PainPhase 2PainNCT00791804
Phase II Study of Inhaled AeroLEF for Analgesia After ACL Knee Surgery
A Phase 2 study testing AeroLEF in people with Pain and Post Operative Pain, run by YM BioSciences at 2 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Pain, Post Operative Pain
- What is being tested?
- AeroLEF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 2 sitesCanada
- Study dates
- Feb 2004to Dec 2004
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female between ages 18 years and 60 years.
- A body mass index of between 18 and 30, inclusive.
- If a female of child-bearing potential, the patient must have a negative urine pregnancy test at screening and baseline.
- 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.
- Scheduled for a morning surgery and anticipating remaining in the hospital for an overnight stay.
- 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 .
- Physical examination with no clinically relevant findings as determined by the investigator.
- 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.
Who cannot join
- History of addiction to drugs or alcohol.
- Exposure to any investigational drug within the 30 days prior to enrolment.
- Documented hypersensitivity to fentanyl or other opioid analgesics
- Documented hypersensitivity/allergy to the components of the liposomes used in the AeroLEF formulation
- 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)
- Currently receiving treatment, or have received treatment in the previous two weeks, with antidepressant or antipsychotic drugs (including monoamine oxidase inhibitors).
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- Clinically significant ongoing medical conditions.
- Currently receiving treatment for chronic pain.
- Current therapy with narcotic or CNS-depressant medications.
- Current chronic therapy with NSAIDs, ASA or acetaminophen within the previous 7 days.
- Patient, who in the opinion of the investigator, is mentally or emotionally unsuitable to participate, or unable/unwilling to comply with the study assessments.
- Blood donation or other blood loss within 45 days prior to enrolment in the study totalling 100 mL or greater.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Queen Elizabeth II Health Sciences Centre, Capital Health
Halifax, Nova Scotia, B3H 1V8
University Health Network, Toronto Western Hospital
Toronto, Ontario, M8V 2Z6
About this study
Official title: A Phase II Study Evaluating Inhaled AeroLEF(Liposome-Encapsulated Fentanyl 500mcg/mL)for Post-Operative Pain in Adults After ACL Knee Surgery.
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.
Read the 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.
- Conditions
- Pain, Post Operative Pain
- Being tested
- AeroLEF
- Keywords
- Pain, Post Op pain, Fentanyl, Pain Control, Surgery
- Medical subject headings
- Pain, Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AeroLEFDrug
Also called Liposome-Encapsulated Fentanyl
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.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | Not described Receives: Drug: AeroLEF |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy variable is the time to effective analgesia following initiation of dosing with AeroLEF
Measured: Post operative period 12 hours
Secondary outcomes (5)
Time to first perceptible analgesic effect
Measured: Post-operative period 12 hours
Time and total of first rescue analgesic
Measured: Post-operative period 12 hours
Duration of effective analgesia
Measured: Post-operative period 12 hours
Pain rating scores
Measured: Post-operative period 12 hours
Adverse events
Measured: Post-operative period 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2008 (estimated)
- Study startFeb 2004
- Primary completionJun 2004
- Study completionDec 2004
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- YM BioSciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Vincent Chan, MD FRCPC, Principal investigator, University Health Network, TorontoAlexander John M Clark, MD FRCPC, Principal investigator, Queen Elizabeth II Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00791804
- Sponsor's protocol ID
- DLXLEF0
- Acronym
- Pain
- Status last verified
- Nov 2008
- First submitted
- 13 Nov 2008
- Last updated
- 17 Nov 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study Evaluating Inhaled AeroLEF(Liposome-Encapsulated Fentanyl 500mcg/mL)for Post-Operative Pain in Adults After ACL Knee Surgery.
- ClinicalTrials.gov ID
- NCT00791804
- Acronym / sponsor ID
- Pain / DLXLEF0
- Conditions
- Pain, Post Operative Pain
- Keywords
- Pain, Post Op pain, Fentanyl, Pain Control, Surgery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- YM BioSciencesIndustry (pharma, biotech, devices)
- Study start
- Feb 2004
- Primary completion
- Jun 2004 (actual)
- Study completion
- Dec 2004 (actual)
- First posted
- 17 Nov 2008 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Drug: AeroLEF |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Male or female between ages 18 years and 60 years.
- A body mass index of between 18 and 30, inclusive.
- If a female of child-bearing potential, the patient must have a negative urine pregnancy test at screening and baseline.
- 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.
- Scheduled for a morning surgery and anticipating remaining in the hospital for an overnight stay.
Key exclusion criteria (12 listed)
- History of addiction to drugs or alcohol.
- Exposure to any investigational drug within the 30 days prior to enrolment.
- Documented hypersensitivity to fentanyl or other opioid analgesics
- Documented hypersensitivity/allergy to the components of the liposomes used in the AeroLEF formulation
- 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)
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 |
|---|---|---|
| AeroLEFAlso: Liposome-Encapsulated FentanylInhaled 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. | Drug | Single Arm |
Primary outcome
The primary efficacy variable is the time to effective analgesia following initiation of dosing with AeroLEF
Time frame: Post operative period 12 hours
5 secondary outcomes
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
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 17 Nov 2008.
- American Society of Anesthesiologists 2004 Annual Meeting, Abstract A-77Link provided by the sponsor.
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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, MD FRCPC principal investigator
University Health Network, Toronto
Alexander John M Clark, MD FRCPC principal investigator
Queen Elizabeth II Health Sciences Centre
2 sites 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 and Post Operative Pain, run by YM BioSciences at 2 sites 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 12 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 17 Nov 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The primary efficacy variable is the time to effective analgesia following initiation of dosing with AeroLEF (time frame: Post operative period 12 hours). 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 17 Nov 2008.