Trial Outcomes & Findings for Safety and Efficacy Study of Osmotic Release Oral System (OROS) Hydromorphone in Participants With Cancer Pain (NCT NCT01648699)
NCT ID: NCT01648699
Last Updated: 2013-10-11
Results Overview
The Brief Pain Inventory (BPI) assesses the severity of pain and the impact of pain on daily functions (interference items). The severity items are scored from 0=no pain and 10=pain as bad as you can imagine. The interference items are scored from 0=no interference and 10=interferes completely.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
20 participants
Primary outcome timeframe
Baseline
Results posted on
2013-10-11
Participant Flow
Participant milestones
| Measure |
Osmotic Release Oral System (OROS) Hydromorphone
Osmotic Release Oral System (OROS) Hydromorphone was administered as either 8, 12, 16, 20, 24, 32, 36 or 40 milligram (mg) oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days and not more than 40 mg. The study drug was administered up to 28 days.
|
|---|---|
|
Overall Study
STARTED
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20
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Osmotic Release Oral System (OROS) Hydromorphone
Osmotic Release Oral System (OROS) Hydromorphone was administered as either 8, 12, 16, 20, 24, 32, 36 or 40 milligram (mg) oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days and not more than 40 mg. The study drug was administered up to 28 days.
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|---|---|
|
Overall Study
Death
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
|
Overall Study
Unspecified/unable to complete 4 visits
|
2
|
Baseline Characteristics
Safety and Efficacy Study of Osmotic Release Oral System (OROS) Hydromorphone in Participants With Cancer Pain
Baseline characteristics by cohort
| Measure |
Osmotic Release Oral System (OROS) Hydromorphone
n=20 Participants
Osmotic Release Oral System (OROS) Hydromorphone was administered as either 8, 12, 16, 20, 24, 32, 36 or 40 milligram (mg) oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days and not more than 40 mg. The study drug was administered up to 28 days.
|
|---|---|
|
Age Continuous
|
50.35 Years
STANDARD_DEVIATION 11.03 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: Intent-to-treat (ITT) population included all participants who received at least one dose of study medication at Baseline.
The Brief Pain Inventory (BPI) assesses the severity of pain and the impact of pain on daily functions (interference items). The severity items are scored from 0=no pain and 10=pain as bad as you can imagine. The interference items are scored from 0=no interference and 10=interferes completely.
Outcome measures
| Measure |
OROS Hydromorphone 8 Milligram (mg)
n=5 Participants
OROS Hydromorphone was administered as 8 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
|
OROS Hydromorphone 12 mg
n=6 Participants
OROS Hydromorphone was administered as 12 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
|
OROS Hydromorphone 16 mg
n=3 Participants
OROS Hydromorphone was administered as 16 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
|
OROS Hydromorphone 20 mg
n=2 Participants
OROS Hydromorphone was administered as 20 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
|
OROS Hydromorphone 24 mg
n=1 Participants
OROS Hydromorphone was administered as 24 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
|
OROS Hydromorphone 32 mg
n=1 Participants
OROS Hydromorphone was administered as 32 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
|
OROS Hydromorphone 36 mg
n=2 Participants
OROS Hydromorphone was administered as 36 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
|
OROS Hydromorphone (No Dose Indicated)
OROS Hydromorphone was administered as either 8, 12, 16, 20, 24, 32, 36 or 40 mg oral tablet once daily in the morning for 28 days, as the dose was not indicated for these participants.
