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Sponsored by: |
YM BioSciences |
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Information provided by: | YM BioSciences |
ClinicalTrials.gov Identifier: | NCT00286065 |
The purpose of this study is to determine the effect of pain relief with AeroLEF in adult patients, following orthopedic surgery.
Condition | Intervention | Phase |
---|---|---|
Pain |
Drug: AeroLEF |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Efficacy Study |
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 |
Estimated Enrollment: | 123 |
Study Start Date: | January 2006 |
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patient is able to communicate effectively with study personnel
Exclusion Criteria:
Canada, Ontario | |
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 |
Study ID Numbers: | DLXLEF-AP4 |
Study First Received: | January 31, 2006 |
Last Updated: | June 26, 2007 |
ClinicalTrials.gov Identifier: | NCT00286065 History of Changes |
Health Authority: | Canada: Health Canada |
Pain Fentanyl Analgesics Opioid Inhalation |
Fentanyl Pain Analgesics Pain, Postoperative |