Pain Clinical Trial
Official title:
A Repeated-Dose Evaluation of Analgesic Use and Safety of Dilaudid SR (Hydromorphone HCI) in Patients With Chronic Non-Malignant Pain
Verified date | April 2010 |
Source | Alza Corporation, DE, USA |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 463 |
Est. completion date | February 1999 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Alza Corporation, DE, USA |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. |
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