|
|---|---|---|---|---|---|---|---|---|
|
Brief Pain Inventory (BPI) Average Score at Baseline
Severity item: Least pain in last 24 hours
|
2.60 Units on a scale
Standard Deviation 2.70
|
1.00 Units on a scale
Standard Deviation 1.67
|
1.00 Units on a scale
Standard Deviation 1.73
|
3.00 Units on a scale
Standard Deviation 1.41
|
0.00 Units on a scale
Standard Deviation 0.00
|
3.0 Units on a scale
Standard Deviation 0.00
|
3.5 Units on a scale
Standard Deviation 4.95
|
—
|
|
Brief Pain Inventory (BPI) Average Score at Baseline
Severity item: Average pain
|
5.50 Units on a scale
Standard Deviation 2.78
|
2.50 Units on a scale
Standard Deviation 1.97
|
3.00 Units on a scale
Standard Deviation 2.65
|
5.50 Units on a scale
Standard Deviation 0.71
|
1.00 Units on a scale
Standard Deviation 0.00
|
5.0 Units on a scale
Standard Deviation 0.00
|
3.5 Units on a scale
Standard Deviation 4.95
|
—
|
|
Brief Pain Inventory (BPI) Average Score at Baseline
Interference item: Mood
|
7.00 Units on a scale
Standard Deviation 1.87
|
3.00 Units on a scale
Standard Deviation 2.37
|
5.33 Units on a scale
Standard Deviation 4.73
|
6.00 Units on a scale
Standard Deviation 1.41
|
5.00 Units on a scale
Standard Deviation 0.00
|
7.00 Units on a scale
Standard Deviation 0.00
|
6.00 Units on a scale
Standard Deviation 1.41
|
—
|
|
Brief Pain Inventory (BPI) Average Score at Baseline
Interference item: Normal work
|
5.00 Units on a scale
Standard Deviation 3.61
|
5.83 Units on a scale
Standard Deviation 4.12
|
6.33 Units on a scale
Standard Deviation 5.51
|
9.00 Units on a scale
Standard Deviation 1.41
|
0.00 Units on a scale
Standard Deviation 0.00
|
9.00 Units on a scale
Standard Deviation 0.00
|
9.00 Units on a scale
Standard Deviation 1.41
|
—
|
|
Brief Pain Inventory (BPI) Average Score at Baseline
Interference item: Sleep
|
6.80 Units on a scale
Standard Deviation 3.83
|
2.33 Units on a scale
Standard Deviation 3.20
|
2.67 Units on a scale
Standard Deviation 4.62
|
8.00 Units on a scale
Standard Deviation 0.00
|
0.00 Units on a scale
Standard Deviation 0.00
|
5.00 Units on a scale
Standard Deviation 0.00
|
4.50 Units on a scale
Standard Deviation 4.95
|
—
|
|
Brief Pain Inventory (BPI) Average Score at Baseline
Interference item: Enjoyment of life
|
5.40 Units on a scale
Standard Deviation 4.51
|
3.17 Units on a scale
Standard Deviation 4.02
|
5.00 Units on a scale
Standard Deviation 4.36
|
7.50 Units on a scale
Standard Deviation 0.71
|
7.00 Units on a scale
Standard Deviation 0.00
|
8.00 Units on a scale
Standard Deviation 0.00
|
4.00 Units on a scale
Standard Deviation 5.66
|
—
|
|
Brief Pain Inventory (BPI) Average Score at Baseline
Severity item: Worst pain in last 24 hours
|
7.40 Units on a scale
Standard Deviation 1.82
|
6.50 Units on a scale
Standard Deviation 3.45
|
4.00 Units on a scale
Standard Deviation 4.00
|
10.00 Units on a scale
Standard Deviation 0.00
|
2.00 Units on a scale
Standard Deviation 0.00
|
8.0 Units on a scale
Standard Deviation 0.00
|
5.0 Units on a scale
Standard Deviation 2.83
|
—
|
|
Brief Pain Inventory (BPI) Average Score at Baseline
Severity item: Pain right now
|
4.60 Units on a scale
Standard Deviation 4.03
|
2.00 Units on a scale
Standard Deviation 2.28
|
2.67 Units on a scale
Standard Deviation 3.06
|
7.00 Units on a scale
Standard Deviation 4.24
|
4.00 Units on a scale
Standard Deviation 0.00
|
3.0 Units on a scale
Standard Deviation 0.00
|
5.0 Units on a scale
Standard Deviation 4.24
|
—
|
|
Brief Pain Inventory (BPI) Average Score at Baseline
Interference item: General activity
|
6.20 Units on a scale
Standard Deviation 4.27
|
4.50 Units on a scale
Standard Deviation 3.39
|
4.33 Units on a scale
Standard Deviation 3.79
|
6.50 Units on a scale
Standard Deviation 2.12
|
0.00 Units on a scale
Standard Deviation 0.00
|
8.0 Units on a scale
Standard Deviation 0.00
|
7.0 Units on a scale
Standard Deviation 1.41
|
—
|
|
Brief Pain Inventory (BPI) Average Score at Baseline
Interference item: Walking ability
|
7.40 Units on a scale
Standard Deviation 1.82
|
4.17 Units on a scale
Standard Deviation 4.22
|
5.33 Units on a scale
Standard Deviation 4.62
|
8.00 Units on a scale
Standard Deviation 2.83
|
3.00 Units on a scale
Standard Deviation 0.00
|
7.00 Units on a scale
Standard Deviation 0.00
|
6.50 Units on a scale
Standard Deviation 0.71
|
—
|
|
Brief Pain Inventory (BPI) Average Score at Baseline
Interference item: Relationships with other people
|
3.00 Units on a scale
Standard Deviation 3.74
|
2.33 Units on a scale
Standard Deviation 3.88
|
3.33 Units on a scale
Standard Deviation 4.16
|
6.50 Units on a scale
Standard Deviation 4.95
|
8.00 Units on a scale
Standard Deviation 0.00
|
9.00 Units on a scale
Standard Deviation 0.00
|
4.50 Units on a scale
Standard Deviation 4.95
|
—
|
PRIMARY outcome
Timeframe: Day 28Population: ITT population included all participants who received at least one dose of study medication at Baseline. 'N ' (number of participants analyzed) signifies the participants evaluable for this measure.
