pump: Programmable Implantable pump delivering intrathecal hydromorphone
|
|---|---|---|
|
Oral Opioid Supplement Consumption
|
6916.88 milligrams (mg)
Standard Deviation 14102.91
|
1732.84 milligrams (mg)
Standard Deviation 5984.53
|
SECONDARY outcome
Timeframe: 5 Weeks [Baseline (Day 84) to Day 119]Population: Intent-to-Treat - Randomized. Subjects in the Open Label Phase of the study who discontinued the study prior to the Randomization Phase and/or did not meet the criteria for randomization are not included in this analysis as they were not randomized to a treatment group.
Number of subjects with rescue medication given
Outcome measures
| Measure |
Hydromorphone Hydrochloride (Randomized/Double-Blind)
n=41 Participants
Subjects on hydromorphone hydrochloride for the duration of therapy.
Hydromorphone Hydrochloride: Opioid for chronic pain
Programmable Implantable pump: Programmable Implantable pump delivering intrathecal hydromorphone
|
Hydromorphone Hydrochloride Titrated Downward/Control (Randomized/Double-Blind)
n=40 Participants
Hydromorphone Hydrochloride/Control Titrated Downward
Hydromorphone Hydrochloride: Opioid for chronic pain
Programmable Implantable pump: Programmable Implantable pump delivering intrathecal hydromorphone
|
|---|---|---|
|
Time to Rescue - Rescue Medication Given
|
16 Participants
|
27 Participants
|
Adverse Events
Hydromorphone Hydrochloride (Randomized/Double-Blind)
Serious events: 2 serious events
Other events: 35 other events
Deaths: 0 deaths
Hydromorphone Titrated Downward/Control (Randomized/Double-Blind)
Serious events: 6 serious events
Other events: 36 other events
Deaths: 0 deaths
Not Randomized (Open Label Only)
Serious events: 9 serious events
Other events: 56 other events
Deaths: 0 deaths
All Subjects
Serious events: 17 serious events
Other events: 127 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Hydromorphone Hydrochloride (Randomized/Double-Blind)
n=41 participants at risk
Subjects stay on their current dose of Hydromorphone Hydrochloride administered via intrathecal (IT) pump; depending on the subject's starting dose on hydromorphone hydrochloride, either a 2 mg/mL or 10 mg/mL formulation may be used.
Hydromorphone Hydrochloride: Opioid for chronic pain
Device: Programmable Implantable pump delivering intrathecal hydromorphone hydrochloride
|
Hydromorphone Titrated Downward/Control (Randomized/Double-Blind)
n=40 participants at risk
Subjects have their current dose of Hydromorphone Hydrochloride dose titrated downward; administered via Intrathecal pump
Hydromorphone Hydrochloride: Opioid for chronic pain
Device: Programmable Implantable pump delivering intrathecal hydromorphone hydrochloride
|
Not Randomized (Open Label Only)
n=72 participants at risk
Enrolled but not randomized \[Entered Open Label Phase includes visits from Day 1 until date of randomization (Day 84)\]
|
All Subjects
n=153 participants at risk
Total serious adverse events from Day 1 through end of study
|
|---|---|---|---|---|
|
Nervous system disorders
Akathisia
|
0.00%
0/41 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
2.5%
1/40 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
0.00%
0/72 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
0.65%
1/153 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
|
Nervous system disorders
Basal Ganglia Stroke
|
2.4%
1/41 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
0.00%
0/40 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
0.00%
0/72 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
0.65%
1/153 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
|
Nervous system disorders
Headache
|
0.00%
0/41 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
2.5%
1/40 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
0.00%
0/72 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
0.65%
1/153 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/41 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
0.00%
0/40 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
1.4%
1/72 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
0.65%
1/153 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/41 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
0.00%
0/40 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
1.4%
1/72 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
0.65%
1/153 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
|
Nervous system disorders
Radiculopathy
|
0.00%
0/41 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
0.00%
0/40 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
1.4%
1/72 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
0.65%
1/153 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
|
Nervous system disorders
Syncope
|
0.00%
0/41 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
0.00%
0/40 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
1.4%
1/72 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
0.65%
1/153 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
|
General disorders
Drug Withdrawal Syndrome
|
0.00%
0/41 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
5.0%
2/40 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
0.00%
0/72 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
1.3%
2/153 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
|
General disorders
Drug Intolerance
|
0.00%
0/41 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
0.00%
0/40 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
1.4%
1/72 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
0.65%
1/153 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
|
General disorders
Non-Cardiac Chest Pain
|
0.00%
0/41 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
0.00%
0/40 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
1.4%
1/72 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
0.65%
1/153 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
|
Infections and infestations
Clostridium Difficile Colitis
|
0.00%
0/41 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
0.00%
0/40 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
1.4%
1/72 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
0.65%
1/153 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
|
Infections and infestations
Implant Site Abscess
|
0.00%
0/41 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
0.00%
0/40 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
1.4%
1/72 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
0.65%
1/153 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
|
Infections and infestations
Implant Site Cellulitis
|
0.00%
0/41 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
0.00%
0/40 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
1.4%
1/72 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
0.65%
1/153 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
|
Infections and infestations
Incision Site Infection
|
0.00%
0/41 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
0.00%
0/40 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
1.4%
1/72 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
0.65%
