Pain
Conditions
Keywords
Pain, Cancer, Osmotic Release Oral System, OROS Hydromorphone, Jurnista
Brief summary
The purpose of this study is to evaluate the effectiveness and safety of Osmotic Release Oral System (OROS) hydromorphone using standardized conversion from prior opioid therapy among participants with cancer pain.
Detailed description
This is a prospective (study following participants forward in time), open-label (all people know the identity of the intervention), single-arm, multi-center (conducted in more than one center) study to evaluate the effectiveness and safety of stable dose of OROS hydromorphone among participants with cancer pain. The duration of this study will be 28 days and will include visits at: Day 0 (Baseline), Day 7, 14 and 28. The OROS hydromorphone will be administered orally for 28 days and dose titration (incremental increase in drug dosage to a level that provides the optimal therapeutic effect) will be done every two days upon administration of dose. Rescue medication (a medication intended to relieve symptoms immediately) of morphine will be permitted throughout the study duration. Efficacy of the participants will primarily be evaluated by Brief Pain Inventory score. Participants' safety will be monitored throughout the study.
Interventions
DRUGOsmotic Release Oral System (OROS) hydromorphone
OROS Hydromorphone will be 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) will be converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and dose will be increased if needed, but not more than 40 mg and not more frequently than every two days. The study drug will be administered up to 28 days.
Sponsors
Janssen Pharmaceutica
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Participant with histological confirmed malignancy * Participant on stable morphine or 25 milligram oxycodone dose equivalent per day. Stable dose is defined as no dose change for 3 consecutive days and does not require more than 3 doses of rescue medication per day * Life expectancy of at least 3 months * Negative urine pregnancy test * Participants with signed informed consent
Exclusion criteria
* Participant intolerant or hypersensitive to hydromorphone or other opioid agonist * Participant with unstable medical condition * Participant with renal dysfunction and liver dysfunction * Participant dependence to opiates * Inability to take oral medication
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Brief Pain Inventory (BPI) Average Score at Baseline | 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. |
| Brief Pain Inventory (BPI) Average Score at Day 28 | Day 28 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Given Rescue Pain Medications | Day 28 | 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. |
| Number of Participants With Categorical Score on Clinical Global Impression Scale as Assessed by Clinician | Day 28 | 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). |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 20 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Unspecified/unable to complete 4 visits | 2 |
Baseline characteristics
| Characteristic | Osmotic Release Oral System (OROS) Hydromorphone |
|---|---|
| Age Continuous | 50.35 Years STANDARD_DEVIATION 11.03 |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 9 / 20 |
| serious Total, serious adverse events | 2 / 20 |
Outcome results
Primary
Brief Pain Inventory (BPI) Average Score 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.
Time frame: Baseline
Population: Intent-to-treat (ITT) population included all participants who received at least one dose of study medication at Baseline.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| OROS Hydromorphone 8 Milligram (mg) | Brief Pain Inventory (BPI) Average Score at Baseline | Severity item: Least pain in last 24 hours | 2.60 Units on a scale | Standard Deviation 2.7 |
| OROS Hydromorphone 8 Milligram (mg) | Brief Pain Inventory (BPI) Average Score at Baseline | Interference item: Normal work | 5.00 Units on a scale | Standard Deviation 3.61 |
| OROS Hydromorphone 8 Milligram (mg) | Brief Pain Inventory (BPI) Average Score at Baseline | Interference item: Sleep | 6.80 Units on a scale | Standard Deviation 3.83 |