The BPI assesses the severity of pain and the impact of pain on daily functions (interference items). The severity items are scored from 0=no pain and 10=pain as bad as you can imagine. The interference items are scored from 0=no interference and 10=interferes completely.
Outcome measures
| Measure |
OROS Hydromorphone 8 Milligram (mg)
n=1 Participants
OROS Hydromorphone was administered as 8 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
|
OROS Hydromorphone 12 mg
n=5 Participants
OROS Hydromorphone was administered as 12 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
|
OROS Hydromorphone 16 mg
n=1 Participants
OROS Hydromorphone was administered as 16 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
|
OROS Hydromorphone 20 mg
n=2 Participants
OROS Hydromorphone was administered as 20 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
|
OROS Hydromorphone 24 mg
n=1 Participants
OROS Hydromorphone was administered as 24 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
|
OROS Hydromorphone 32 mg
n=3 Participants
OROS Hydromorphone was administered as 32 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
|
OROS Hydromorphone 36 mg
n=1 Participants
OROS Hydromorphone was administered as 36 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
|
OROS Hydromorphone (No Dose Indicated)
OROS Hydromorphone was administered as either 8, 12, 16, 20, 24, 32, 36 or 40 mg oral tablet once daily in the morning for 28 days, as the dose was not indicated for these participants.
|
|---|---|---|---|---|---|---|---|---|
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Brief Pain Inventory (BPI) Average Score at Day 28
Severity item: Average pain
|
2.00 Units on a scale
Standard Deviation 0.00
|
2.40 Units on a scale
Standard Deviation 3.21
|
0.00 Units on a scale
Standard Deviation 0.00
|
1.50 Units on a scale
Standard Deviation 2.12
|
0.00 Units on a scale
Standard Deviation 0.00
|
5.33 Units on a scale
Standard Deviation 3.06
|
4.00 Units on a scale
Standard Deviation 0.00
|
—
|
|
Brief Pain Inventory (BPI) Average Score at Day 28
Interference item: General activity
|
2.00 Units on a scale
Standard Deviation 0.00
|
4.20 Units on a scale
Standard Deviation 4.60
|
0.00 Units on a scale
Standard Deviation 0.00
|
5.00 Units on a scale
Standard Deviation 7.07
|
0.00 Units on a scale
Standard Deviation 0.00
|
7.33 Units on a scale
Standard Deviation 4.62
|
7.00 Units on a scale
Standard Deviation 0.00
|
—
|
|
Brief Pain Inventory (BPI) Average Score at Day 28
Interference item: Mood
|
2.00 Units on a scale
Standard Deviation 0.00
|
1.80 Units on a scale
Standard Deviation 3.03
|
0.00 Units on a scale
Standard Deviation 0.00
|
5.00 Units on a scale
Standard Deviation 7.07
|
0.00 Units on a scale
Standard Deviation 0.00
|
4.67 Units on a scale
Standard Deviation 2.89
|
7.00 Units on a scale
Standard Deviation 0.00
|
—
|
|
Brief Pain Inventory (BPI) Average Score at Day 28
Interference item: Normal work
|
2.00 Units on a scale
Standard Deviation 0.00
|
3.20 Units on a scale
Standard Deviation 4.32
|
0.00 Units on a scale
Standard Deviation 0.00
|
5.00 Units on a scale
Standard Deviation 7.07
|
0.00 Units on a scale
Standard Deviation 0.00
|
8.00 Units on a scale
Standard Deviation 3.46
|
7.00 Units on a scale
Standard Deviation 0.00
|
—
|
|
Brief Pain Inventory (BPI) Average Score at Day 28
Interference item: Enjoyment of life
|
1.00 Units on a scale
