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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00286065
Recruitment Status : Completed
First Posted : February 2, 2006
Last Update Posted : June 27, 2007
Sponsor:
Information provided by:
YM BioSciences

Tracking Information
First Submitted Date  ICMJE January 31, 2006
First Posted Date  ICMJE February 2, 2006
Last Update Posted Date June 27, 2007
Study Start Date  ICMJE January 2006
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: August 15, 2006)
- Summed Pain Relief plus Pain Intensity Difference (SPRID) scores during the interval from Baseline post-surgery to 4 hours after the initial dose following surgery
Original Primary Outcome Measures  ICMJE
 (submitted: January 31, 2006)
· Summed Pain Relief plus Pain Intensity Difference (SPRID) scores during the interval from Baseline post-surgery to 4 hours after the initial dose following surgery
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 15, 2006)
  • Sum of the Pain Intensity Difference scores (SPID) for 4 hours after the start of the initial dose
  • Sum of the Pain Relief scores (TOTPAR) for the 4 hours following the start of the initial dose
  • Total use of rescue analgesic drug.
  • Time to effective pain relief (measured by stopwatch).
  • Duration of effective pain relief as measured by the interval between time to onset of effective pain relief and time to first use of rescue drug (both measured by stopwatch) or next dose of study drug.
  • Clinician Global Impression (CGI) scores at 4 and 12 hours after the start of the initial post-surgery dose of study drug.
  • Patient Treatment Satisfaction Rating scores at 4 and 12 hours after the start of the initial post-surgery dose of study drug.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 31, 2006)
  • · Sum of the Pain Intensity Difference scores (SPID) for 4 hours after the start of the initial dose
  • · Sum of the Pain Relief scores (TOTPAR) for the 4 hours following the start of the initial dose
  • · Total use of rescue analgesic drug.
  • · Time to effective pain relief (measured by stopwatch).
  • · Duration of effective pain relief as measured by the interval between time to onset of effective pain relief and time to first use of rescue drug (both measured by stopwatch) or next dose of study drug.
  • · Clinician Global Impression (CGI) scores at 4 and 12 hours after the start of the initial post-surgery dose of study drug.
  • · Patient Treatment Satisfaction Rating scores at 4 and 12 hours after the start of the initial post-surgery dose of study drug.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Determine Efficacy and Safety of Inhaled AeroLEF in the Treatment of Acute Post-op Pain in Adult Patients Undergoing Elective Orthopedic Surgery
Official Title  ICMJE Multi-Centre Placebo-Controlled Randomized 2 Part Study to Determine Efficacy and Safety of Inhaled AeroLEF in the Treatment of Acute Post-Op Pain in Adult Patients Undergoing Elective Orthopedic Surgery
Brief Summary The purpose of this study is to determine the effect of pain relief with AeroLEF in adult patients, following orthopedic surgery.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Pain
Intervention  ICMJE Drug: AeroLEF
Study Arms  ICMJE Not Provided
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
Enrollment  ICMJE
 (submitted: January 31, 2006)
123
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older 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 NCT00286065
Other Study ID Numbers  ICMJE DLXLEF-AP4
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE YM BioSciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Vincent Chan, M.D. University Health Network, Toronto
Principal Investigator: Kenneth Chisholm, M.D Queen Elizabeth II Infirmary
PRS Account YM BioSciences
Verification Date June 2007

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