Study to Determine Efficacy and Safety of Inhaled AeroLEF in the Treatment of Acute Post-op Pain in Adult Patients Undergoing Elective Orthopedic Surgery

NCT ID: NCT00286065

Last Updated: 2007-06-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 123 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-31

Brief Summary

The purpose of this study is to determine the effect of pain relief with AeroLEF in adult patients, following orthopedic surgery.

Conditions

Pain

Keywords

Pain; Fentanyl; Analgesics; Opioid; Inhalation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

AeroLEF

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• male and female 18 to 70 years
• patient alert and capable of self-administering an opioid anaglesic
• Patient is scheduled for orthopedic surgery under general anesthesia
• Patient has normal laboratory values
• Physical examination with no clincially relevant findings
• Patient in general good health based on medical history and clincially acceptable
• Patient is able to understand the requirements of the study
• Patient is able to communicate effectively with study personnel _Patient voluntarily gives written approval.

Exclusion Criteria

• During Part 2 (randomized period) which involves the use of placebo, patients who are undergoing a major orthopedic procedure that normally requires multimodal analgesia to achieve adequate postoperative pain control (e.g. major spine surgery, total knee arthoplasty) will be excluded.
• Patient is taking opioid or non-opioid analgesics on a chronic basis at doses which in the opinion of the investigator would interfere with evaluations of post-operative fentanyl efficacy.
• History of pulmonary, cardiovascular, neurologic, endocrine, hepatic, gastrointestinal (GI), or kidney disease or therapy that would jeopardize the patient's well-being by participation in this study.
• Patient has documented or self-reported medical history of sleep apnea.
• Patient has a documented hypersensitivity to fentanyl or other opioid analgesics.
• Patient has a documented hypersensitivity/allergy to the components of the liposomes used in the AeroLEF formulation, including hypersensitivity to soya lecithin or related food products such as soya bean and peanut.
• Patient is currently receiving treatment, or has received treatment in the previous two weeks, with monoamine oxidase inhibitors.
• Patient has a history of malignancy within the past 5 years, with the exception of successfully treated non?metastatic basal cell or squamous cell carcinomas of the skin and/or localized carcinoma in situ of the cervix.
• Patient was dosed with another investigational drug within 30 days prior to the Screening Visit.
• Patient has current therapy with CNS-depressant medications (other than stable doses of analgesics and drugs used with surgical anesthesia).
• Patient has current evidence of alcohol abuse (regularly drinks more than 4 units of alcohol per day; 1 unit = ½ pint of beer, 1 glass of wine, or 1 ounce of spirit).
• Patient has a history of abuse of licit or illicit drug substances.
• Patient, who in the opinion of the Investigator, is mentally or emotionally unsuitable to participate, or unable/unwilling to comply with the study assessments.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

YM BioSciences

INDUSTRY

Sponsor Role: lead

Principal Investigators

Vincent Chan, M.D.

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Kenneth Chisholm, M.D

Role: PRINCIPAL_INVESTIGATOR

Queen Elizabeth II Infirmary

Locations

Toronto Western Hospital

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

DLXLEF-AP4

Identifier Type: -

Identifier Source: org_study_id