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

NCT00791804 | Completed Phase 2

• 1 other identifier: DLXLEF0
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 2

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.

Conditions

Pain; Post Operative Pain

Keywords

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

Outcome Measures

Primary Outcomes (1)

• The primary efficacy variable is the time to effective analgesia following initiation of dosing with AeroLEF

  Post operative period 12 hours

Secondary Outcomes (5)

• 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

Study Arms (1)

Single Arm

EXPERIMENTAL

Drug: AeroLEF

Interventions

AeroLEF DRUG

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.

Also known as: Liposome-Encapsulated Fentanyl

Single Arm

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• YM BioSciences: lead

Study Sites (2)

Queen Elizabeth II Health Sciences Centre, Capital Health

Halifax, Nova Scotia, B3H 1V8, Canada

Location

University Health Network, Toronto Western Hospital

Toronto, Ontario, M8V 2Z6, Canada

Location

Related Links

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

MeSH Terms

Conditions

Pain; Pain, Postoperative; Agnosia

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Vincent Chan, MD FRCPC

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

• Alexander John M Clark, MD FRCPC

  Queen Elizabeth II Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 13, 2008
• First Posted: November 17, 2008
• Study Start: February 1, 2004
• Primary Completion: June 1, 2004
• Study Completion: December 1, 2004
• Last Updated: November 17, 2008

Record last verified: 2008-11

Locations

CA (2)