Phase II Study of Inhaled AeroLEF for Analgesia After ACL Knee Surgery
NCT ID: NCT00791804
Last Updated: 2008-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
19 participants
INTERVENTIONAL
2004-02-29
2004-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Single Arm
AeroLEF
Inhaled AeroLEF (Liposome-Encapsulated Fentanyl 500 mcg/mL)
* for nebulized administration as required by the patient.
* Up to a 6 mL volume (2 x 3 mL doses) containing 500 mcg/ml fentanyl.
Interventions
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AeroLEF
Inhaled AeroLEF (Liposome-Encapsulated Fentanyl 500 mcg/mL)
* for nebulized administration as required by the patient.
* Up to a 6 mL volume (2 x 3 mL doses) containing 500 mcg/ml fentanyl.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. A body mass index of between 18 and 30, inclusive.
3. If a female of child-bearing potential, the patient must have a negative urine pregnancy test at screening and baseline.
4. 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.
5. Scheduled for a morning surgery and anticipating remaining in the hospital for an overnight stay.
6. 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 .
7. Physical examination with no clinically relevant findings as determined by the investigator.
8. 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 Criteria
2. Exposure to any investigational drug within the 30 days prior to enrolment.
3. Documented hypersensitivity to fentanyl or other opioid analgesics
4. Documented hypersensitivity/allergy to the components of the liposomes used in the AeroLEF formulation
5. 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)
6. Currently receiving treatment, or have received treatment in the previous two weeks, with antidepressant or antipsychotic drugs (including monoamine oxidase inhibitors).
7. Clinically significant ongoing medical conditions.
8. Currently receiving treatment for chronic pain.
9. Current therapy with narcotic or CNS-depressant medications.
10. Current chronic therapy with NSAIDs, ASA or acetaminophen within the previous 7 days.
11. Patient, who in the opinion of the investigator, is mentally or emotionally unsuitable to participate, or unable/unwilling to comply with the study assessments.
12. Blood donation or other blood loss within 45 days prior to enrolment in the study totalling 100 mL or greater.
18 Years
60 Years
ALL
No
Sponsors
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YM BioSciences
INDUSTRY
Responsible Party
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YM BioSciences
Principal Investigators
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Vincent Chan, MD FRCPC
Role: PRINCIPAL_INVESTIGATOR
University Health Network, Toronto
Alexander John M Clark, MD FRCPC
Role: PRINCIPAL_INVESTIGATOR
Queen Elizabeth II Health Sciences Centre
Locations
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Queen Elizabeth II Health Sciences Centre, Capital Health
Halifax, Nova Scotia, Canada
University Health Network, Toronto Western Hospital
Toronto, Ontario, Canada
Countries
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Related Links
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American Society of Anesthesiologists 2004 Annual Meeting, Abstract A-77
Other Identifiers
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DLXLEF0
Identifier Type: -
Identifier Source: org_study_id