Safety, Effectiveness, and Impact on Quality of Life on Long-Term Administration of OROS Hydromorphone Slow-Release in Patients With Chronic Low Back Pain
CompletedPhase 3NCT00411268
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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 open-label, extension study is to characterize the safety, effectiveness, and impact on quality of life measures of long-term repeated dosing of OROS hydromorphone slow release (8, 16, 32 and 64 mg tablets) in patients with chronic low back pain.
Study details
- Official title
- Safety, Efficacy and Impact on Quality of Life of Long-Term Administration of Dilaudid CR (Hydromorphone HCI) in Patients With Chronic Low Back Pain
- Conditions
- Interventions
- Drug: OROS hydromorphone HCI SR (slow release)
- 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 low back pain who have successfully completed short-term Study DO-127 with OROS hydromorphone slow release * Patients who require at least 8 mg of hydromorphone HCI (slow release) every 24 hours for the management of chronic low back pain * Patients whose opioid requirements have been stable as demonstrated in short-term Study DO-127 with OROS hydromorphone slow release 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 significant CNS disorder, including but not limited to head injury, intracranial lesion, increased intracranial pressure, seizure disorder, stroke within the past 6 months, disorders of cognition, any clinically significant impaired renal or hepatic function, Addison's disease, hypothyroidism, prostatic hypertrophy, or urethral stricture * Patients who may be at risk for serious decreases in blood pressure upon taking an opioid analgesic
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00411268