Safety and Efficacy Study of Osmotic Release Oral System (OROS) Hydromorphone in Participants With Cancer Pain
Primary Purpose
Pain
Status
Terminated
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Osmotic Release Oral System (OROS) hydromorphone
Sponsored by
About this trial
This is an interventional treatment trial for Pain focused on measuring Pain, Cancer, Osmotic Release Oral System, OROS Hydromorphone, Jurnista
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Osmotic Release Oral System (OROS) Hydromorphone
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01648699
Brief Title
Safety and Efficacy Study of Osmotic Release Oral System (OROS) Hydromorphone in Participants With Cancer Pain
Official Title
Study on the Effectiveness and Safety of OROS Hydromorphone in Pain Management Among Patients With Cancer Pain
Study Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Terminated
Why Stopped
the study was stopped due to non-availability of 4mg
Study Start Date
April 2010 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Pharmaceutica
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
Keywords
Pain, Cancer, Osmotic Release Oral System, OROS Hydromorphone, Jurnista
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Osmotic Release Oral System (OROS) Hydromorphone
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Osmotic Release Oral System (OROS) hydromorphone
Other Intervention Name(s)
Jumista
Intervention Description
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.
Primary Outcome Measure Information:
Title
Brief Pain Inventory (BPI) Average Score at Baseline
Description
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
Title
Brief Pain Inventory (BPI) Average Score at Day 28
Description
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
Secondary Outcome Measure Information:
Title
Number of Participants Given Rescue Pain Medications
Description
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
Title
Number of Participants With Categorical Score on Clinical Global Impression Scale as Assessed by Clinician
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Pharmaceutica Clinical Trial
Organizational Affiliation
Janssen Pharmaceutica
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy Study of Osmotic Release Oral System (OROS) Hydromorphone in Participants With Cancer Pain
We'll reach out to this number within 24 hrs