- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00524927
Safety and Efficacy of Methoxyflurane for Treatment of Incident Pain
January 27, 2010 updated by: Medical Developments International Limited
A Phase IV, Randomized, Double Blind, Single Centre, Placebo Controlled Study to Assess the Safety and Efficacy of Methoxyflurane [Penthrox] for the Treatment of Incident Pain in Participants Undergoing a Bone Marrow Biopsy Procedure
This study aims to provide further supportive evidence that Methoxyflurane, a potent analgesic, administered using the Penthrox Inhaler is safe and efficacious in adult participants, specifically those who experience incident pain associated with a planned bone marrow biopsy.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
110
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Victoria
-
Melbourne, Victoria, Australia, 3002
- Peter Maccallum Cancer Centre
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Adult participants (18 years of age or older)
- Able to give written informed consent
- Anticipated episode(s) of incident pain related to planned BMB lasting no more than 30 minutes on average
- Anticipated life expectancy of at least 1 month
Pre-Exclusion Criteria:
- Subjects with a clinical condition that may, in the opinion of the investigator, impact on the subject's ability to participate in the study, or on the study results
- Participants who have had IV sedation/opioid on previous BMB and who wish to receive IV sedation/opioid on this occasion or who in the opinion of the BMB operator would be advised to receive IV sedation/opioid on this occasion
- Concomitant use of other investigational agents
- Concomitant use of nephrotoxic agents such as gentamicin
- Uncontrolled INR (>4)
- Personal or familial hypersensitivity to fluorinated anaesthetics
- Personal or familial malignant hyperthermia
- Respiratory rate of less than 10 per minute
- Has previously received methoxyflurane
- Known pre-existing renal or hepatic impairment
- Compromised Renal Function (creatinine ≥ 1.5 x ULNR)
- Compromised Liver Function (bilirubin ≥ 2.5 x ULNR)
Exclusion Criteria:
- Premedication with anxiolytic (e.g. midazolam, diazepam)
- Dosed with breakthrough dose of analgesic that may contribute to control of pain during the planned procedure
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: A
|
|
Placebo Comparator: B
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Determine where there is a difference in efficacy between Methoxyflurane and placebo for control of pain in participants undergoing a Bone Marrow Biopsy
|
Secondary Outcome Measures
Outcome Measure |
---|
Determine the safety of Methoxyflurane
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Odette Spruyt, MD, Peter MacCallum Cancer Centre, Australia
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2007
Study Completion (Actual)
November 1, 2009
Study Registration Dates
First Submitted
September 2, 2007
First Submitted That Met QC Criteria
September 2, 2007
First Posted (Estimate)
September 5, 2007
Study Record Updates
Last Update Posted (Estimate)
January 28, 2010
Last Update Submitted That Met QC Criteria
January 27, 2010
Last Verified
January 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 06/61
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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