Ignite Creation Date:
2025-12-24 @ 7:57 PM
Ignite Modification Date:
2026-01-01 @ 7:17 AM
Study NCT ID:
NCT00791804
Status:
COMPLETED
Last Update Posted:
2008-11-17
First Post:
2008-11-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase II Study of Inhaled AeroLEF for Analgesia After ACL Knee Surgery
Sponsor:
YM BioSciences
Organization:
Study Overview
Official Title:
A Phase II Study Evaluating Inhaled AeroLEF(Liposome-Encapsulated Fentanyl 500mcg/mL)for Post-Operative Pain in Adults After ACL Knee Surgery.
Status:
COMPLETED
Status Verified Date:
2008-11
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:
Pain
Brief Summary:
To evaluate the safety and efficacy of self-titration to effective analgesia with inhaled AeroLEF in patients with moderate/severe acute pain in the post-surgical setting.
Detailed Description:
After elective ACL knee surgery, consented patients will receive a single dose of AeroLEF for moderate/severe acute pain. Patients stop dosing if they achieve analgesia, complete the maximum available dose, or experience dose-limiting side effects.
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?: