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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: YM BioSciences

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.