Status:
COMPLETED
Phase II Study of Inhaled AeroLEF for Analgesia After ACL Knee Surgery
Lead Sponsor:
YM BioSciences
Conditions:
Pain
Post Operative Pain
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief 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.
Detailed Description
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...
Eligibility Criteria
Inclusion
- Male or female between ages 18 years and 60 years.
- A body mass index of between 18 and 30, inclusive.
- If a female of child-bearing potential, the patient must have a negative urine pregnancy test at screening and baseline.
- Scheduled for elective ACL arthroscopic knee repair surgery, and meet the criteria of the American Society of Anesthesiologists \[ASA\] Physical Status Criteria of Class I or Class II, and suitability for an anesthetic plan limited to general anesthesia (inhalation/IV) with post-operative PCA initiated in a PACU setting and not requiring CPM before the 12 hours post surgery observation is completed.
- Scheduled for a morning surgery and anticipating remaining in the hospital for an overnight stay.
- Normal laboratory values for clinical chemistry, haematology and urinalysis. If a patient has abnormal clinically significant laboratory values, inclusion will be permitted at the discretion of the investigator .
- Physical examination with no clinically relevant findings as determined by the investigator.
- Able to demonstrate the ability to understand the requirements of the study, willingness to provide written informed consent (prior to any study-related procedures being performed) and able to adhere to the study restrictions, and return for the required assessments.
Exclusion
- History of addiction to drugs or alcohol.
- Exposure to any investigational drug within the 30 days prior to enrolment.
- Documented hypersensitivity to fentanyl or other opioid analgesics
- Documented hypersensitivity/allergy to the components of the liposomes used in the AeroLEF formulation
- History of pulmonary, cardiovascular, neurologic, endocrine, hepatic, GI, or kidney disease or therapy that would jeopardize the patient's well-being by participation in this study (excluded by ASA I and II categories)
- Currently receiving treatment, or have received treatment in the previous two weeks, with antidepressant or antipsychotic drugs (including monoamine oxidase inhibitors).
- Clinically significant ongoing medical conditions.
- Currently receiving treatment for chronic pain.
- Current therapy with narcotic or CNS-depressant medications.
- Current chronic therapy with NSAIDs, ASA or acetaminophen within the previous 7 days.
- Patient, who in the opinion of the investigator, is mentally or emotionally unsuitable to participate, or unable/unwilling to comply with the study assessments.
- Blood donation or other blood loss within 45 days prior to enrolment in the study totalling 100 mL or greater.
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2004
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00791804
Start Date
February 1 2004
End Date
December 1 2004
Last Update
November 17 2008
Active Locations (2)
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1
Queen Elizabeth II Health Sciences Centre, Capital Health
Halifax, Nova Scotia, Canada, B3H 1V8
2
University Health Network, Toronto Western Hospital
Toronto, Ontario, Canada, M8V 2Z6