drugset / Trial / NCT00410878
A Repeated Dose Study of the Metabolism and Action Evaluation of OROS Hydromorphone HCI (Slow Release) Tablets in Patients With Chronic Pain
Non-randomizedSingle-groupOpen-labelTreatment
Summary
The purpose of this study was to characterize the steady-state pharmacokinetic (metabolism and action) profile of OROS hydromorphone HCI (slow release) in patients who required opioid therapy on a daily basis for chronic pain conditions. Patients stabilized on prior opioids were converted to OROS hydromorphone slow release and titrated (slowly increased or decreased) to adequate analgesia (pain relief). They were maintained at that dose for 4-10 days and had blood samples drawn over 24 hours on the last day of study.
Timeline
- Start
- —
- Primary completion
- —
- Completion
- 1999-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Hydromorphone | Other / unclassified | 8 mg | Oral |
| Subject | Hydromorphone | Other / unclassified | 16 mg | Oral |
| Subject | Hydromorphone | Other / unclassified | 32 mg | Oral |
| Subject | Hydromorphone | Other / unclassified | 64 mg | Oral |
Indications
No indication recorded.