A Repeated-Dose Evaluation of Analgesic Use and Safety of Dilaudid SR( Hydromorphone HCI) in Patients With Chronic Cancer Pain
18 Years
N/A
Both
Analgesics, Opioid, Pain
Trial Information
A Repeated-Dose Evaluation of Analgesic Use and Safety of Dilaudid SR( Hydromorphone HCI) in Patients With Chronic Cancer Pain
This randomized (patients assigned to treatment by chance), single-blind (with respect to
dose), open-label (patients know what study treatment, not dose, they are receiving)
repeated dose study evaluating patients with chronic cancer pain was conducted in tandem
(together) with a similar protocol in patients with chronic non-malignant pain. A total of
463 patients were enrolled and evaluated in these studies. Patients receiving chronic
opioid therapy were converted to once daily OROS hydromorphone (slow release) using oral
morphine equivalents. Supplementary immediate-release (IR) hydromorphone was provided for
breakthrough pain. The dose of OROS hydromorphone (slow release) was escalated after every
2 days of therapy until no more than 3 doses of immediate-release (IR) hydromorphone were
required in a 24-hour period. Once a patient could be maintained on a stable dose of OROS
hydromorphone (slow release) for 3 consecutive days, the patient entered a 2-week
maintenance phase. Patients who completed the study were eligible for participation in an
OROS hydromorphone (slow release) long-term extension study, Study DO-109. The hypothesis
is the 24-hour controlled-release form of oral hydromorphone may provide consistent pain
relief, convenient dosing, and enhanced compliance while possibly decreasing the incidence
of side effects associated with peak (high) and trough (low) fluctuations in plasma drug
concentrations typically seen with immediate-release dosage formulations. Patients received
OROS Hydromorphone HCI (slow release) at Visit 2,3, and 4 (either 8,16,32, and/or 64mg
tablets) taken orally. OROS Hydromorphone HCI (slow release) doses were titrated after
every two days of therapy as necessary until dose stabilization occured, followed by a two
week Maintenance Therapy Phase.
Inclusion Criteria:
- Patients who have chronic cancer pain who are currently receiving strong oral or
transdermal opioid analgesics or patients suitable for advancement of therapy to step
3 on the WHO (World Health Organization) analgesic ladder
- patients who can reasonably be expected to have stable opioid requirements for the
duration of the study
Exclusion Criteria:
- Patients intolerant of or hypersensitive to hydromorphone (or other opioid agonists)
- patients who are pregnant or breast-feeding
- patients with severe respiratory compromise or severely depressed ventilatory
function
- patients with any gastrointestinal disorder or acute abdominal conditions including
pre-existing severe GI narrowing (pathologic or iatrogenic), that may affect the
absorption or transit of orally administered drugs
- patients with clinically significant impaired renal or hepatic function, Addison's
disease, hypothyroidism, prostatic hypertrophy, or urethral stricture, dysphagia or
are unable to swallow tablets or any 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
No primary efficacy variable was defined in report. Protocol variables measured included: Total daily dose of OROS hydromorphone, daily use of rescue medication, daily pain relief scores, and time/number of steps needed for dose stabilization.
Principal Investigator
Alza Corporation Clinical Trial
Investigator Role:
Study Director
Investigator Affiliation:
ALZA
Authority:
United States: Institutional Review Board
Study ID:
CR011614
NCT ID:
NCT00411034
Start Date:
Completion Date:
September 1999
Related Keywords:
- Analgesics, Opioid
- Pain
- Opioids
- Chronic Cancer Pain
- analgesic
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