PainPhase 2NCT00286065
Study to Determine Efficacy and Safety of Inhaled AeroLEF in the Treatment of Acute Post-op Pain in Adult Patients Undergoing Elective Orthopedic Surgery
A Phase 2 study testing AeroLEF in people with Pain, run by YM BioSciences at 1 site in Canada.
Trial summary
The purpose of this study is to determine the effect of pain relief with AeroLEF in adult patients, following orthopedic surgery. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pain
- What is being tested?
- AeroLEF
- How many people
- 123 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2006to not given
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
The purpose of this study is to determine the effect of pain relief with AeroLEF in adult patients, following orthopedic surgery.
- Conditions
- Pain
- Being tested
- AeroLEF
- Keywords
- Pain, Fentanyl, Analgesics, Opioid, Inhalation
- Medical subject headings
- Pain, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AeroLEFDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
- 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
Secondary outcomes (7)
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2006 (estimated)
- Study startJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Enrolment
- 123 participants
Sponsor and investigators
- Lead sponsor
- YM BioSciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Vincent Chan, M.D., Principal investigator, University Health Network, TorontoKenneth Chisholm, M.D, Principal investigator, Queen Elizabeth II Infirmary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00286065
- Sponsor's protocol ID
- DLXLEF-AP4
- Status last verified
- Jun 2007
- First submitted
- 31 Jan 2006
- Last updated
- 27 Jun 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00286065
- Acronym / sponsor ID
- DLXLEF-AP4
- Conditions
- Pain
- Keywords
- Pain, Fentanyl, Analgesics, Opioid, Inhalation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants
- Lead sponsor
- YM BioSciencesIndustry (pharma, biotech, devices)
- Study start
- Jan 2006
- First posted
- 2 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the effect of pain relief with AeroLEF in adult patients, following orthopedic surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AeroLEF | Drug | – |
Primary outcome
- 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
7 secondary outcomes
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vincent Chan, M.D. principal investigator
University Health Network, Toronto
Kenneth Chisholm, M.D principal investigator
Queen Elizabeth II Infirmary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AeroLEF in people with Pain, run by YM BioSciences at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
- 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. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2007.