Standard Deviation 0.00
|
1.20 Units on a scale
Standard Deviation 2.17
|
0.00 Units on a scale
Standard Deviation 0.00
|
4.00 Units on a scale
Standard Deviation 5.66
|
0.00 Units on a scale
Standard Deviation 0.00
|
5.33 Units on a scale
Standard Deviation 4.04
|
5.00 Units on a scale
Standard Deviation 0.00
|
—
|
|
Brief Pain Inventory (BPI) Average Score at Day 28
Severity item: Worst pain in last 24 hours
|
2.00 Units on a scale
Standard Deviation 0.00
|
3.20 Units on a scale
Standard Deviation 3.35
|
0.00 Units on a scale
Standard Deviation 0.00
|
4.00 Units on a scale
Standard Deviation 5.66
|
4.00 Units on a scale
Standard Deviation 0.00
|
7.00 Units on a scale
Standard Deviation 3.61
|
7.00 Units on a scale
Standard Deviation 0.00
|
—
|
|
Brief Pain Inventory (BPI) Average Score at Day 28
Severity item: Least pain in last 24 hours
|
0.00 Units on a scale
Standard Deviation 0.00
|
2.40 Units on a scale
Standard Deviation 3.05
|
0.00 Units on a scale
Standard Deviation 0.00
|
1.50 Units on a scale
Standard Deviation 2.12
|
0.00 Units on a scale
Standard Deviation 0.00
|
3.67 Units on a scale
Standard Deviation 4.04
|
3.00 Units on a scale
Standard Deviation 0.00
|
—
|
|
Brief Pain Inventory (BPI) Average Score at Day 28
Severity item: Pain right now
|
2.00 Units on a scale
Standard Deviation 0.00
|
1.00 Units on a scale
Standard Deviation 2.24
|
0.00 Units on a scale
Standard Deviation 0.00
|
0.00 Units on a scale
Standard Deviation 0.00
|
0.00 Units on a scale
Standard Deviation 0.00
|
6.67 Units on a scale
Standard Deviation 4.04
|
3.00 Units on a scale
Standard Deviation 0.00
|
—
|
|
Brief Pain Inventory (BPI) Average Score at Day 28
Interference item: Talking ability
|
0.00 Units on a scale
Standard Deviation 0.00
|
4.00 Units on a scale
Standard Deviation 4.69
|
0.00 Units on a scale
Standard Deviation 0.00
|
5.00 Units on a scale
Standard Deviation 7.07
|
0.00 Units on a scale
Standard Deviation 0.00
|
8.00 Units on a scale
Standard Deviation 3.46
|
7.00 Units on a scale
Standard Deviation 0.00
|
—
|
|
Brief Pain Inventory (BPI) Average Score at Day 28
Interference item: Relationships with other people
|
1.00 Units on a scale
Standard Deviation 0.00
|
1.80 Units on a scale
Standard Deviation 3.49
|
0.00 Units on a scale
Standard Deviation 0.00
|
5.00 Units on a scale
Standard Deviation 7.07
|
0.00 Units on a scale
Standard Deviation 0.00
|
5.00 Units on a scale
Standard Deviation 4.58
|
5.00 Units on a scale
Standard Deviation 0.00
|
—
|
|
Brief Pain Inventory (BPI) Average Score at Day 28
Interference item: Sleep
|
1.00 Units on a scale
Standard Deviation 0.00
|
2.60 Units on a scale
Standard Deviation 3.44
|
0.00 Units on a scale
Standard Deviation 0.00
|
2.00 Units on a scale
Standard Deviation 2.83
|
0.00 Units on a scale
Standard Deviation 0.00
|
7.33 Units on a scale
Standard Deviation 3.06
|
5.00 Units on a scale
Standard Deviation 0.00
|
—
|
SECONDARY outcome
Timeframe: Day 28Population: ITT population included all participants who received at least one dose of study medication at Baseline. 'N ' (number of participants analyzed) signifies the participants evaluable for this measure.
Rescue medication was a medication intended to relieve symptoms immediately. Rescue medication of morphine was used during the study duration and dose was set at 10-15 percent of the total daily morphine dose which ranged from 10-60 milligram.
