Ignite Creation Date:
2024-05-05 @ 5:13 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00410540
Status:
COMPLETED
Last Update Posted:
2010-04-27
First Post:
2006-12-12
Brief Title:
A Study of OROS Hydromorphone HCL vs Morphine in Cancer Pain Patients
Sponsor:
Alza Corporation DE USA
Organization:
Alza Corporation DE USA
Study Overview
Official Title:
A Randomized Double-Blind Controlled Trial of Hydromorphone Immediate and Sustained- Release vs Morphine Immediate and Sustained-release in Cancer 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 study was to demonstrate the clinical equivalence of hydromorphone and morphine immediate-release IR and sustained-release SR formulations using the worst pain in the past 24 hours item of the Brief Pain Inventory BPI The secondary objective of this study was to compare hydromorphone and morphine in the following variables other pain measures various questionnaires and safety and tolerability variables
Detailed Description:
This was a phase-3 multicenter multinational randomized patients are assigned different treatments based on chance active-controlled double-blind multiple-ascending-dose parallel-group study in adult patients with cancer pain who receive andor require strong oral or transdermal opioid analgesics 60-540 mg of oral morphine equivalents daily This study consisted of 2 phases an initial immediate release IR phase and a subsequent slow release SR phase Eligible patients were randomized 11 to receive either OROS hydromorphone HCl or morphine sulfate immediate release formulation in the immediate release phase slow release formulation in the slow release phase In the immediate release phase 2-9 days patients were started on the appropriate initial dose of immediate release medication every 4 hours q4h 6 dosesday using a 51 conversion ratio morphine equivalentshydromorphone dosage If the patient had greater than 3 breakthrough-pain episodes requiring additional pain medication in 24 hours the study medication dosage was increased at most once a day When the patient had achieved dose-stable pain control 2 days with 3 or less than 3 breakthrough-pain episodes per day the patient was permitted to continue into the slow release phase The patient was given an equivalent dosage of a slow release formulation of the same drug OROS hydromorphone HCL each day or morphine sulfate slow release two times per day administered using a double-dummy technique Dosage increases were permitted every 2 days if the patient had more than 3 breakthrough-pain episodes in 24 hours To complete the slow release phase patients had to achieve dose-stable pain control for at least 2 daysSafety assessments of physical examination labs and adverse event reporting were done OROS hydromorphone HCL slow release 8 16 32 and 64mg tablets Morphine sulfate immediate release10 20 50 mg capsulesMorphine sulfate slow release 5 30 60 90 120 160 and 200mg capsuleshydromorphone immediate release 2 4 8 mgThe immediate release medications orally every 4 hoursThe OROS hydromorphone slow release formulation orally every 24 hours and morphine slow release orally twice daily
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