Ignite Creation Date:
2024-05-05 @ 5:10 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00398788
Status:
COMPLETED
Last Update Posted:
2010-04-27
First Post:
2006-11-10
Brief Title:
A Study on Efficacy Effectiveness Safety and Impact on Quality of Life Measures of Dilaudid CR Controlled Release Hydromorphone HCl in Patients With Chronic Low Back Pain
Sponsor:
Alza Corporation DE USA
Organization:
Alza Corporation DE USA
Study Overview
Official Title:
An Open-Label Repeated-Dose Trial to Characterize the Efficacy and Safety and Impact on Quality of Life Measures of Dilaudid CR Hydromorphone HCI in Patients With Chronic Low Back Pain
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 the study was to characterize the safety effectiveness and impact on quality of life QOL measures of OROSÂ hydromorphone HCL in patients with chronic low back pain
Detailed Description:
This study was a short-term non-randomized each patient was assigned the same treatment from phase I through phase III by the researchers non-comparative open-label repeated dose study of OROS hydromorphone HCL consisting of 3 phases Phase 1 - prior opioid stabilization phase 2-7 days Phase 2 - OROS hydromorphone HCL conversion titration and stabilization phase 3 - 14 days Phase 3 - OROS hydromorphone HCL maintenance therapy phase 28 days Before Phase 1 patients must have had no change in their prescribed opioid regimen over the prior 30 days During Phase 1 patients were to have demonstrated 2 consecutive days of stable baseline oral or transdermal opioid medication
During Phase 2 patients requiring 96 mg OROS hydromorphone HCL every 24 hours converted to a once-daily dosing OROS hydromorphone HCL dose at approximately a 51 morphine to hydromorphone equivalent ratio OROS hydromorphone HCL dose titration 25-100 baseline dose was allowed every 2 days to achieve stabilization OROS hydromorphone HCL dose reduction was allowed during Phases 2 and 3 for opioid-related adverse events AEs Rescue medication Dilaudid IR immediate release was allowed during all 3 phases During Phase 3 patients attended 4 weekly study visits to provide diary information about study medication and rescue medication usage daily pain relief scores and adverse events and to receive weekly supplies of study medications OROS hydromorphone HCL tablets of 816 32 or 64 mg depending on Phase I stable baseline oral or transdermal opioid medication 2-7 days study drug dose titration was allowed every 2 days to achieve stabilization in Phase II 3-14 days Phase III maintenance therapy phase 28 days study drug dose reduction was allowed during Phase 2 and 3 for opioid-related adverse events Rescue medication of Dilaudid IR immediate release 2 4 8mg tablets were allowed during all phase
During Phase 2 patients requiring 96 mg OROS hydromorphone HCL every 24 hours converted to a once-daily dosing OROS hydromorphone HCL dose at approximately a 51 morphine to hydromorphone equivalent ratio OROS hydromorphone HCL dose titration 25-100 baseline dose was allowed every 2 days to achieve stabilization OROS hydromorphone HCL dose reduction was allowed during Phases 2 and 3 for opioid-related adverse events AEs Rescue medication Dilaudid IR immediate release was allowed during all 3 phases During Phase 3 patients attended 4 weekly study visits to provide diary information about study medication and rescue medication usage daily pain relief scores and adverse events and to receive weekly supplies of study medications OROS hydromorphone HCL tablets of 816 32 or 64 mg depending on Phase I stable baseline oral or transdermal opioid medication 2-7 days study drug dose titration was allowed every 2 days to achieve stabilization in Phase II 3-14 days Phase III maintenance therapy phase 28 days study drug dose reduction was allowed during Phase 2 and 3 for opioid-related adverse events Rescue medication of Dilaudid IR immediate release 2 4 8mg tablets were allowed during all phase
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