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

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.

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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 ]

Eligibility Criteria

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

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.

Contacts and Locations

Locations

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

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

More Information

Additional Information:

American Society of Anesthesiologists 2004 Annual Meeting, Abstract A-77 

American Pain Society 2008 Annual Meeting, Poster 264 

• Responsible Party: YM BioSciences Inc.., YM BioSciences
• ClinicalTrials.gov Identifier: NCT00791804
• Other Study ID Numbers: DLXLEF0
• First Posted: November 17, 2008
• Last Update Posted: November 17, 2008
• Last Verified: November 2008

Keywords provided by YM BioSciences:

Pain; Post Op pain; Fentanyl; Pain Control; Surgery

Additional relevant MeSH terms:

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