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

• ClinicalTrials.gov Identifier: NCT00791804
• Recruitment Status: Completed
• First Posted: November 17, 2008
• Last Update Posted: November 17, 2008
• Sponsor: YM BioSciences
• Information provided by: YM BioSciences

Tracking Information

• First Submitted Date: November 13, 2008
• First Posted Date: November 17, 2008
• Last Update Posted Date: November 17, 2008
• Study Start Date: February 2004
• Actual Primary Completion Date: June 2004 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: November 14, 2008): The primary efficacy variable is the time to effective analgesia following initiation of dosing with AeroLEF [ Time Frame: Post operative period 12 hours ]
• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: November 14, 2008)

• 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 ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Phase II Study of Inhaled AeroLEF for Analgesia After ACL Knee Surgery
• Official Title: A Phase II Study Evaluating Inhaled AeroLEF(Liposome-Encapsulated Fentanyl 500mcg/mL)for Post-Operative Pain in Adults After ACL Knee Surgery.
• 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.
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Pain
• Post Operative Pain

Intervention

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

Study Arms

Experimental: Single Arm

Intervention: Drug: AeroLEF

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 14, 2008): 19
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: December 2004
• Actual Primary Completion Date: June 2004 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada

Administrative Information

• NCT Number: NCT00791804
• Other Study ID Numbers: DLXLEF0
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: YM BioSciences Inc.., YM BioSciences
• Study Sponsor: YM BioSciences
• Collaborators: Not Provided

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

• PRS Account: YM BioSciences
• Verification Date: November 2008