- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01648699
Safety and Efficacy Study of Osmotic Release Oral System (OROS) Hydromorphone in Participants With Cancer Pain
October 1, 2013 updated by: Janssen Pharmaceutica
Study on the Effectiveness and Safety of OROS Hydromorphone in Pain Management Among Patients With Cancer Pain
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Osmotic 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.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Brief Pain Inventory (BPI) Average Score at Baseline
Time Frame: 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.
|
Baseline
|
Brief Pain Inventory (BPI) Average Score at Day 28
Time Frame: 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.
|
Day 28
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants Given Rescue Pain Medications
Time Frame: 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.
|
Day 28
|
Number of Participants With Categorical Score on Clinical Global Impression Scale as Assessed by Clinician
Time Frame: 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).
|
Day 28
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2010
Primary Completion (Actual)
September 1, 2010
Study Completion (Actual)
September 1, 2010
Study Registration Dates
First Submitted
July 20, 2012
First Submitted That Met QC Criteria
July 20, 2012
First Posted (Estimate)
July 24, 2012
Study Record Updates
Last Update Posted (Estimate)
October 11, 2013
Last Update Submitted That Met QC Criteria
October 1, 2013
Last Verified
October 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR016351
- 42801PAI4008
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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