A Repeated-Dose Evaluation of Use of a Pain Relieving Drug and Safety of OROS Hydromorphone HCI in Patients With Chronic Cancer Pain
Information source: Alza Corporation, DE, USA
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain; Analgesics, Opioid
Intervention: OROS Hydromorphone HCI (Drug)
Phase: Phase 3
Sponsored by: Alza Corporation, DE, USA
Official(s) and/or principal investigator(s):
Alza Corporation Clinical Trial, Study Director, Affiliation: Alza Corporation, DE, USA
The purpose of this repeated dose study is to develop recommended dosing information for
initiation of therapy with OROS Hydromorphone HCI (slow release) in patients with chronic
cancer pain converting from other strong oral or transdermal opioids. It will also assist in
the development of a recommended starting dose by which patients can be titrated to an
appropriate maintenance dose of OROS hydromorphone HCI (slow release). The safety profile for
OROS Hydromorphone HCI (slow release) will also be evaluated.
Official title: A Repeated-Dose Evaluation of Analgesic Use and Safety of Dilaudid SR( Hydromorphone HCI) in Patients With Chronic Cancer Pain
Study design: Treatment, Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Primary outcome: 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.
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.
Minimum age: 18 Years.
Maximum age: N/A.
- 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) analgestic ladder
- Patients who can reasonably be expected to have stable opioid requirements for the
duration of the study
- 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
- 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
Locations and Contacts
Ending date: September 1999
Last updated: April 17, 2008