NCT00791804

Phase II Study of Inhaled AeroLEF for Analgesia After ACL Knee Surgery

A Phase II Study Evaluating Inhaled AeroLEF(Liposome-Encapsulated Fentanyl 500mcg/mL)for Post-Operative Pain in Adults After ACL Knee Surgery.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: YM BioSciences · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pain
• Post Operative Pain

Interventions

Type	Name	Description
DRUG	AeroLEF	Inhaled AeroLEF (Liposome-Encapsulated Fentanyl 500 mcg/mL) * for nebulized administration as required by the patient. * Up to a 6 mL volume (2 x 3 mL doses) containing 500 mcg/ml fentanyl.

Timeline

• Start date: 2004-02-01
• Primary completion: 2004-06-01
• Completion: 2004-12-01
• First posted: 2008-11-17
• Last updated: 2008-11-17

Locations

2 sites across 1 country: Canada