Ignite Creation Date:
2024-05-05 @ 5:09 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00399048
Status:
COMPLETED
Last Update Posted:
2010-04-27
First Post:
2006-11-10
Brief Title:
An Effectiveness Safety and Quality of Life Measures With Hydromorphone HCL Dilaudid CR Controlled Release
Sponsor:
Alza Corporation DE USA
Organization:
Alza Corporation DE USA
Study Overview
Official Title:
A Randomized Repeated- Dose Parallel-Group Comparison of Safety Efficacy and Quality of Life Measures With Dilaudid CR Hydromorphone HCI or Oxycontin Oxycodone HCI in Patients With Chronic Osteoarthritis
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 characterize the effectiveness and safety of OROS hydromorphone HCL and OxyContin in patients with chronic osteoarthritis OA of the knee or hip who are receiving chronic nonsteroidal anti-inflammatory drug NSAID or other nonsteroidal non-opioid analgesic ie acetaminophen or aspirin therapy
Detailed Description:
This was a multicenter open-label randomized patients are assigned different treatments based on chance dose-titration parallel-group study characterizing the effectiveness and safety of OROS hydromorphone HCL and OxyContin in adult patients with osteoarthritis OA of the knee or hip who were unable to consistently control or treat their osteoarthritis pain with non opioid medications or with as-needed use of an opioid analgesic The study consisted of a 14-day period for randomization dose-titration and stabilization followed by a 4-week maintenance phase Eligible patients were randomized equally to begin therapy with either OROS hydromorphone HCL 8 mg daily or OxyContin 10 mg twice daily Upward dose titration doses with increase in titration from the starting doses was allowed every 2 days based on pain relief and opioid-related side effects The dose was to have been titrated to provide the best balance between pain relief and side effects After 14 days if therapeutic efficacy with dose stabilization had been documented the patient was allowed to begin the 4-week maintenance phase The expected primary efficacy variable endpoints were The mean pain relief score at endpoint defined as the mean of the last 2 non missing pain relief scores during the Maintenance Phase and the days from study medication initiation to the third day of moderate to complete pain relief on the patients final titrated dose as reported in the patient diary during the Randomization Titration and Stabilization Phase Safety was evaluated by adverse events AEs vital signs and physical examinations OROS hydromorphone HCL 8mg tablet orally daily or OxyContin 10mg tablet orally daily Upward dose titration from the starting doses was allowed every 2 days based on pain relief and opioid-related side effects After 14 days of efficacy with dose stabilization patient was allowed to begin the 4 week maintenance 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