Overview

A Repeated-Dose Evaluation of a Pain Relieving Drug Use and Safety of OROS Hydromorphone HCI in Patients With Chronic Non-Malignant Pain

Status:
Completed
Trial end date:
1999-02-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this repeated dose study is to develop recommended dosing information for initiation of therapy with OROS Hydromorphone in patients with chronic non-malignant 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. The safety profile for OROS Hydromorphone HCI will also be evaluated.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Alza Corporation, DE, USA
Treatments:
Analgesics
Hydromorphone
Criteria
Inclusion Criteria:

- Patients who have chronic non-malignant pain, including pain associated with AIDS, who
are currently receiving strong oral or transdermal opioid analgesics, or patients who
are currently receiving opioids plus non-opioid combination analgesics, and have
persisting pain

- patients who require at least 45 mg of oral morphine or opioid equivalent every 24
hours for the management of chronic non-malignant pain

- 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 have dysphagia or are unable to swallow tablets

- patients who are pregnant or breast-feeding

- patients with severe respiratory compromise or severely depressed ventilatory function

- 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 or have an acute abdominal condition that may be obscured by
opioids

- patients with clinically significant impaired renal or hepatic function, Addison's
disease, hypothyroidism, prostatic hypertrophy, or urethral stricture

- patients who are known active drug abusers or alcoholics

- patients with 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