Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2025-12-27 @ 5:16 AM
Study NCT ID:
NCT00818493
Status:
COMPLETED
Last Update Posted:
2012-05-17
First Post:
2009-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilot Study of the Efficacy and Safety of Q8003 in Patients Who Have Undergone Total Knee Arthroplasty or Total Hip Arthroplasty
Sponsor:
QRxPharma Inc.
Organization:
Study Overview
Official Title:
An Open-Label Pilot Study of the Analgesic Efficacy and Safety Of Q8003 and of the Conversion From IV Morphine PCA Analgesia to Q8003 or to Percocet® in Patients Who Have Undergone Primary Unilateral Total Knee Arthroplasty or Total Hip Arthroplasty
Status:
COMPLETED
Status Verified Date:
2012-05
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:
This is a Phase 2 3-arm, open label pilot study of the safety and efficacy of Q8003 in patients who have undergone primary unilateral total knee arthroplasty or total hip arthroplasty.
Detailed Description:
This Phase 2 study is a 3 arm, open-label pilot study to evaluate:
* the analgesic efficacy of a flexible ascending regimen of Q8003 compared to a low dose regimen of Q8003 (3 mg/2 mg and potentially up to 6 mg/ 4mg) and to 1-2 Percocet® 5 mg/325 mg tablets. Study drug will be administered every 4-6 hours over a 48-hour Treatment Period to inpatients with moderate to severe postoperative pain who have undergone primary unilateral total knee arthroplasty or total hip arthroplasty.
* for the flexible ascending regimen of Q8003 treatment group, to evaluate the adequacy of the algorithm for conversion of IV PCA morphine to oral morphine equivalent doses of Q8003.
* the safety of the flexible ascending regimen of Q8003 administered over a 48-hour Treatment Period.
* the analgesic efficacy of a flexible ascending regimen of Q8003 compared to a low dose regimen of Q8003 (3 mg/2 mg and potentially up to 6 mg/ 4mg) and to 1-2 Percocet® 5 mg/325 mg tablets. Study drug will be administered every 4-6 hours over a 48-hour Treatment Period to inpatients with moderate to severe postoperative pain who have undergone primary unilateral total knee arthroplasty or total hip arthroplasty.
* for the flexible ascending regimen of Q8003 treatment group, to evaluate the adequacy of the algorithm for conversion of IV PCA morphine to oral morphine equivalent doses of Q8003.
* the safety of the flexible ascending regimen of Q8003 administered over a 48-hour Treatment Period.
Study Oversight
Has Oversight DMC:
False
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?: