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

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ClinicalTrials.gov Identifier: NCT00791804
Recruitment Status : Completed
First Posted : November 17, 2008
Last Update Posted : November 17, 2008
Sponsor:
Information provided by:
YM BioSciences

Tracking Information
First Submitted Date  ICMJE November 13, 2008
First Posted Date  ICMJE November 17, 2008
Last Update Posted Date November 17, 2008
Study Start Date  ICMJE February 2004
Actual Primary Completion Date June 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 14, 2008)
The primary efficacy variable is the time to effective analgesia following initiation of dosing with AeroLEF [ Time Frame: Post operative period 12 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 14, 2008)
  • Time to first perceptible analgesic effect [ Time Frame: Post-operative period 12 hours ]
  • Time and total of first rescue analgesic [ Time Frame: Post-operative period 12 hours ]
  • Duration of effective analgesia [ Time Frame: Post-operative period 12 hours ]
  • Pain rating scores [ Time Frame: Post-operative period 12 hours ]
  • Adverse events [ Time Frame: Post-operative period 12 hours ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase II Study of Inhaled AeroLEF for Analgesia After ACL Knee Surgery
Official Title  ICMJE A Phase II Study Evaluating Inhaled AeroLEF(Liposome-Encapsulated Fentanyl 500mcg/mL)for Post-Operative Pain in Adults After ACL Knee Surgery.
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Pain
  • Post Operative Pain
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: Single Arm
Intervention: Drug: AeroLEF
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 14, 2008)
19
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2004
Actual Primary Completion Date June 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00791804
Other Study ID Numbers  ICMJE DLXLEF0
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party YM BioSciences Inc.., YM BioSciences
Study Sponsor  ICMJE YM BioSciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Vincent Chan, MD FRCPC University Health Network, Toronto
Principal Investigator: Alexander John M Clark, MD FRCPC Queen Elizabeth II Health Sciences Centre
PRS Account YM BioSciences
Verification Date November 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP