NCT00410748

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 388 (actual)
• Sponsor: Alza Corporation, DE, USA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This was a Phase 3, multicenter, open-label, extension study to characterize the safety and tolerability of long-term, repeated dosing of OROS hydromorphone in patients with chronic cancer or chronic non-malignant pain. Patients with chronic cancer or chronic non-malignant pain had completed an OROS hydromorphone short-term study (DO-104, DO-105, DO-119) of approximately 4 weeks duration. During this study, patients continued to receive the dose of OROS hydromorphone that they had been receiving in the short-term study, with dose adjustments as needed to control pain and adverse events. Patients were treated on an outpatient basis. The study was extended from 1 year to up to 2 years in duration. Monthly evaluations of patients treated with OROS hydromorphone for chronic pain were performed to identify adverse events, construct a safety and tolerability profile, and assess efficacy. Dose adjustments were permitted to provide for disease progression, pain control, and adverse events. Quarterly physical examinations were performed to detect significant changes in the underlying condition of patients or changes that may have been associated with long-term opioid therapy. OROS hydromorphone 24 hour controlled release tablets in 8, 16, 32 and 64 mg were ingested orally daily up to 1 year with dose adjustments as needed to control pain and adverse events.

Conditions

• Pain
• Analgesics, Opioid

Interventions

Type	Name	Description
DRUG	OROS hydromorphone HCI CR

Timeline

• Completion: 2000-06-01
• First posted: 2006-12-13
• Last updated: 2010-04-27