Ignite Creation Date:
2024-05-05 @ 5:14 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00410644
Status:
COMPLETED
Last Update Posted:
2010-04-27
First Post:
2006-12-12
Brief Title:
A Repeated-Dose Evaluation of a Pain Relieving Drug Use and Safety of OROS Hydromorphone HCI in Patients With Chronic Non-Malignant Pain
Sponsor:
Alza Corporation DE USA
Organization:
Alza Corporation DE USA
Study Overview
Official Title:
A Repeated-Dose Evaluation of Analgesic Use and Safety of Dilaudid SR Hydromorphone HCI in Patients With Chronic Non-Malignant 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 repeated dose study is to develop recommended dosing information for initiation of therapy with OROS Hydromorphone in patients with chronic non-malignant pain converting from other strong oral or transdermal opioids It will also assist in the development of a recommended starting dose by which patients can be titrated to an appropriate maintenance dose of OROS Hydromorphone HCI The safety profile for OROS Hydromorphone HCI will also be evaluated
Detailed Description:
This single-blind with respect to dose repeated dose study evaluating patients with chronic non-malignant pain was conducted in tandem with a similar protocol in patients with chronic cancer pain A total of 463 patients were enrolled and evaluated in these studies Patients receiving chronic opioid therapy were converted to once daily OROS hydromorphone using oral morphine equivalents Supplementary immediate-release IR hydromorphone was provided for breakthrough pain The dose of OROS hydromorphone was escalated after every 2 days of therapy until no more than 3 doses of immediate-releaseIR hydromorphone were required in a 24-hour period Once a patient could be maintained on a stable dose of OROS hydromorphone for 3 consecutive days the patient entered a 2-week maintenance phase Patients who completed the study were eligible for participation in an OROS hydromorphone long-term extension study Study DO-109 The hypothesis is the 24-hour controlled-release form of oral hydromorphone may provide consistent pain relief convenient dosing and enhanced compliance while possibly decreasing the incidence of side effects associated with peak high and trough low fluctuations in plasma drug concentrations typically seen with immediate-release dosage formulations Patients received OROS Hydromorphone HCI at Visit 23 and 4either 81632 andor 64mg tablets taken orally OROS Hydromorphone HCI doses were titrated after every two days of therapy as necessary until dose stabilization occurred followed by a two week Maintenance Therapy 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