Outcome measures
| Measure |
OROS Hydromorphone 8 Milligram (mg)
n=1 Participants
OROS Hydromorphone was administered as 8 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
|
OROS Hydromorphone 12 mg
n=5 Participants
OROS Hydromorphone was administered as 12 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
|
OROS Hydromorphone 16 mg
n=1 Participants
OROS Hydromorphone was administered as 16 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
|
OROS Hydromorphone 20 mg
n=2 Participants
OROS Hydromorphone was administered as 20 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
|
OROS Hydromorphone 24 mg
n=1 Participants
OROS Hydromorphone was administered as 24 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
|
OROS Hydromorphone 32 mg
n=2 Participants
OROS Hydromorphone was administered as 32 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
|
OROS Hydromorphone 36 mg
n=1 Participants
OROS Hydromorphone was administered as 36 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
|
OROS Hydromorphone (No Dose Indicated)
n=2 Participants
OROS Hydromorphone was administered as either 8, 12, 16, 20, 24, 32, 36 or 40 mg oral tablet once daily in the morning for 28 days, as the dose was not indicated for these participants.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants Given Rescue Pain Medications
|
1 Participants
|
4 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Day 28Population: ITT population included all participants who received at least one dose of study medication at Baseline. "n" signifies those participants who were evaluated for this measure at the specified time point. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
The Clinical Global Impression (CGI) rating scale is a 7-point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant, which ranges from "very much worse" to "very much improved" (as compared to Baseline).
Outcome measures
| Measure |
OROS Hydromorphone 8 Milligram (mg)
n=15 Participants
OROS Hydromorphone was administered as 8 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
|
OROS Hydromorphone 12 mg
OROS Hydromorphone was administered as 12 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
|
OROS Hydromorphone 16 mg
OROS Hydromorphone was administered as 16 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
|
OROS Hydromorphone 20 mg
OROS Hydromorphone was administered as 20 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
|
OROS Hydromorphone 24 mg
OROS Hydromorphone was administered as 24 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
|
OROS Hydromorphone 32 mg
OROS Hydromorphone was administered as 32 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
|
OROS Hydromorphone 36 mg
OROS Hydromorphone was administered as 36 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
|
OROS Hydromorphone (No Dose Indicated)
OROS Hydromorphone was administered as either 8, 12, 16, 20, 24, 32, 36 or 40 mg oral tablet once daily in the morning for 28 days, as the dose was not indicated for these participants.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Categorical Score on Clinical Global Impression Scale as Assessed by Clinician
Very much improved: Day 28 (n=15)
|
7 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Score on Clinical Global Impression Scale as Assessed by Clinician
Much improved: Day 28 (n=15)
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Score on Clinical Global Impression Scale as Assessed by Clinician
Minimally improved: Day 28 (n=15)
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Score on Clinical Global Impression Scale as Assessed by Clinician
No change: Day 28 (n=15)
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Score on Clinical Global Impression Scale as Assessed by Clinician
Minimally worse: Day 28 (n=15)
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Score on Clinical Global Impression Scale as Assessed by Clinician
Very much worse: Day 28 (n=15)
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Score on Clinical Global Impression Scale as Assessed by Clinician
Not evaluated: Day 28 (n=15)
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
OROS Hydromorphone
Serious events: 2 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
OROS Hydromorphone
n=20 participants at risk
OROS Hydromorphone was administered as either 8, 12, 16, 20, 24, 32, 36 or 40 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days and not more than 40 mg. The study drug was administered up to 28 days.
|
|---|---|
|
Psychiatric disorders
Agitation
|
5.0%
1/20 • Baseline up to Day 28
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
|
Skin and subcutaneous tissue disorders
Hypehidrosis
|
5.0%
1/20 • Baseline up to Day 28
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
|
Infections and infestations
Death due to sepsis
|
5.0%
1/20 • Baseline up to Day 28
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
|
Psychiatric disorders
Restlessness
|
5.0%
1/20 • Baseline up to Day 28
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
|
Nervous system disorders
Headache
|
5.0%
1/20 • Baseline up to Day 28
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
Other adverse events
| Measure |
OROS Hydromorphone
n=20 participants at risk
OROS Hydromorphone was administered as either 8, 12, 16, 20, 24, 32, 36 or 40 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days and not more than 40 mg. The study drug was administered up to 28 days.
|
|---|---|
|
Gastrointestinal disorders
Constipation
|
10.0%
2/20 • Baseline up to Day 28
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
|
Nervous system disorders
Dizziness
|
10.0%
2/20 • Baseline up to Day 28
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
|
Gastrointestinal disorders
Nausea
|
15.0%
3/20 • Baseline up to Day 28
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
|
General disorders
Oedema peripheral
|
5.0%
1/20 • Baseline up to Day 28
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
|
General disorders
Chest Discomfort
|
5.0%
1/20 • Baseline up to Day 28
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.0%
1/20 • Baseline up to Day 28
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
|
Gastrointestinal disorders
Vomiting
|
5.0%
1/20 • Baseline up to Day 28
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.0%
1/20 • Baseline up to Day 28
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
|
Nervous system disorders
Somnolence
|
5.0%
1/20 • Baseline up to Day 28
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
Additional Information
Medical Affairs Manager
Janssen Philippines
Phone: +632-8248935
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place