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Phase II Study of Inhaled AeroLEF for Analgesia After ACL Knee Surgery (Pain)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00791804
Recruitment Status : Completed
First Posted : November 17, 2008
Last Update Posted : November 17, 2008
Information provided by:
YM BioSciences

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.

Condition or disease Intervention/treatment Phase
Pain Post Operative Pain Drug: AeroLEF Phase 2

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.

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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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Single Arm Drug: 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 Name: Liposome-Encapsulated Fentanyl

Primary Outcome Measures :
  1. 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 Measures :
  1. Time to first perceptible analgesic effect [ Time Frame: Post-operative period 12 hours ]
  2. Time and total of first rescue analgesic [ Time Frame: Post-operative period 12 hours ]
  3. Duration of effective analgesia [ Time Frame: Post-operative period 12 hours ]
  4. Pain rating scores [ Time Frame: Post-operative period 12 hours ]
  5. Adverse events [ Time Frame: Post-operative period 12 hours ]

Information from the National Library of Medicine

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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:

  1. Male or female between ages 18 years and 60 years.
  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:

  1. History of addiction to drugs or alcohol.
  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.

Information from the National Library of Medicine

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

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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
Sponsors and Collaborators
YM BioSciences
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Principal Investigator: Vincent Chan, MD FRCPC University Health Network, Toronto
Principal Investigator: Alexander John M Clark, MD FRCPC Queen Elizabeth II Health Sciences Centre
Additional Information:
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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
Keywords provided by YM BioSciences:
Post Op pain
Pain Control
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Neurologic Manifestations
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General