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

NCT00791804 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2008-11-17

No results posted yet for this study

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.

Conditions

  • Pain
  • Post Operative Pain

Interventions

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.

Sponsors & Collaborators

  • YM BioSciences

    lead INDUSTRY

Principal Investigators

  • Vincent Chan, MD FRCPC · University Health Network, Toronto

  • Alexander John M Clark, MD FRCPC · Queen Elizabeth II Health Sciences Centre

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-02-29
Primary Completion
2004-06-30
Completion
2004-12-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00791804 on ClinicalTrials.gov