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A Randomized, Open-Label, Single-Dose, Small Study to Evaluate the Safety and Effectiveness of Hydromorphone in Patients With Short Term, Moderate to Severe Postoperative Pain

Primary Purpose

Pain, Postoperative, Orthopedic Procedures, Analgesia

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
OROS hydromorphone HCI
Sponsored by
Alza Corporation, DE, USA
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative focused on measuring Analgesia, Postoperative pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients undergoing primary, unilateral total knee replacement surgery where use of opioid analgesics for short-term postoperative pain is required
  • At baseline must be able to tolerate oral liquids, swallow a tablet, and have the presence of bowel sounds upon examination
  • Patients must demonstrate stable vital signs immediately before dosing with OROS hydromorphone HCI
  • At baseline pain intensity upon movement must be scored by the patient as 2 or 3 (moderate or severe) on the Pain Intensity Rating Scale
  • At baseline patients receiving regional anesthetics/analgesics must demonstrate recovery from the motor and sensory effects of the nerve blockade
  • Patients must be administered OROS hydromorphone HCI between 6 and 48 hours following completion of surgery
  • Patients should expect to remain hospitalized for 36 hours after study drug administration.

Exclusion Criteria:

  • Patients either intolerant of hydromorphone or who have experienced an anaphylactic IgE-mediated immune response (e.g. hives, wheezing, angioedema or bronchospasms) to any opioid agonist
  • Patients having previously undergone the following major surgery for high tibial osteotomy, knee arthroplasty to the affected knee
  • 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 who are pregnant or breast-feeding. A negative pregnancy test is required prior to administration of the study medication in females of childbearing potential
  • 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, and disorders of cognition
  • Patients with clinically significant impaired renal, hepatic, or hematological function
  • adrenocortical insufficiency
  • uncontrolled hypothyroidism or hyperthyroidism, or clinically significant urinary obstruction

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Variables measured included: Total number of doses/amount of rescue medication hydromorphone (immediate release) taken for breakthrough pain during 36 hours post OROS hydromorphone (slow release) administration

    Secondary Outcome Measures

    Variables measured included:Pain relief scores; Pain intensity scores;Patient's rating of sleep interference;global evaluation of analgesia; oxygen saturation; vital signs and adverse events

    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
    NCT00411307
    Brief Title
    A Randomized, Open-Label, Single-Dose, Small Study to Evaluate the Safety and Effectiveness of Hydromorphone in Patients With Short Term, Moderate to Severe Postoperative Pain
    Official Title
    A Randomized, Open-Label, Single-Dose, Pilot Study to Evaluate the Safety and Efficacy of OROS Hydromorphone in Patients With Acute, Moderate-to-Severe Postoperative 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
    October 2001 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Alza Corporation, DE, USA

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this small study was to investigate the safety and effectiveness of OROS hydromorphone HCI for the treatment of short-term, moderate to severe postoperative pain following total knee replacement surgery.
    Detailed Description
    This was a multicenter, randomized (patients are assigned different treatments based on chance), open-label, single dose small study. During the 36 hour study period, concomitant analgesic (pain) medications and physical therapy were recorded in the patient's case report form. The study duration for each patient was 36 hours after a single dose of OROS hydromorphone HCI had been administered. After surgery, eligible patients had to tolerate liquids, swallow a tablet, and have audible bowel sounds. Before OROS hydromorphone HCI was administered, all analgesic medications were discontinued and patients with a pain score of 2(moderate pain) or 3 (severe pain) upon movement were eligible to enter the study and receive a single oral dose of OROS hydromorphone HCI. Patients had to have stable heart rates, blood pressure, respiration, oxygen saturation greater than or equal to 94% and patients who had undergone regional anesthesia had to have motor and sensory recovery from nerve blockade. Qualifying patients were given OROS hydromorphone HCI between 6 and 48 hours after completion of the surgical procedure. Patients were randomized into 3 groups (OROS hydromorphone HCI 8, 16, and 32 mg). The precise time of OROS hydromorphone HCI administration was considered time zero. To maintain consistency, dosing was to occur between 6 am and 2 pm, if possible. Following study drug administration, patients could be given rescue medication of oral hydromorphone immediate-release tablets (2 or 4 mg) for breakthrough pain as needed. Oxygen saturation, vital signs, pain relief ratings, and pain intensity ratings at rest and upon movement were obtained at 2-hour time intervals during the first 8 hours following study drug administration, and at 4 hour intervals from 8 to 36 hours following study drug administration. The study concluded 36 hours after dosing, at which time a global evaluation of pain relief was obtained from each patient. One single dose of OROS hydromorphone HCI (8, 16, or 32 mg) administered orally at the beginning of the 36 hour study.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pain, Postoperative, Orthopedic Procedures, Analgesia
    Keywords
    Analgesia, Postoperative pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    50 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    OROS hydromorphone HCI
    Primary Outcome Measure Information:
    Title
    Variables measured included: Total number of doses/amount of rescue medication hydromorphone (immediate release) taken for breakthrough pain during 36 hours post OROS hydromorphone (slow release) administration
    Secondary Outcome Measure Information:
    Title
    Variables measured included:Pain relief scores; Pain intensity scores;Patient's rating of sleep interference;global evaluation of analgesia; oxygen saturation; vital signs and adverse events

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients undergoing primary, unilateral total knee replacement surgery where use of opioid analgesics for short-term postoperative pain is required At baseline must be able to tolerate oral liquids, swallow a tablet, and have the presence of bowel sounds upon examination Patients must demonstrate stable vital signs immediately before dosing with OROS hydromorphone HCI At baseline pain intensity upon movement must be scored by the patient as 2 or 3 (moderate or severe) on the Pain Intensity Rating Scale At baseline patients receiving regional anesthetics/analgesics must demonstrate recovery from the motor and sensory effects of the nerve blockade Patients must be administered OROS hydromorphone HCI between 6 and 48 hours following completion of surgery Patients should expect to remain hospitalized for 36 hours after study drug administration. Exclusion Criteria: Patients either intolerant of hydromorphone or who have experienced an anaphylactic IgE-mediated immune response (e.g. hives, wheezing, angioedema or bronchospasms) to any opioid agonist Patients having previously undergone the following major surgery for high tibial osteotomy, knee arthroplasty to the affected knee 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 who are pregnant or breast-feeding. A negative pregnancy test is required prior to administration of the study medication in females of childbearing potential 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, and disorders of cognition Patients with clinically significant impaired renal, hepatic, or hematological function adrenocortical insufficiency uncontrolled hypothyroidism or hyperthyroidism, or clinically significant urinary obstruction
    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

    A Randomized, Open-Label, Single-Dose, Small Study to Evaluate the Safety and Effectiveness of Hydromorphone in Patients With Short Term, Moderate to Severe Postoperative Pain

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