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

A Phase II Study Evaluating Inhaled AeroLEF(Liposome-Encapsulated Fentanyl 500mcg/mL)for Post-Operative Pain in Adults After ACL Knee Surgery.

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.

Study Overview

• Status: Completed
• Conditions: Pain; Post Operative Pain
• Intervention / Treatment: Drug: AeroLEF

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.

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 1V8
      • Queen Elizabeth II Health Sciences Centre, Capital Health
  • Ontario
    • Toronto, Ontario, Canada, M8V 2Z6
      • University Health Network, Toronto Western Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: Liposome-Encapsulated Fentanyl

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The primary efficacy variable is the time to effective analgesia following initiation of dosing with AeroLEF	Post operative period 12 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Time to first perceptible analgesic effect	Post-operative period 12 hours
Time and total of first rescue analgesic	Post-operative period 12 hours
Duration of effective analgesia	Post-operative period 12 hours
Pain rating scores	Post-operative period 12 hours
Adverse events	Post-operative period 12 hours

Collaborators and Investigators

• Sponsor: YM BioSciences
• Investigators: Principal Investigator: Vincent Chan, MD FRCPC, University Health Network, Toronto; Principal Investigator: Alexander John M Clark, MD FRCPC, Queen Elizabeth Ii Health Sciences Centre

Publications and helpful links

Helpful Links

• American Society of Anesthesiologists 2004 Annual Meeting, Abstract A-77
• American Pain Society 2008 Annual Meeting, Poster 264

Study record dates

Study Major Dates

• Study Start: February 1, 2004
• Primary Completion (Actual): June 1, 2004
• Study Completion (Actual): December 1, 2004

Study Registration Dates

• First Submitted: November 13, 2008
• First Submitted That Met QC Criteria: November 14, 2008
• First Posted (Estimate): November 17, 2008

Study Record Updates

• Last Update Posted (Estimate): November 17, 2008
• Last Update Submitted That Met QC Criteria: November 14, 2008
• Last Verified: November 1, 2008

More Information

Terms related to this study

• Keywords: Pain; Surgery; Fentanyl; Pain Control; Post Op pain
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Fentanyl
• Other Study ID Numbers: DLXLEF0