Clinical trial · Interventional
Safety and Tolerability of Long-Term Administration of Hydromorphone HCI CR (Controlled Release)
Safety and Tolerability of Long-term Administration of Dilaudid CR (Hydromorphone HCI)
NCT00410748CI-TRIAL-00003402completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of study was to characterize the safety and tolerability of long-term repeated dosing of OROS hydromorphone controlled release tablets (8,16,32, and 64 mg) in patients with chronic cancer pain or chronic non-malignant pain.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Analgesics, Opioid | — | UNRESOLVED | — |
| Pain | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| OROS hydromorphone HCI CR | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Effectiveness of OROS hydromorphone was maintained throughout the study. OROS hydromorphone provided moderate pain relief in patients with chronic cancer/chronic non-malignant pain.
Secondary outcomes (1)
- measure
- Long term administration of OROS hydromorphone was safe and well tolerated.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients who have chronic cancer or chronic non-malignant pain, including pain associated with AIDS, who have successfully completed a OROS hydromorphone HCI (controlled release) short-term study (i.e. Study DO-104, DO-105, or DO-119) * Patients who require at least 8 mg of hydromorphone HCI every 24 hours for the management of chronic cancer or chronic non-malignant pain * Patients whose opioid requirements have been stable as demonstrated in a OROS hydromorphone HCI (controlled release) short-term study Exclusion Criteria: * Patients intolerant of or hypersensitive to hydromorphone (or other opioid agonists) * Patients who are pregnant or breast-feeding * 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 * Patients with clinically significant impaired renal or hepatic function, Addison's disease, hypothyroidism, prostatic hypertrophy, or urethral stricture * 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 * Patients who are known active drug abusers or alcoholics
References
Publications (1)
- DERIVEDWallace M, Moulin DE, Rauck RL, Khanna S, Tudor IC, Skowronski R, Thipphawong J. Long-term safety, tolerability, and efficacy of OROS hydromorphone in patients with chronic pain. J Opioid Manag. 2009 Mar-Apr;5(2):97-105. doi: 10.5055/jom.2009.0011. PMID 19507806