| OROS Hydromorphone 8 Milligram (mg) | Brief Pain Inventory (BPI) Average Score at Baseline | Severity item: Pain right now | 4.60 Units on a scale | Standard Deviation 4.03 |
| OROS Hydromorphone 8 Milligram (mg) | 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 |
| OROS Hydromorphone 8 Milligram (mg) | Brief Pain Inventory (BPI) Average Score at Baseline | Interference item: Relationships with other people | 3.00 Units on a scale | Standard Deviation 3.74 |
| OROS Hydromorphone 8 Milligram (mg) | Brief Pain Inventory (BPI) Average Score at Baseline | Interference item: General activity | 6.20 Units on a scale | Standard Deviation 4.27 |
| OROS Hydromorphone 8 Milligram (mg) | Brief Pain Inventory (BPI) Average Score at Baseline | Interference item: Mood | 7.00 Units on a scale | Standard Deviation 1.87 |
| OROS Hydromorphone 8 Milligram (mg) | Brief Pain Inventory (BPI) Average Score at Baseline | Severity item: Average pain | 5.50 Units on a scale | Standard Deviation 2.78 |
| OROS Hydromorphone 8 Milligram (mg) | Brief Pain Inventory (BPI) Average Score at Baseline | Interference item: Walking ability | 7.40 Units on a scale | Standard Deviation 1.82 |
| OROS Hydromorphone 8 Milligram (mg) | Brief Pain Inventory (BPI) Average Score at Baseline | Interference item: Enjoyment of life | 5.40 Units on a scale | Standard Deviation 4.51 |
| OROS Hydromorphone 12 mg | Brief Pain Inventory (BPI) Average Score at Baseline | Interference item: Enjoyment of life | 3.17 Units on a scale | Standard Deviation 4.02 |
| OROS Hydromorphone 12 mg | Brief Pain Inventory (BPI) Average Score at Baseline | Interference item: Mood | 3.00 Units on a scale | Standard Deviation 2.37 |
| OROS Hydromorphone 12 mg | Brief Pain Inventory (BPI) Average Score at Baseline | Interference item: Normal work | 5.83 Units on a scale | Standard Deviation 4.12 |
| OROS Hydromorphone 12 mg | Brief Pain Inventory (BPI) Average Score at Baseline | Interference item: Sleep | 2.33 Units on a scale | Standard Deviation 3.2 |
| OROS Hydromorphone 12 mg | Brief Pain Inventory (BPI) Average Score at Baseline | Severity item: Pain right now | 2.00 Units on a scale | Standard Deviation 2.28 |
| OROS Hydromorphone 12 mg | Brief Pain Inventory (BPI) Average Score at Baseline | Severity item: Worst pain in last 24 hours | 6.50 Units on a scale | Standard Deviation 3.45 |
| OROS Hydromorphone 12 mg | Brief Pain Inventory (BPI) Average Score at Baseline | Interference item: Walking ability | 4.17 Units on a scale | Standard Deviation 4.22 |
| OROS Hydromorphone 12 mg | Brief Pain Inventory (BPI) Average Score at Baseline | Severity item: Average pain | 2.50 Units on a scale | Standard Deviation 1.97 |
| OROS Hydromorphone 12 mg | Brief Pain Inventory (BPI) Average Score at Baseline | Interference item: General activity | 4.50 Units on a scale | Standard Deviation 3.39 |
| OROS Hydromorphone 12 mg | Brief Pain Inventory (BPI) Average Score at Baseline | Interference item: Relationships with other people | 2.33 Units on a scale | Standard Deviation 3.88 |
| OROS Hydromorphone 12 mg | Brief Pain Inventory (BPI) Average Score at Baseline | Severity item: Least pain in last 24 hours | 1.00 Units on a scale | Standard Deviation 1.67 |
| OROS Hydromorphone 16 mg | Brief Pain Inventory (BPI) Average Score at Baseline | Interference item: Relationships with other people | 3.33 Units on a scale | Standard Deviation 4.16 |
| OROS Hydromorphone 16 mg | Brief Pain Inventory (BPI) Average Score at Baseline | Interference item: Sleep | 2.67 Units on a scale | Standard Deviation 4.62 |
| OROS Hydromorphone 16 mg | Brief Pain Inventory (BPI) Average Score at Baseline | Interference item: General activity | 4.33 Units on a scale | Standard Deviation 3.79 |
| OROS Hydromorphone 16 mg | Brief Pain Inventory (BPI) Average Score at Baseline | Severity item: Pain right now | 2.67 Units on a scale | Standard Deviation 3.06 |
| OROS Hydromorphone 16 mg | Brief Pain Inventory (BPI) Average Score at Baseline | Severity item: Average pain | 3.00 Units on a scale | Standard Deviation 2.65 |
| OROS Hydromorphone 16 mg | Brief Pain Inventory (BPI) Average Score at Baseline | Interference item: Mood | 5.33 Units on a scale | Standard Deviation 4.73 |
