Study to Determine Efficacy and Safety of Inhaled AeroLEF in the Treatment of Acute Post-op Pain in Adult Patients Undergoing Elective Orthopedic Surgery
This study has been completed.
Information provided by:
First received: January 31, 2006
Last updated: June 26, 2007
Last verified: June 2007
The purpose of this study is to determine the effect of pain relief with AeroLEF in adult patients, following orthopedic surgery.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Primary Purpose: Treatment
|Official Title:||Multi-Centre Placebo-Controlled Randomized 2 Part Study to Determine Efficacy and Safety of Inhaled AeroLEF in the Treatment of Acute Post-Op Pain in Adult Patients Undergoing Elective Orthopedic Surgery|
Further study details as provided by YM BioSciences:
Primary Outcome Measures:
- - Summed Pain Relief plus Pain Intensity Difference (SPRID) scores during the interval from Baseline post-surgery to 4 hours after the initial dose following surgery
Secondary Outcome Measures:
- Sum of the Pain Intensity Difference scores (SPID) for 4 hours after the start of the initial dose
- Sum of the Pain Relief scores (TOTPAR) for the 4 hours following the start of the initial dose
- Total use of rescue analgesic drug.
- Time to effective pain relief (measured by stopwatch).
- Duration of effective pain relief as measured by the interval between time to onset of effective pain relief and time to first use of rescue drug (both measured by stopwatch) or next dose of study drug.
- Clinician Global Impression (CGI) scores at 4 and 12 hours after the start of the initial post-surgery dose of study drug.
- Patient Treatment Satisfaction Rating scores at 4 and 12 hours after the start of the initial post-surgery dose of study drug.
|Study Start Date:||January 2006|
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00286065
|Toronto Western Hospital|
|Toronto, Ontario, Canada|
Sponsors and Collaborators
|Principal Investigator:||Vincent Chan, M.D.||University Health Network, Toronto|
|Principal Investigator:||Kenneth Chisholm, M.D||Queen Elizabeth II Infirmary|