Ignite Creation Date:
2024-05-05 @ 5:15 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00410748
Status:
COMPLETED
Last Update Posted:
2010-04-27
First Post:
2006-12-12
Brief Title:
Safety and Tolerability of Long-Term Administration of Hydromorphone HCI CR Controlled Release
Sponsor:
Alza Corporation DE USA
Organization:
Alza Corporation DE USA
Study Overview
Official Title:
Safety and Tolerability of Long-term Administration of Dilaudid CR Hydromorphone HCI
Status:
COMPLETED
Status Verified Date:
2010-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of study was to characterize the safety and tolerability of long-term repeated dosing of OROS hydromorphone controlled release tablets 81632 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None