| OROS Hydromorphone 16 mg | Brief Pain Inventory (BPI) Average Score at Baseline | Severity item: Least pain in last 24 hours | 1.00 Units on a scale | Standard Deviation 1.73 |
| OROS Hydromorphone 16 mg | Brief Pain Inventory (BPI) Average Score at Baseline | Interference item: Walking ability | 5.33 Units on a scale | Standard Deviation 4.62 |
| OROS Hydromorphone 16 mg | Brief Pain Inventory (BPI) Average Score at Baseline | Severity item: Worst pain in last 24 hours | 4.00 Units on a scale | Standard Deviation 4 |
| OROS Hydromorphone 16 mg | Brief Pain Inventory (BPI) Average Score at Baseline | Interference item: Normal work | 6.33 Units on a scale | Standard Deviation 5.51 |
| OROS Hydromorphone 16 mg | Brief Pain Inventory (BPI) Average Score at Baseline | Interference item: Enjoyment of life | 5.00 Units on a scale | Standard Deviation 4.36 |
| OROS Hydromorphone 20 mg | Brief Pain Inventory (BPI) Average Score at Baseline | Interference item: Enjoyment of life | 7.50 Units on a scale | Standard Deviation 0.71 |
| OROS Hydromorphone 20 mg | Brief Pain Inventory (BPI) Average Score at Baseline | Interference item: Walking ability | 8.00 Units on a scale | Standard Deviation 2.83 |
| OROS Hydromorphone 20 mg | Brief Pain Inventory (BPI) Average Score at Baseline | Interference item: General activity | 6.50 Units on a scale | Standard Deviation 2.12 |
| OROS Hydromorphone 20 mg | Brief Pain Inventory (BPI) Average Score at Baseline | Interference item: Mood | 6.00 Units on a scale | Standard Deviation 1.41 |
| OROS Hydromorphone 20 mg | Brief Pain Inventory (BPI) Average Score at Baseline | Interference item: Normal work | 9.00 Units on a scale | Standard Deviation 1.41 |
| OROS Hydromorphone 20 mg | Brief Pain Inventory (BPI) Average Score at Baseline | Interference item: Relationships with other people | 6.50 Units on a scale | Standard Deviation 4.95 |
| OROS Hydromorphone 20 mg | Brief Pain Inventory (BPI) Average Score at Baseline | Interference item: Sleep | 8.00 Units on a scale | Standard Deviation 0 |
| OROS Hydromorphone 20 mg | Brief Pain Inventory (BPI) Average Score at Baseline | Severity item: Worst pain in last 24 hours | 10.00 Units on a scale | Standard Deviation 0 |
| OROS Hydromorphone 20 mg | Brief Pain Inventory (BPI) Average Score at Baseline | Severity item: Least pain in last 24 hours | 3.00 Units on a scale | Standard Deviation 1.41 |
| OROS Hydromorphone 20 mg | Brief Pain Inventory (BPI) Average Score at Baseline | Severity item: Average pain | 5.50 Units on a scale | Standard Deviation 0.71 |
| OROS Hydromorphone 20 mg | Brief Pain Inventory (BPI) Average Score at Baseline | Severity item: Pain right now | 7.00 Units on a scale | Standard Deviation 4.24 |
| OROS Hydromorphone 24 mg | Brief Pain Inventory (BPI) Average Score at Baseline | Severity item: Worst pain in last 24 hours | 2.00 Units on a scale | Standard Deviation 0 |
| OROS Hydromorphone 24 mg | Brief Pain Inventory (BPI) Average Score at Baseline | Interference item: Enjoyment of life | 7.00 Units on a scale | Standard Deviation 0 |
| OROS Hydromorphone 24 mg | Brief Pain Inventory (BPI) Average Score at Baseline | Interference item: Mood | 5.00 Units on a scale | Standard Deviation 0 |
| OROS Hydromorphone 24 mg | Brief Pain Inventory (BPI) Average Score at Baseline | Interference item: Relationships with other people | 8.00 Units on a scale | Standard Deviation 0 |
| OROS Hydromorphone 24 mg | Brief Pain Inventory (BPI) Average Score at Baseline | Severity item: Least pain in last 24 hours | 0.00 Units on a scale | Standard Deviation 0 |
| OROS Hydromorphone 24 mg | Brief Pain Inventory (BPI) Average Score at Baseline | Severity item: Pain right now | 4.00 Units on a scale | Standard Deviation 0 |
| OROS Hydromorphone 24 mg | Brief Pain Inventory (BPI) Average Score at Baseline | Interference item: Walking ability | 3.00 Units on a scale | Standard Deviation 0 |
| OROS Hydromorphone 24 mg | Brief Pain Inventory (BPI) Average Score at Baseline | Interference item: Sleep | 0.00 Units on a scale | Standard Deviation 0 |
| OROS Hydromorphone 24 mg | Brief Pain Inventory (BPI) Average Score at Baseline | Interference item: Normal work | 0.00 Units on a scale | Standard Deviation 0 |
