Study to Determine Efficacy and Safety of Inhaled AeroLEF in the Treatment of Acute Post-op Pain in Adult Patients Undergoing Elective Orthopedic Surgery
|ClinicalTrials.gov Identifier: NCT00286065|
Recruitment Status : Completed
First Posted : February 2, 2006
Last Update Posted : June 27, 2007
|Condition or disease||Intervention/treatment||Phase|
|Pain||Drug: AeroLEF||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||123 participants|
|Intervention Model:||Factorial Assignment|
|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|
|Study Start Date :||January 2006|
- - 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
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00286065
|Toronto Western Hospital|
|Toronto, Ontario, Canada|
|Principal Investigator:||Vincent Chan, M.D.||University Health Network, Toronto|
|Principal Investigator:||Kenneth Chisholm, M.D||Queen Elizabeth II Infirmary|