1/153 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/41 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
2.5%
1/40 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
0.00%
0/72 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
0.65%
1/153 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
|
Injury, poisoning and procedural complications
Craniocerebral Injury
|
2.4%
1/41 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
0.00%
0/40 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
1.4%
1/72 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
1.3%
2/153 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
|
Injury, poisoning and procedural complications
Cervical Vertebral Fracture
|
2.4%
1/41 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
0.00%
0/40 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
0.00%
0/72 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
0.65%
1/153 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
|
Injury, poisoning and procedural complications
Seroma
|
0.00%
0/41 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
0.00%
0/40 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
1.4%
1/72 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
0.65%
1/153 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/41 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
2.5%
1/40 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
1.4%
1/72 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
1.3%
2/153 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
|
Cardiac disorders
Angina Unstable
|
0.00%
0/41 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
2.5%
1/40 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
0.00%
0/72 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
0.65%
1/153 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
|
Gastrointestinal disorders
Oesophageal Achalasia
|
0.00%
0/41 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
0.00%
0/40 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
1.4%
1/72 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
0.65%
1/153 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/41 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
0.00%
0/40 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
1.4%
1/72 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
0.65%
1/153 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
Other adverse events
| Measure |
Hydromorphone Hydrochloride (Randomized/Double-Blind)
n=41 participants at risk
Subjects stay on their current dose of Hydromorphone Hydrochloride administered via intrathecal (IT) pump; depending on the subject's starting dose on hydromorphone hydrochloride, either a 2 mg/mL or 10 mg/mL formulation may be used.
Hydromorphone Hydrochloride: Opioid for chronic pain
Device: Programmable Implantable pump delivering intrathecal hydromorphone hydrochloride
|
Hydromorphone Titrated Downward/Control (Randomized/Double-Blind)
n=40 participants at risk
Subjects have their current dose of Hydromorphone Hydrochloride dose titrated downward; administered via Intrathecal pump
Hydromorphone Hydrochloride: Opioid for chronic pain
Device: Programmable Implantable pump delivering intrathecal hydromorphone hydrochloride
|
Not Randomized (Open Label Only)
n=72 participants at risk
Enrolled but not randomized \[Entered Open Label Phase includes visits from Day 1 until date of randomization (Day 84)\]
|
All Subjects
n=153 participants at risk
Total serious adverse events from Day 1 through end of study
|
|---|---|---|---|---|
|
Vascular disorders
Hypertension
|
2.4%
1/41 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
7.5%
3/40 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
2.8%
2/72 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
3.9%
6/153 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
|
Injury, poisoning and procedural complications
Thermal Burn
|
0.00%
0/41 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
5.0%
2/40 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
0.00%
0/72 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
1.3%
2/153 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
2.4%
1/41 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
7.5%
3/40 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
0.00%
0/72 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
2.6%
4/153 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
12.2%
5/41 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
22.5%
9/40 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
9.7%
7/72 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
13.7%
21/153 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.9%
2/41 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
7.5%
3/40 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
8.3%
6/72 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
7.2%
11/153 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
0.00%
0/41 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
12.5%
5/40 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
6.9%
5/72 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
6.5%
10/153 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
4.9%
2/41 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
5.0%
2/40 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
5.6%
4/72 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
5.2%
8/153 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
7.3%
3/41 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
5.0%
2/40 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
2.8%
2/72 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
4.6%
7/153 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
2.4%
1/41 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
5.0%
2/40 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
1.4%
1/72 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
2.6%
4/153 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
|
Musculoskeletal and connective tissue disorders
Sacroiliitis
|
0.00%
0/41 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
5.0%
2/40 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
0.00%
0/72 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
1.3%
2/153 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
|
General disorders
Drug Withdrawal Syndrome
|
7.3%
3/41 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
27.5%
11/40 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
11.1%
8/72 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
14.4%
22/153 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
|
General disorders
Pain
|
7.3%
3/41 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
12.5%
5/40 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
4.2%
3/72 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
7.2%
11/153 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
|
General disorders
Oedema Peripheral
|
7.3%
3/41 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
2.5%
1/40 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
4.2%
3/72 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
4.6%
7/153 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
