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Safety, Effectiveness, and Impact on Quality of Life on Long-Term Administration of OROS Hydromorphone Slow-Release in Patients With Chronic Low Back Pain

Primary Purpose

Low Back Pain

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
OROS hydromorphone HCI SR (slow release)
Sponsored by
Alza Corporation, DE, USA
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Chronic low back pain, OROS hydromorphone slow release tablet, Quality of Life

Eligibility Criteria

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

Inclusion Criteria:

  • Patients who have chronic low back pain who have successfully completed short-term Study DO-127 with OROS hydromorphone slow release
  • Patients who require at least 8 mg of hydromorphone HCI (slow release) every 24 hours for the management of chronic low back pain
  • Patients whose opioid requirements have been stable as demonstrated in short-term Study DO-127 with OROS hydromorphone slow release

Exclusion Criteria:

  • Patients intolerant of or hypersensitive to hydromorphone (or other opioid agonists)
  • Patients who are pregnant or breast-feeding
  • Patients with any gastrointestinal disorder, including pre-existing severe GI narrowing (pathologic or iatrogenic) that may affect the absorption or transit of orally administered drugs
  • Patients with significant CNS disorder, including but not limited to head injury, intracranial lesion, increased intracranial pressure, seizure disorder, stroke within the past 6 months, disorders of cognition, any clinically significant impaired renal or hepatic function, Addison's disease, hypothyroidism, prostatic hypertrophy, or urethral stricture
  • Patients who may be at risk for serious decreases in blood pressure upon taking an opioid analgesic

Sites / Locations

    Outcomes

    Primary Outcome Measures

    The daily pain relief rating obtained during the study.(six months)

    Secondary Outcome Measures

    Differences from first visit to each subsequent visit in Brief Pain Inventory (BPI) ratings, sleep scores and quality of life questionnaires.

    Full Information

    First Posted
    December 12, 2006
    Last Updated
    April 26, 2010
    Sponsor
    Alza Corporation, DE, USA
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00411268
    Brief Title
    Safety, Effectiveness, and Impact on Quality of Life on Long-Term Administration of OROS Hydromorphone Slow-Release in Patients With Chronic Low Back Pain
    Official Title
    Safety, Efficacy and Impact on Quality of Life of Long-Term Administration of Dilaudid CR (Hydromorphone HCI) in Patients With Chronic Low Back Pain
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2010
    Overall Recruitment Status
    Completed
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    June 2001 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Alza Corporation, DE, USA

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this open-label, extension study is to characterize the safety, effectiveness, and impact on quality of life measures of long-term repeated dosing of OROS hydromorphone slow release (8, 16, 32 and 64 mg tablets) in patients with chronic low back pain.
    Detailed Description
    This open label, extension study characterized the safety, effectiveness, and impact on quality of life of OROS hydromorphone slow release with long-term repeated dosing among patients with chronic low back pain, who previously completed short-term Study DO-127 with OROS hydromorphone slow release. Up to 150 patients were to be enrolled and evaluated. Patients were enrolled in this study immediately following Study DO-127. Patients continued their therapy with OROS hydromorphone slow release at the stable dose previously identified in the short-term study. The patient's initial prescribed dose of OROS hydromorphone slow release in Study DO-127X was the same as the last dose of OROS hydromorphone slow release in Study DO-127. Patients returned monthly for evaluations during this extension interval. Adjustments to dose were performed as needed, at the Investigator's discretion. The duration of this study was six months. Safety assessments included vital signs and physical examination at start, during and end of study. 8, 16, 32 and 64 mg tablets of OROS hydromorphone (dose will be at Investigators' discretion) slow release tablets were taken orally daily for the duration of the six month study

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Low Back Pain
    Keywords
    Chronic low back pain, OROS hydromorphone slow release tablet, Quality of Life

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    207 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    OROS hydromorphone HCI SR (slow release)
    Primary Outcome Measure Information:
    Title
    The daily pain relief rating obtained during the study.(six months)
    Secondary Outcome Measure Information:
    Title
    Differences from first visit to each subsequent visit in Brief Pain Inventory (BPI) ratings, sleep scores and quality of life questionnaires.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients who have chronic low back pain who have successfully completed short-term Study DO-127 with OROS hydromorphone slow release Patients who require at least 8 mg of hydromorphone HCI (slow release) every 24 hours for the management of chronic low back pain Patients whose opioid requirements have been stable as demonstrated in short-term Study DO-127 with OROS hydromorphone slow release Exclusion Criteria: Patients intolerant of or hypersensitive to hydromorphone (or other opioid agonists) Patients who are pregnant or breast-feeding Patients with any gastrointestinal disorder, including pre-existing severe GI narrowing (pathologic or iatrogenic) that may affect the absorption or transit of orally administered drugs Patients with significant CNS disorder, including but not limited to head injury, intracranial lesion, increased intracranial pressure, seizure disorder, stroke within the past 6 months, disorders of cognition, any clinically significant impaired renal or hepatic function, Addison's disease, hypothyroidism, prostatic hypertrophy, or urethral stricture Patients who may be at risk for serious decreases in blood pressure upon taking an opioid analgesic
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Alza Corporation Clinical Trial
    Organizational Affiliation
    ALZA
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Safety, Effectiveness, and Impact on Quality of Life on Long-Term Administration of OROS Hydromorphone Slow-Release in Patients With Chronic Low Back Pain

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