| OROS Hydromorphone 24 mg | Brief Pain Inventory (BPI) Average Score at Baseline | Interference item: General activity | 0.00 Units on a scale | Standard Deviation 0 |
| OROS Hydromorphone 24 mg | Brief Pain Inventory (BPI) Average Score at Baseline | Severity item: Average pain | 1.00 Units on a scale | Standard Deviation 0 |
| OROS Hydromorphone 32 mg | Brief Pain Inventory (BPI) Average Score at Baseline | Interference item: Relationships with other people | 9.00 Units on a scale | Standard Deviation 0 |
| OROS Hydromorphone 32 mg | Brief Pain Inventory (BPI) Average Score at Baseline | Interference item: Enjoyment of life | 8.00 Units on a scale | Standard Deviation 0 |
| OROS Hydromorphone 32 mg | Brief Pain Inventory (BPI) Average Score at Baseline | Interference item: Normal work | 9.00 Units on a scale | Standard Deviation 0 |
| OROS Hydromorphone 32 mg | Brief Pain Inventory (BPI) Average Score at Baseline | Severity item: Pain right now | 3.0 Units on a scale | Standard Deviation 0 |
| OROS Hydromorphone 32 mg | Brief Pain Inventory (BPI) Average Score at Baseline | Severity item: Worst pain in last 24 hours | 8.0 Units on a scale | Standard Deviation 0 |
| OROS Hydromorphone 32 mg | Brief Pain Inventory (BPI) Average Score at Baseline | Interference item: Walking ability | 7.00 Units on a scale | Standard Deviation 0 |
| OROS Hydromorphone 32 mg | Brief Pain Inventory (BPI) Average Score at Baseline | Interference item: Mood | 7.00 Units on a scale | Standard Deviation 0 |
| OROS Hydromorphone 32 mg | Brief Pain Inventory (BPI) Average Score at Baseline | Severity item: Least pain in last 24 hours | 3.0 Units on a scale | Standard Deviation 0 |
| OROS Hydromorphone 32 mg | Brief Pain Inventory (BPI) Average Score at Baseline | Interference item: General activity | 8.0 Units on a scale | Standard Deviation 0 |
| OROS Hydromorphone 32 mg | Brief Pain Inventory (BPI) Average Score at Baseline | Severity item: Average pain | 5.0 Units on a scale | Standard Deviation 0 |
| OROS Hydromorphone 32 mg | Brief Pain Inventory (BPI) Average Score at Baseline | Interference item: Sleep | 5.00 Units on a scale | Standard Deviation 0 |
| OROS Hydromorphone 36 mg | Brief Pain Inventory (BPI) Average Score at Baseline | Interference item: Normal work | 9.00 Units on a scale | Standard Deviation 1.41 |
| OROS Hydromorphone 36 mg | Brief Pain Inventory (BPI) Average Score at Baseline | Interference item: Walking ability | 6.50 Units on a scale | Standard Deviation 0.71 |
| OROS Hydromorphone 36 mg | Brief Pain Inventory (BPI) Average Score at Baseline | Interference item: Enjoyment of life | 4.00 Units on a scale | Standard Deviation 5.66 |
| OROS Hydromorphone 36 mg | Brief Pain Inventory (BPI) Average Score at Baseline | Interference item: General activity | 7.0 Units on a scale | Standard Deviation 1.41 |
| OROS Hydromorphone 36 mg | Brief Pain Inventory (BPI) Average Score at Baseline | Interference item: Sleep | 4.50 Units on a scale | Standard Deviation 4.95 |
| OROS Hydromorphone 36 mg | Brief Pain Inventory (BPI) Average Score at Baseline | Severity item: Average pain | 3.5 Units on a scale | Standard Deviation 4.95 |
| OROS Hydromorphone 36 mg | Brief Pain Inventory (BPI) Average Score at Baseline | Interference item: Relationships with other people | 4.50 Units on a scale | Standard Deviation 4.95 |
| OROS Hydromorphone 36 mg | Brief Pain Inventory (BPI) Average Score at Baseline | Interference item: Mood | 6.00 Units on a scale | Standard Deviation 1.41 |
| OROS Hydromorphone 36 mg | Brief Pain Inventory (BPI) Average Score at Baseline | Severity item: Pain right now | 5.0 Units on a scale | Standard Deviation 4.24 |
| OROS Hydromorphone 36 mg | Brief Pain Inventory (BPI) Average Score at Baseline | Severity item: Least pain in last 24 hours | 3.5 Units on a scale | Standard Deviation 4.95 |
| OROS Hydromorphone 36 mg | Brief Pain Inventory (BPI) Average Score at Baseline | Severity item: Worst pain in last 24 hours | 5.0 Units on a scale | Standard Deviation 2.83 |
Primary
Brief Pain Inventory (BPI) Average Score at Day 28
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.
