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A Double-blind Study of Controlled Release OROS Hydromorphone Compared to Placebo in Patients With Chronic Osteoarthritis (OA) Pain

Primary Purpose

Chronic Pain

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
OROS hydromorphone
Placebo
Sponsored by
Mallinckrodt
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring OA, Chronic Pain, Osteoarthritis, OA Pain, Osteoarthritis Pain, Pain, Hip Pain, Knee Pain, Joint Pain

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria

  • Primary clinic diagnosis of osteoarthritis pain of the hip or of the knee for at least 6 months
  • Patients required daily opioid medication to treat their chronic osteoarthritis pain

Exclusion Criteria

  • Joint replacement of the hip or of the knee that is the primary source of osteoarthritis Pain
  • History drug or alcohol abuse
  • Fibromyalgia
  • Patients who have major depression or anxiety
  • Women who are pregnant or breast feeding

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    OROS Hydromorphone

    Placebo

    Arm Description

    OROS hydromorphone tablets administered orally once daily in total daily doses of 12, 16, 24, 32, 40, 48, or 64 mg

    Matching placebo tablets orally once daily (number and dosage of tablets to match the number and dosage of the stable dose of OROS hydromorphone obtained in the Conversion and Titration phase).

    Outcomes

    Primary Outcome Measures

    Patient Diary-derived Numeric Rating Scale (NRS) Pain Intensity Change From Baseline to Week 12 or Final Visit of the Double-blind Phase
    Participants rate their pain intensity on a numeric rating scale (NRS), where 0=no pain and 10=worst possible pain, in a daily diary. At Week 12 (or final visit), all measurements during the preceding week are averaged, and the mean change from the mean score at baseline is calculated.

    Secondary Outcome Measures

    Full Information

    First Posted
    February 28, 2008
    Last Updated
    August 27, 2020
    Sponsor
    Mallinckrodt
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00631319
    Brief Title
    A Double-blind Study of Controlled Release OROS Hydromorphone Compared to Placebo in Patients With Chronic Osteoarthritis (OA) Pain
    Official Title
    A Phase III, Flexible Dose Titration Followed by a Randomized Double-Blind Study of Controlled Release OROS Hydromorphone HCL Compared to Placebo in Patients With OA Pain
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2008 (undefined)
    Primary Completion Date
    April 2009 (Actual)
    Study Completion Date
    June 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Mallinckrodt

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    To evaluate the efficacy of OROS Hydromorphone in reducing moderate to severe chronic pain in patients with Osteoarthritis (OA) Pain

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Pain
    Keywords
    OA, Chronic Pain, Osteoarthritis, OA Pain, Osteoarthritis Pain, Pain, Hip Pain, Knee Pain, Joint Pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    343 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    OROS Hydromorphone
    Arm Type
    Experimental
    Arm Description
    OROS hydromorphone tablets administered orally once daily in total daily doses of 12, 16, 24, 32, 40, 48, or 64 mg
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Matching placebo tablets orally once daily (number and dosage of tablets to match the number and dosage of the stable dose of OROS hydromorphone obtained in the Conversion and Titration phase).
    Intervention Type
    Drug
    Intervention Name(s)
    OROS hydromorphone
    Intervention Description
    hydromorphone 12, 16, 24, 32, 40, 48, or 64 mg tablets
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo
    Primary Outcome Measure Information:
    Title
    Patient Diary-derived Numeric Rating Scale (NRS) Pain Intensity Change From Baseline to Week 12 or Final Visit of the Double-blind Phase
    Description
    Participants rate their pain intensity on a numeric rating scale (NRS), where 0=no pain and 10=worst possible pain, in a daily diary. At Week 12 (or final visit), all measurements during the preceding week are averaged, and the mean change from the mean score at baseline is calculated.
    Time Frame
    Baseline, Week 12
    Other Pre-specified Outcome Measures:
    Title
    Patient Diary-derived Numeric Rating Scale (NRS) Pain Intensity and Change From Baseline by Visit in the Double-blind Phase
    Time Frame
    Baseline to Week 12
    Title
    Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score and Change From Baseline by Visit in the Double-blind Phase
    Time Frame
    Baseline to Week 12
    Title
    Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score and Change From Baseline by Visit in the Double-blind Phase
    Time Frame
    Baseline to Week 12
    Title
    Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score and Change From Baseline by Visit in the Double-blind Phase
    Time Frame
    Baseline to Week 12
    Title
    Patient Global Assessment and Change From Baseline by Visit in the Double-blind Phase
    Time Frame
    Baseline to Week 12
    Title
    Time to Treatment Failure From Baseline
    Time Frame
    within 12 weeks from Baseline

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria Primary clinic diagnosis of osteoarthritis pain of the hip or of the knee for at least 6 months Patients required daily opioid medication to treat their chronic osteoarthritis pain Exclusion Criteria Joint replacement of the hip or of the knee that is the primary source of osteoarthritis Pain History drug or alcohol abuse Fibromyalgia Patients who have major depression or anxiety Women who are pregnant or breast feeding

    12. IPD Sharing Statement

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    A Double-blind Study of Controlled Release OROS Hydromorphone Compared to Placebo in Patients With Chronic Osteoarthritis (OA) Pain

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