A Repeated-Dose Evaluation of Use of a Pain Relieving Drug and Safety of OROS Hydromorphone HCI in Patients With Chronic Cancer Pain
CompletedPhase 3NCT00411034
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- A Repeated-Dose Evaluation of Analgesic Use and Safety of Dilaudid SR( Hydromorphone HCI) in Patients With Chronic Cancer Pain
- Conditions
- Analgesics, Opioid
- Pain
- Interventions
- Drug: OROS Hydromorphone HCI
- Sponsor
- Alza Corporation, DE, USA
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Total sites listed
- 0
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * 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 Criteria: * 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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00411034