Time frame: Day 28
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| OROS Hydromorphone 8 Milligram (mg) | Brief Pain Inventory (BPI) Average Score at Day 28 | Interference item: General activity | 2.00 Units on a scale | Standard Deviation 0 |
| OROS Hydromorphone 8 Milligram (mg) | 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 |
| OROS Hydromorphone 8 Milligram (mg) | Brief Pain Inventory (BPI) Average Score at Day 28 | Interference item: Sleep | 1.00 Units on a scale | Standard Deviation 0 |
| OROS Hydromorphone 8 Milligram (mg) | 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 |
| OROS Hydromorphone 8 Milligram (mg) | Brief Pain Inventory (BPI) Average Score at Day 28 | Interference item: Enjoyment of life | 1.00 Units on a scale | Standard Deviation 0 |
| OROS Hydromorphone 8 Milligram (mg) | Brief Pain Inventory (BPI) Average Score at Day 28 | Severity item: Average pain | 2.00 Units on a scale | Standard Deviation 0 |
| OROS Hydromorphone 8 Milligram (mg) | Brief Pain Inventory (BPI) Average Score at Day 28 | Interference item: Relationships with other people | 1.00 Units on a scale | Standard Deviation 0 |
| OROS Hydromorphone 8 Milligram (mg) | Brief Pain Inventory (BPI) Average Score at Day 28 | Severity item: Pain right now | 2.00 Units on a scale | Standard Deviation 0 |
| OROS Hydromorphone 8 Milligram (mg) | Brief Pain Inventory (BPI) Average Score at Day 28 | Interference item: Normal work | 2.00 Units on a scale | Standard Deviation 0 |
| OROS Hydromorphone 8 Milligram (mg) | Brief Pain Inventory (BPI) Average Score at Day 28 | Interference item: Talking ability | 0.00 Units on a scale | Standard Deviation 0 |
| OROS Hydromorphone 8 Milligram (mg) | Brief Pain Inventory (BPI) Average Score at Day 28 | Interference item: Mood | 2.00 Units on a scale | Standard Deviation 0 |
| OROS Hydromorphone 12 mg | Brief Pain Inventory (BPI) Average Score at Day 28 | Severity item: Least pain in last 24 hours | 2.40 Units on a scale | Standard Deviation 3.05 |
| OROS Hydromorphone 12 mg | Brief Pain Inventory (BPI) Average Score at Day 28 | Interference item: General activity | 4.20 Units on a scale | Standard Deviation 4.6 |
| OROS Hydromorphone 12 mg | Brief Pain Inventory (BPI) Average Score at Day 28 | Interference item: Talking ability | 4.00 Units on a scale | Standard Deviation 4.69 |
| OROS Hydromorphone 12 mg | Brief Pain Inventory (BPI) Average Score at Day 28 | Interference item: Sleep | 2.60 Units on a scale | Standard Deviation 3.44 |
| OROS Hydromorphone 12 mg | Brief Pain Inventory (BPI) Average Score at Day 28 | Interference item: Relationships with other people | 1.80 Units on a scale | Standard Deviation 3.49 |
| OROS Hydromorphone 12 mg | Brief Pain Inventory (BPI) Average Score at Day 28 | Severity item: Worst pain in last 24 hours | 3.20 Units on a scale | Standard Deviation 3.35 |
| OROS Hydromorphone 12 mg | Brief Pain Inventory (BPI) Average Score at Day 28 | Severity item: Pain right now | 1.00 Units on a scale | Standard Deviation 2.24 |
| OROS Hydromorphone 12 mg | Brief Pain Inventory (BPI) Average Score at Day 28 | Interference item: Enjoyment of life | 1.20 Units on a scale | Standard Deviation 2.17 |
| OROS Hydromorphone 12 mg | Brief Pain Inventory (BPI) Average Score at Day 28 | Interference item: Normal work | 3.20 Units on a scale | Standard Deviation 4.32 |
| OROS Hydromorphone 12 mg | Brief Pain Inventory (BPI) Average Score at Day 28 | Interference item: Mood | 1.80 Units on a scale | Standard Deviation 3.03 |
| OROS Hydromorphone 12 mg | Brief Pain Inventory (BPI) Average Score at Day 28 | Severity item: Average pain | 2.40 Units on a scale | Standard Deviation 3.21 |
| OROS Hydromorphone 16 mg | Brief Pain Inventory (BPI) Average Score at Day 28 | Severity item: Pain right now | 0.00 Units on a scale | Standard Deviation 0 |
