Ignite Creation Date:
2024-05-05 @ 5:13 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00411268
Status:
COMPLETED
Last Update Posted:
2010-04-27
First Post:
2006-12-12
Brief Title:
Safety Effectiveness and Impact on Quality of Life on Long-Term Administration of OROS Hydromorphone Slow-Release in Patients With Chronic Low Back Pain
Sponsor:
Alza Corporation DE USA
Organization:
Alza Corporation DE USA
Study Overview
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
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 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
Detailed Description:
This open label extension study characterized the safety effectiveness and impact on quality of life of OROS hydromorphone slow release with long-term repeated dosing among patients with chronic low back pain who previously completed short-term Study DO-127 with OROS hydromorphone slow release Up to 150 patients were to be enrolled and evaluated Patients were enrolled in this study immediately following Study DO-127 Patients continued their therapy with OROS hydromorphone slow release at the stable dose previously identified in the short-term study The patients initial prescribed dose of OROS hydromorphone slow release in Study DO-127X was the same as the last dose of OROS hydromorphone slow release in Study DO-127 Patients returned monthly for evaluations during this extension interval Adjustments to dose were performed as needed at the Investigators discretion The duration of this study was six months Safety assessments included vital signs and physical examination at start during and end of study 8 16 32 and 64 mg tablets of OROS hydromorphone dose will be at Investigators discretion slow release tablets were taken orally daily for the duration of the six month study
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