|
General disorders
Chills
|
2.4%
1/41 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
5.0%
2/40 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
1.4%
1/72 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
2.6%
4/153 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
|
General disorders
Oedema
|
4.9%
2/41 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
5.0%
2/40 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
0.00%
0/72 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
2.6%
4/153 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
|
General disorders
Chest Pain
|
0.00%
0/41 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
5.0%
2/40 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
1.4%
1/72 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
2.0%
3/153 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
|
General disorders
Asthenia
|
0.00%
0/41 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
5.0%
2/40 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
0.00%
0/72 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
1.3%
2/153 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
|
Gastrointestinal disorders
Nausea
|
29.3%
12/41 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
37.5%
15/40 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
11.1%
8/72 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
22.9%
35/153 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
|
Gastrointestinal disorders
Diarrhoea
|
9.8%
4/41 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
25.0%
10/40 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
4.2%
3/72 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
11.1%
17/153 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
|
Gastrointestinal disorders
Vomiting
|
7.3%
3/41 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
17.5%
7/40 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
2.8%
2/72 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
7.8%
12/153 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
|
Gastrointestinal disorders
Constipation
|
4.9%
2/41 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
12.5%
5/40 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
1.4%
1/72 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
5.2%
8/153 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
2.4%
1/41 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
5.0%
2/40 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
0.00%
0/72 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
2.0%
3/153 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.00%
0/41 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
5.0%
2/40 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
1.4%
1/72 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
2.0%
3/153 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
|
Nervous system disorders
Headache
|
9.8%
4/41 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
10.0%
4/40 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
8.3%
6/72 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
9.2%
14/153 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
|
Nervous system disorders
Somnolence
|
4.9%
2/41 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
2.5%
1/40 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
5.6%
4/72 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
4.6%
7/153 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
|
Nervous system disorders
Sciatica
|
0.00%
0/41 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
5.0%
2/40 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
4.2%
3/72 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
3.3%
5/153 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
|
Nervous system disorders
Lethargy
|
2.4%
1/41 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
5.0%
2/40 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
0.00%
0/72 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
2.0%
3/153 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/41 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
5.0%
2/40 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
0.00%
0/72 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
1.3%
2/153 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
|
Infections and infestations
Bronchitis
|
7.3%
3/41 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
5.0%
2/40 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
4.2%
3/72 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
5.2%
8/153 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
|
Infections and infestations
Gastroenteritis Viral
|
2.4%
1/41 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
7.5%
3/40 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
2.8%
2/72 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
3.9%
6/153 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
|
Infections and infestations
Sinusitis
|
7.3%
3/41 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
2.5%
1/40 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
2.8%
2/72 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
3.9%
6/153 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
7.3%
3/41 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
2.5%
1/40 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
0.00%
0/72 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
2.6%
4/153 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
7.3%
3/41 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
7.5%
3/40 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
2.8%
2/72 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
5.2%
8/153 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
|
Psychiatric disorders
Anxiety
|
2.4%
1/41 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
10.0%
4/40 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
2.8%
2/72 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
4.6%
7/153 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
|
Injury, poisoning and procedural complications
Contusion
|
4.9%
2/41 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
5.0%
2/40 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
2.8%
2/72 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
3.9%
6/153 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
|
Injury, poisoning and procedural complications
Fall
|
2.4%
1/41 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
7.5%
3/40 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
0.00%
0/72 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
2.6%
4/153 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
|
Injury, poisoning and procedural complications
Joint Injury
|
7.3%
3/41 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
0.00%
0/40 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
0.00%
0/72 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
2.0%
3/153 • 24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
|
Additional Information
Heather Kapushoc, Sr. Biostatistician
CTI Clinical Trial and Consulting Services
Phone: 571-315-2574
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place