| OROS Hydromorphone 16 mg | Brief Pain Inventory (BPI) Average Score at Day 28 | Severity item: Average pain | 0.00 Units on a scale | Standard Deviation 0 |
| OROS Hydromorphone 16 mg | Brief Pain Inventory (BPI) Average Score at Day 28 | Interference item: General activity | 0.00 Units on a scale | Standard Deviation 0 |
| OROS Hydromorphone 16 mg | Brief Pain Inventory (BPI) Average Score at Day 28 | Interference item: Mood | 0.00 Units on a scale | Standard Deviation 0 |
| OROS Hydromorphone 16 mg | Brief Pain Inventory (BPI) Average Score at Day 28 | Interference item: Talking ability | 0.00 Units on a scale | Standard Deviation 0 |
| OROS Hydromorphone 16 mg | Brief Pain Inventory (BPI) Average Score at Day 28 | Interference item: Normal work | 0.00 Units on a scale | Standard Deviation 0 |
| OROS Hydromorphone 16 mg | Brief Pain Inventory (BPI) Average Score at Day 28 | Interference item: Relationships with other people | 0.00 Units on a scale | Standard Deviation 0 |
| OROS Hydromorphone 16 mg | Brief Pain Inventory (BPI) Average Score at Day 28 | Interference item: Sleep | 0.00 Units on a scale | Standard Deviation 0 |
| OROS Hydromorphone 16 mg | Brief Pain Inventory (BPI) Average Score at Day 28 | Interference item: Enjoyment of life | 0.00 Units on a scale | Standard Deviation 0 |
| OROS Hydromorphone 16 mg | Brief Pain Inventory (BPI) Average Score at Day 28 | Severity item: Worst pain in last 24 hours | 0.00 Units on a scale | Standard Deviation 0 |
| OROS Hydromorphone 16 mg | 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 |
| OROS Hydromorphone 20 mg | Brief Pain Inventory (BPI) Average Score at Day 28 | Interference item: General activity | 5.00 Units on a scale | Standard Deviation 7.07 |
| OROS Hydromorphone 20 mg | Brief Pain Inventory (BPI) Average Score at Day 28 | Interference item: Normal work | 5.00 Units on a scale | Standard Deviation 7.07 |
| OROS Hydromorphone 20 mg | Brief Pain Inventory (BPI) Average Score at Day 28 | Severity item: Pain right now | 0.00 Units on a scale | Standard Deviation 0 |
| OROS Hydromorphone 20 mg | Brief Pain Inventory (BPI) Average Score at Day 28 | Interference item: Relationships with other people | 5.00 Units on a scale | Standard Deviation 7.07 |
| OROS Hydromorphone 20 mg | Brief Pain Inventory (BPI) Average Score at Day 28 | Severity item: Worst pain in last 24 hours | 4.00 Units on a scale | Standard Deviation 5.66 |
| OROS Hydromorphone 20 mg | Brief Pain Inventory (BPI) Average Score at Day 28 | Interference item: Talking ability | 5.00 Units on a scale | Standard Deviation 7.07 |
| OROS Hydromorphone 20 mg | Brief Pain Inventory (BPI) Average Score at Day 28 | Interference item: Mood | 5.00 Units on a scale | Standard Deviation 7.07 |
| OROS Hydromorphone 20 mg | Brief Pain Inventory (BPI) Average Score at Day 28 | Interference item: Enjoyment of life | 4.00 Units on a scale | Standard Deviation 5.66 |
| OROS Hydromorphone 20 mg | Brief Pain Inventory (BPI) Average Score at Day 28 | Interference item: Sleep | 2.00 Units on a scale | Standard Deviation 2.83 |
| OROS Hydromorphone 20 mg | Brief Pain Inventory (BPI) Average Score at Day 28 | Severity item: Least pain in last 24 hours | 1.50 Units on a scale | Standard Deviation 2.12 |
| OROS Hydromorphone 20 mg | Brief Pain Inventory (BPI) Average Score at Day 28 | Severity item: Average pain | 1.50 Units on a scale | Standard Deviation 2.12 |
| OROS Hydromorphone 24 mg | Brief Pain Inventory (BPI) Average Score at Day 28 | Interference item: Mood | 0.00 Units on a scale | Standard Deviation 0 |
| OROS Hydromorphone 24 mg | Brief Pain Inventory (BPI) Average Score at Day 28 | Interference item: Talking ability | 0.00 Units on a scale | Standard Deviation 0 |
