Ignite Creation Date:
2024-05-05 @ 5:14 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00411164
Status:
COMPLETED
Last Update Posted:
2013-07-08
First Post:
2006-12-12
Brief Title:
A Study to Evaluate the Effectiveness and Safety of Slow Release Hydromorphone HCL for Treatment of Patients With Osteoarthritis
Sponsor:
Alza Corporation DE USA
Organization:
Alza Corporation DE USA
Study Overview
Official Title:
A Phase 3 Randomized Double-Blind Fixed-Dose Parallel Group Comparison of Controlled-Release Hydromorphone HCI vs Placebo in Subjects With Osteoarthritis
Status:
COMPLETED
Status Verified Date:
2013-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study was to compare the analgesic a drug that relieves pain effectiveness and safety of OROS hydromorphone HCI slow release 8 mg and 16 mg to placebo no drug in patients with osteoarthritis OA
Detailed Description:
This was a phase 3 randomized patients are assigned different treatments based on chance placebo-controlled double-blind fixed-dose parallel-group multicenter study in adult patients with OA osteoarthritis who were unable to consistently control or treat their pain with nonopioid medications or who had received an opioid for treatment of pain Eligible patients were randomized in an equal ratio to receive 1 of 3 treatments OROS hydromorphone HCI slow release 8mg OROS hydromorphone HCI slow release 16 mg or placebo no drug All patients could take acetaminophen less than or equal to 2000 mg per day as rescue medication for osteoarthritic pain Rescue medication was not permitted during the washout period or 6 hours before an assessment of effectiveness The study was comprised of the following periods an analgesic pain reliever taper and washout period less than or equal to 2 weeks a Titration increasePhase less than or equal to 16 days a Maintenance Phase 12 weeks and a study drug taper period less than or equal to 1 week At the end of the washout period all patients received OROS hydromorphone HCI slow release 8 mg or matching placebo to be taken once daily After 1 week patients were to return to the study site and receive new supplies of study drug During the second week of titration increase patients randomized to the OROS hydromorphone slow release 16 mg group had their dose increased from 8 mg daily to 16 mg daily of OROS hydromorphone slow release No dose adjustments were allowed After completing the Maintenance Phase or upon early termination study drug was tapered for up to 1 week as follows one 8 mg tablet or placebo once daily for the first 2 days then taken every other day as appropriate to taper off the study medication Safety assessments of physical examination vital signs labs and adverse event reporting were done at baseline termination throughout the study The primary measurement was the time-interval weighted area under the curveAUC divided by the maximum AUC benefit possible for an individual The AUC was a measure of cumulative pain intensity differences from baseline for the Titration and Maintenance phases At termination patients were assigned their baseline pain value for the remainder of the trial baseline observation carried forward BOCF or the last available pain value for the remainder of the trial last observation carried forward LOCF Western Ontario and McMaster Osteoarthritis Index WOMAC overall index score physical function joint stiffness subscales were analyzed using the AUC ratio and change from baseline using no imputation and the baseline observation carried forward BOCF and last observation carried forward LOCF imputation methods The medical outcome study MOS sleep scale was also analyzed per protocol OROS hydromorphone slow release 8 mg and 16 mg tablets and placebo taken orally once daily for 17 weeks
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