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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
Janssen Pharmaceutica
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    July 20, 2012
    Last Updated
    October 1, 2013
    Sponsor
    Janssen Pharmaceutica
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    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

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