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Sponsored by: |
YM BioSciences |
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Information provided by: | YM BioSciences |
ClinicalTrials.gov Identifier: | NCT00791804 |
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.
Condition | Intervention | Phase |
---|---|---|
Pain Post Operative Pain |
Drug: AeroLEF |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Study Evaluating Inhaled AeroLEF(Liposome-Encapsulated Fentanyl 500mcg/mL)for Post-Operative Pain in Adults After ACL Knee Surgery. |
Enrollment: | 19 |
Study Start Date: | February 2004 |
Study Completion Date: | December 2004 |
Primary Completion Date: | June 2004 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Single Arm: Experimental |
Drug: AeroLEF
Inhaled AeroLEF (Liposome-Encapsulated Fentanyl 500 mcg/mL)
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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.
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Canada, Nova Scotia | |
Queen Elizabeth II Health Sciences Centre, Capital Health | |
Halifax, Nova Scotia, Canada, B3H 1V8 | |
Canada, Ontario | |
University Health Network, Toronto Western Hospital | |
Toronto, Ontario, Canada, M8V 2Z6 |
Principal Investigator: | Vincent Chan, MD FRCPC | Toronto Western Hospital |
Principal Investigator: | Alexander John M Clark, MD FRCPC | Queen Elizabeth II Health Sciences Centre |
Responsible Party: | YM BioSciences ( YM BioSciences Inc.. ) |
Study ID Numbers: | DLXLEF0 |
Study First Received: | November 13, 2008 |
Last Updated: | November 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00791804 History of Changes |
Health Authority: | Canada: Health Canada |
Pain Post Op pain Fentanyl Pain Control Surgery |
Anesthetics, Intravenous Fentanyl Adjuvants, Immunologic Anesthetics Central Nervous System Depressants Pain Narcotics |
Signs and Symptoms Postoperative Complications Anesthetics, General Analgesics Peripheral Nervous System Agents Analgesics, Opioid Pain, Postoperative |
Anesthetics, Intravenous Fentanyl Physiological Effects of Drugs Anesthetics Central Nervous System Depressants Pain Narcotics Pharmacologic Actions Adjuvants, Anesthesia Signs and Symptoms |
Pathologic Processes Postoperative Complications Anesthetics, General Sensory System Agents Therapeutic Uses Peripheral Nervous System Agents Analgesics Central Nervous System Agents Analgesics, Opioid Pain, Postoperative |