Ignite Creation Date:
2025-12-25 @ 5:09 AM
Ignite Modification Date:
2025-12-26 @ 4:13 AM
Study NCT ID:
NCT00524927
Status:
COMPLETED
Last Update Posted:
2010-01-28
First Post:
2007-09-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Methoxyflurane for Treatment of Incident Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008733', 'term': 'Methoxyflurane'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D005019', 'term': 'Ethyl Ethers'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D008738', 'term': 'Methyl Ethers'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 110}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-01', 'completionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-01-27', 'studyFirstSubmitDate': '2007-09-02', 'studyFirstSubmitQcDate': '2007-09-02', 'lastUpdatePostDateStruct': {'date': '2010-01-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-09-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determine where there is a difference in efficacy between Methoxyflurane and placebo for control of pain in participants undergoing a Bone Marrow Biopsy'}], 'secondaryOutcomes': [{'measure': 'Determine the safety of Methoxyflurane'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Incident Pain', 'Bone Marrow Biopsy'], 'conditions': ['Pain Measurement']}, 'referencesModule': {'references': [{'pmid': '24644183', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adult participants (18 years of age or older)\n* Able to give written informed consent\n* Anticipated episode(s) of incident pain related to planned BMB lasting no more than 30 minutes on average\n* Anticipated life expectancy of at least 1 month\n\nPre-Exclusion Criteria:\n\n* 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\n* 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\n* Concomitant use of other investigational agents\n* Concomitant use of nephrotoxic agents such as gentamicin\n* Uncontrolled INR (\\>4)\n* Personal or familial hypersensitivity to fluorinated anaesthetics\n* Personal or familial malignant hyperthermia\n* Respiratory rate of less than 10 per minute\n* Has previously received methoxyflurane\n* Known pre-existing renal or hepatic impairment\n* Compromised Renal Function (creatinine ≥ 1.5 x ULNR)\n* Compromised Liver Function (bilirubin ≥ 2.5 x ULNR)\n\nExclusion Criteria:\n\n* Premedication with anxiolytic (e.g. midazolam, diazepam)\n* Dosed with breakthrough dose of analgesic that may contribute to control of pain during the planned procedure"}, 'identificationModule': {'nctId': 'NCT00524927', 'briefTitle': 'Safety and Efficacy of Methoxyflurane for Treatment of Incident Pain', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medical Developments International Limited'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '06/61'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'A', 'interventionNames': ['Drug: Methoxyflurane']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'B', 'interventionNames': ['Drug: Normal Saline']}], 'interventions': [{'name': 'Methoxyflurane', 'type': 'DRUG', 'armGroupLabels': ['A']}, {'name': 'Normal Saline', 'type': 'DRUG', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3002', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Peter MacCallum Cancer Centre', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}], 'overallOfficials': [{'name': 'Odette Spruyt, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peter MacCallum Cancer Centre, Australia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical Developments International Limited', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Australian Department of Industry, Tourism and Resources', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Greg Plunkett, Regulatory Affairs Manager', 'oldOrganization': 'Medical Developments International'}}}}