Status:
COMPLETED
A Repeated-Dose Evaluation of Use of a Pain Relieving Drug and Safety of OROS Hydromorphone HCI in Patients With Chronic Cancer Pain
Lead Sponsor:
Alza Corporation, DE, USA
Conditions:
Analgesics, Opioid
Pain
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 HCI (slow release) in patients with chronic cancer pain convertin...
Detailed Description
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 evalu...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 1999
Estimated Enrollment :
463 Patients enrolled
Trial Details
Trial ID
NCT00411034
End Date
September 1 1999
Last Update
April 27 2010
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