Phase II Study of Inhaled AeroLEF for Analgesia After ACL Knee Surgery (Pain)
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ClinicalTrials.gov Identifier: NCT00791804 |
Recruitment Status :
Completed
First Posted : November 17, 2008
Last Update Posted : November 17, 2008
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pain Post Operative Pain | Drug: AeroLEF | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 19 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 Start Date : | February 2004 |
Actual Primary Completion Date : | June 2004 |
Actual Study Completion Date : | December 2004 |

Arm | Intervention/treatment |
---|---|
Experimental: Single Arm |
Drug: AeroLEF
Inhaled AeroLEF (Liposome-Encapsulated Fentanyl 500 mcg/mL)
Other Name: Liposome-Encapsulated Fentanyl |
- The primary efficacy variable is the time to effective analgesia following initiation of dosing with AeroLEF [ Time Frame: Post operative period 12 hours ]
- Time to first perceptible analgesic effect [ Time Frame: Post-operative period 12 hours ]
- Time and total of first rescue analgesic [ Time Frame: Post-operative period 12 hours ]
- Duration of effective analgesia [ Time Frame: Post-operative period 12 hours ]
- Pain rating scores [ Time Frame: Post-operative period 12 hours ]
- Adverse events [ Time Frame: Post-operative period 12 hours ]

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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00791804
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 | University Health Network, Toronto | |
Principal Investigator: | Alexander John M Clark, MD FRCPC | Queen Elizabeth II Health Sciences Centre |
Responsible Party: | YM BioSciences Inc.., YM BioSciences |
ClinicalTrials.gov Identifier: | NCT00791804 |
Other Study ID Numbers: |
DLXLEF0 |
First Posted: | November 17, 2008 Key Record Dates |
Last Update Posted: | November 17, 2008 |
Last Verified: | November 2008 |
Pain Post Op pain Fentanyl Pain Control Surgery |
Pain, Postoperative Postoperative Complications Pathologic Processes Pain Neurologic Manifestations Fentanyl Analgesics, Opioid Narcotics Central Nervous System Depressants |
Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Adjuvants, Anesthesia Anesthetics, Intravenous Anesthetics, General Anesthetics |