| OROS Hydromorphone 24 mg | Brief Pain Inventory (BPI) Average Score at Day 28 | Severity item: Worst pain in last 24 hours | 4.00 Units on a scale | Standard Deviation 0 |
| OROS Hydromorphone 24 mg | Brief Pain Inventory (BPI) Average Score at Day 28 | Interference item: Normal work | 0.00 Units on a scale | Standard Deviation 0 |
| OROS Hydromorphone 24 mg | Brief Pain Inventory (BPI) Average Score at Day 28 | Severity item: Average pain | 0.00 Units on a scale | Standard Deviation 0 |
| OROS Hydromorphone 24 mg | Brief Pain Inventory (BPI) Average Score at Day 28 | Interference item: Relationships with other people | 0.00 Units on a scale | Standard Deviation 0 |
| OROS Hydromorphone 24 mg | Brief Pain Inventory (BPI) Average Score at Day 28 | Interference item: Sleep | 0.00 Units on a scale | Standard Deviation 0 |
| OROS Hydromorphone 24 mg | Brief Pain Inventory (BPI) Average Score at Day 28 | Interference item: Enjoyment of life | 0.00 Units on a scale | Standard Deviation 0 |
| OROS Hydromorphone 24 mg | 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 |
| OROS Hydromorphone 24 mg | Brief Pain Inventory (BPI) Average Score at Day 28 | Interference item: General activity | 0.00 Units on a scale | Standard Deviation 0 |
| OROS Hydromorphone 24 mg | Brief Pain Inventory (BPI) Average Score at Day 28 | Severity item: Pain right now | 0.00 Units on a scale | Standard Deviation 0 |
| OROS Hydromorphone 32 mg | Brief Pain Inventory (BPI) Average Score at Day 28 | Interference item: Sleep | 7.33 Units on a scale | Standard Deviation 3.06 |
| OROS Hydromorphone 32 mg | Brief Pain Inventory (BPI) Average Score at Day 28 | Interference item: Mood | 4.67 Units on a scale | Standard Deviation 2.89 |
| OROS Hydromorphone 32 mg | Brief Pain Inventory (BPI) Average Score at Day 28 | Interference item: Talking ability | 8.00 Units on a scale | Standard Deviation 3.46 |
| OROS Hydromorphone 32 mg | Brief Pain Inventory (BPI) Average Score at Day 28 | Severity item: Least pain in last 24 hours | 3.67 Units on a scale | Standard Deviation 4.04 |
| OROS Hydromorphone 32 mg | Brief Pain Inventory (BPI) Average Score at Day 28 | Interference item: Enjoyment of life | 5.33 Units on a scale | Standard Deviation 4.04 |
| OROS Hydromorphone 32 mg | Brief Pain Inventory (BPI) Average Score at Day 28 | Severity item: Average pain | 5.33 Units on a scale | Standard Deviation 3.06 |
| OROS Hydromorphone 32 mg | Brief Pain Inventory (BPI) Average Score at Day 28 | Severity item: Pain right now | 6.67 Units on a scale | Standard Deviation 4.04 |
| OROS Hydromorphone 32 mg | Brief Pain Inventory (BPI) Average Score at Day 28 | Severity item: Worst pain in last 24 hours | 7.00 Units on a scale | Standard Deviation 3.61 |
| OROS Hydromorphone 32 mg | Brief Pain Inventory (BPI) Average Score at Day 28 | Interference item: Normal work | 8.00 Units on a scale | Standard Deviation 3.46 |
| OROS Hydromorphone 32 mg | Brief Pain Inventory (BPI) Average Score at Day 28 | Interference item: General activity | 7.33 Units on a scale | Standard Deviation 4.62 |
| OROS Hydromorphone 32 mg | Brief Pain Inventory (BPI) Average Score at Day 28 | Interference item: Relationships with other people | 5.00 Units on a scale | Standard Deviation 4.58 |
| OROS Hydromorphone 36 mg | Brief Pain Inventory (BPI) Average Score at Day 28 | Interference item: Enjoyment of life | 5.00 Units on a scale | Standard Deviation 0 |
| OROS Hydromorphone 36 mg | Brief Pain Inventory (BPI) Average Score at Day 28 | Severity item: Worst pain in last 24 hours | 7.00 Units on a scale | Standard Deviation 0 |
| OROS Hydromorphone 36 mg | Brief Pain Inventory (BPI) Average Score at Day 28 | Interference item: Talking ability | 7.00 Units on a scale | Standard Deviation 0 |
| OROS Hydromorphone 36 mg | Brief Pain Inventory (BPI) Average Score at Day 28 | Interference item: General activity | 7.00 Units on a scale | Standard Deviation 0 |
