Back to resultsPhase II Study of Inhaled AeroLEF for Analgesia After ACL Knee Surgery (Pain)
Primary Purpose
Pain, Post Operative Pain
Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
AeroLEF
Sponsored by
About this trial
This is an interventional treatment trial for Pain focused on measuring Pain, Post Op pain, Fentanyl, Pain Control, Surgery
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
- Queen Elizabeth II Health Sciences Centre, Capital Health
- University Health Network, Toronto Western Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single Arm
Arm Description
Outcomes
Primary Outcome Measures
The primary efficacy variable is the time to effective analgesia following initiation of dosing with AeroLEF
Secondary Outcome Measures
Time to first perceptible analgesic effect
Time and total of first rescue analgesic
Duration of effective analgesia
Pain rating scores
Adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00791804
Brief Title
Phase II Study of Inhaled AeroLEF for Analgesia After ACL Knee Surgery
Acronym
Pain
Official Title
A Phase II Study Evaluating Inhaled AeroLEF(Liposome-Encapsulated Fentanyl 500mcg/mL)for Post-Operative Pain in Adults After ACL Knee Surgery.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2008
Overall Recruitment Status
Completed
Study Start Date
February 2004 (undefined)
Primary Completion Date
June 2004 (Actual)
Study Completion Date
December 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
YM BioSciences
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 dose, or experience dose-limiting side effects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Post Operative Pain
Keywords
Pain, Post Op pain, Fentanyl, Pain Control, Surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single Arm
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
AeroLEF
Other Intervention Name(s)
Liposome-Encapsulated Fentanyl
Intervention Description
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.
Primary Outcome Measure Information:
Title
The primary efficacy variable is the time to effective analgesia following initiation of dosing with AeroLEF
Time Frame
Post operative period 12 hours
Secondary Outcome Measure Information:
Title
Time to first perceptible analgesic effect
Time Frame
Post-operative period 12 hours
Title
Time and total of first rescue analgesic
Time Frame
Post-operative period 12 hours
Title
Duration of effective analgesia
Time Frame
Post-operative period 12 hours
Title
Pain rating scores
Time Frame
Post-operative period 12 hours
Title
Adverse events
Time Frame
Post-operative period 12 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vincent Chan, MD FRCPC
Organizational Affiliation
University Health Network, Toronto
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alexander John M Clark, MD FRCPC
Organizational Affiliation
Queen Elizabeth II Health Sciences Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen Elizabeth II Health Sciences Centre, Capital Health
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1V8
Country
Canada
Facility Name
University Health Network, Toronto Western Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M8V 2Z6
Country
Canada
12. IPD Sharing Statement
Links:
URL
http://www.asaabstracts.com/strands/asaabstracts/searchresults.htm;jsessionid=3454C2BB815F1946F5043914A5077AE5?base=1&index=1&display=10&highlight=true&highlightcolor=0&bold=true&italic=false
Description
American Society of Anesthesiologists 2004 Annual Meeting, Abstract A-77
Learn more about this trial
Phase II Study of Inhaled AeroLEF for Analgesia After ACL Knee Surgery
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