Safety and Efficacy of Methoxyflurane for Treatment of In... | NCT00524927

Studies
Safety and Efficacy of Methoxyflurane for Treatment of Incident Pain

NCT00524927

Sponsor

Medical Developments International Limited

Status

Completed

Last Update Posted

Jan 28, 2010Estimated

Enrollment

110Estimated

Phase

Phase 4

Conditions

Pain Measurement

Interventions

Methoxyflurane
Normal Saline

Countries

Australia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2007

Primary Completion Date

Not provided

Completion Date

Nov 2009Actual

First Submitted Date

Sep 2, 2007

First Submission Date that Met QC Criteria

Sep 2, 2007

First Posted Date

Sep 5, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 27, 2010

Last Update Posted Date

Jan 28, 2010Estimated

Name	Class
Australian Department of Industry, Tourism and Resources	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

110Estimated

Label	Type	Description	Intervention Names
A	Active Comparator		Drug: Methoxyflurane
B	Placebo Comparator		Drug: Normal Saline

Name	Type	Description	Arm Group Labels	Other Names
Methoxyflurane	Drug		A
Normal Saline

Measure	Description	Time Frame
Determine where there is a difference in efficacy between Methoxyflurane and placebo for control of pain in participants undergoing a Bone Marrow Biopsy

Measure	Description	Time Frame
Determine the safety of Methoxyflurane

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Odette Spruyt, MD	Peter MacCallum Cancer Centre, Australia	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Peter MacCallum Cancer Centre		Melbourne	Victoria	3002	Australia

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24644183	Derived	Spruyt O, Westerman D, Milner A, Bressel M, Wein S. A randomised, double-blind, placebo-controlled study to assess the safety and efficacy of methoxyflurane for procedural pain of a bone marrow biopsy. BMJ Support Palliat Care. 2014 Dec;4(4):342-8. doi: 10.1136/bmjspcare-2013-000447. Epub 2013 Jun 7.

ID	Term
D008733	Methoxyflurane
D000077330	Saline Solution

ID	Term
D005019	Ethyl Ethers
D004987	Ethers
D009930	Organic Chemicals
D008738	Methyl Ethers