| OROS Hydromorphone 36 mg | Brief Pain Inventory (BPI) Average Score at Day 28 | Severity item: Least pain in last 24 hours | 3.00 Units on a scale | Standard Deviation 0 |
| OROS Hydromorphone 36 mg | Brief Pain Inventory (BPI) Average Score at Day 28 | Interference item: Relationships with other people | 5.00 Units on a scale | Standard Deviation 0 |
| OROS Hydromorphone 36 mg | Brief Pain Inventory (BPI) Average Score at Day 28 | Severity item: Pain right now | 3.00 Units on a scale | Standard Deviation 0 |
| OROS Hydromorphone 36 mg | Brief Pain Inventory (BPI) Average Score at Day 28 | Severity item: Average pain | 4.00 Units on a scale | Standard Deviation 0 |
| OROS Hydromorphone 36 mg | Brief Pain Inventory (BPI) Average Score at Day 28 | Interference item: Sleep | 5.00 Units on a scale | Standard Deviation 0 |
| OROS Hydromorphone 36 mg | Brief Pain Inventory (BPI) Average Score at Day 28 | Interference item: Mood | 7.00 Units on a scale | Standard Deviation 0 |
| OROS Hydromorphone 36 mg | Brief Pain Inventory (BPI) Average Score at Day 28 | Interference item: Normal work | 7.00 Units on a scale | Standard Deviation 0 |
Secondary
Number of Participants Given Rescue Pain Medications
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.
Time frame: Day 28
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| OROS Hydromorphone 8 Milligram (mg) | Number of Participants Given Rescue Pain Medications | 1 Participants |
| OROS Hydromorphone 12 mg | Number of Participants Given Rescue Pain Medications | 4 Participants |
| OROS Hydromorphone 16 mg | Number of Participants Given Rescue Pain Medications | 0 Participants |
| OROS Hydromorphone 20 mg | Number of Participants Given Rescue Pain Medications | 1 Participants |
| OROS Hydromorphone 24 mg | Number of Participants Given Rescue Pain Medications | 1 Participants |
| OROS Hydromorphone 32 mg | Number of Participants Given Rescue Pain Medications | 2 Participants |
| OROS Hydromorphone 36 mg | Number of Participants Given Rescue Pain Medications | 1 Participants |
| OROS Hydromorphone (No Dose Indicated) | Number of Participants Given Rescue Pain Medications | 2 Participants |
Secondary
Number of Participants With Categorical Score on Clinical Global Impression Scale as Assessed by Clinician
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).
Time frame: Day 28
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| OROS Hydromorphone 8 Milligram (mg) | Number of Participants With Categorical Score on Clinical Global Impression Scale as Assessed by Clinician | Minimally worse: Day 28 (n=15) | 0 Participants |
| OROS Hydromorphone 8 Milligram (mg) | Number of Participants With Categorical Score on Clinical Global Impression Scale as Assessed by Clinician | Very much worse: Day 28 (n=15) | 0 Participants |
| OROS Hydromorphone 8 Milligram (mg) | Number of Participants With Categorical Score on Clinical Global Impression Scale as Assessed by Clinician | No change: Day 28 (n=15) | 1 Participants |
| OROS Hydromorphone 8 Milligram (mg) | Number of Participants With Categorical Score on Clinical Global Impression Scale as Assessed by Clinician | Very much improved: Day 28 (n=15) | 7 Participants |
| OROS Hydromorphone 8 Milligram (mg) | Number of Participants With Categorical Score on Clinical Global Impression Scale as Assessed by Clinician | Much improved: Day 28 (n=15) | 3 Participants |
| OROS Hydromorphone 8 Milligram (mg) | Number of Participants With Categorical Score on Clinical Global Impression Scale as Assessed by Clinician | Minimally improved: Day 28 (n=15) | 3 Participants |
| OROS Hydromorphone 8 Milligram (mg) | Number of Participants With Categorical Score on Clinical Global Impression Scale as Assessed by Clinician | Not evaluated: Day 28 (n=15) | 1 Participants |