Status:
COMPLETED
A Repeated-Dose Evaluation of a Pain Relieving Drug Use and Safety of OROS Hydromorphone HCI in Patients With Chronic Non-Malignant Pain
Lead Sponsor:
Alza Corporation, DE, USA
Conditions:
Pain
Analgesics
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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...
Detailed Description
This single-blind (with respect to dose), repeated dose study evaluating patients with chronic non-malignant pain was conducted in tandem with a similar protocol in patients with chronic cancer pain. ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 1999
Estimated Enrollment :
463 Patients enrolled
Trial Details
Trial ID
NCT00410644
End Date
February 1 1999
Last Update
April 27 2010
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