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

This study has been completed.
Sponsor:
Information provided by:
YM BioSciences
ClinicalTrials.gov Identifier:
NCT00791804
First received: November 13, 2008
Last updated: November 14, 2008
Last verified: November 2008
  Purpose

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 Intervention Phase
Pain
Post Operative Pain
Drug: AeroLEF
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by YM BioSciences:

Primary Outcome Measures:
  • The primary efficacy variable is the time to effective analgesia following initiation of dosing with AeroLEF [ Time Frame: Post operative period 12 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Time to first perceptible analgesic effect [ Time Frame: Post-operative period 12 hours ] [ Designated as safety issue: Yes ]
  • Time and total of first rescue analgesic [ Time Frame: Post-operative period 12 hours ] [ Designated as safety issue: Yes ]
  • Duration of effective analgesia [ Time Frame: Post-operative period 12 hours ] [ Designated as safety issue: Yes ]
  • Pain rating scores [ Time Frame: Post-operative period 12 hours ] [ Designated as safety issue: Yes ]
  • Adverse events [ Time Frame: Post-operative period 12 hours ] [ Designated as safety issue: Yes ]

Enrollment: 19
Study Start Date: February 2004
Study Completion Date: December 2004
Primary Completion Date: June 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00791804

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:
No publications provided

Responsible Party: YM BioSciences Inc.., YM BioSciences
ClinicalTrials.gov Identifier: NCT00791804     History of Changes
Other Study ID Numbers: DLXLEF0
Study First Received: November 13, 2008
Last Updated: November 14, 2008
Health Authority: Canada: Health Canada

Keywords provided by YM BioSciences:
Pain
Post Op pain
Fentanyl
Pain Control
Surgery

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Pathologic Processes
Postoperative Complications
Signs and Symptoms
Fentanyl
Adjuvants, Anesthesia
Analgesics
Analgesics, Opioid
Anesthetics
Anesthetics, General
Anesthetics, Intravenous
Central Nervous System Agents
Central Nervous System Depressants
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014