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

Pain Clinical Trial

— Pain  

Official title:

A Phase II Study Evaluating Inhaled AeroLEF(Liposome-Encapsulated Fentanyl 500mcg/mL)for Post-Operative Pain in Adults After ACL Knee Surgery.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00791804
• Other study ID #: DLXLEF0
• Status: Completed
• Phase: Phase 2
• First received: November 13, 2008
• Last updated: November 14, 2008
• Start date: February 2004
• Est. completion date: December 2004

Study information

• Verified date: November 2008
• Source: YM BioSciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: December 2004
• Est. primary completion date: June 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain
• Pain, Postoperative
• 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.

Locations

Country	Name	City	State
Canada	Queen Elizabeth II Health Sciences Centre, Capital Health	Halifax	Nova Scotia
Canada	University Health Network, Toronto Western Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
YM BioSciences

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary efficacy variable is the time to effective analgesia following initiation of dosing with AeroLEF		Post operative period 12 hours	Yes
Secondary	Time to first perceptible analgesic effect		Post-operative period 12 hours	Yes
Secondary	Time and total of first rescue analgesic		Post-operative period 12 hours	Yes
Secondary	Duration of effective analgesia		Post-operative period 12 hours	Yes
Secondary	Pain rating scores		Post-operative period 12 hours	Yes
Secondary	Adverse events		Post-operative period 12 hours	Yes

External Links

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