Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 10:39 PM
Study NCT ID:
NCT00525967
Status:
UNKNOWN
Last Update Posted:
2007-09-06
First Post:
2007-09-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Switching From Morphine to Oral Methadone Plus Acetaminophen in the Treatment of Cancer Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2013-04-22', 'releaseDate': '2013-03-10'}], 'estimatedResultsFirstSubmitDate': '2013-03-10'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D000072716', 'term': 'Cancer Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008691', 'term': 'Methadone'}, {'id': 'D000082', 'term': 'Acetaminophen'}], 'ancestors': [{'id': 'D007659', 'term': 'Ketones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2006-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-09', 'completionDateStruct': {'date': '2007-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2007-09-05', 'studyFirstSubmitDate': '2007-09-05', 'studyFirstSubmitQcDate': '2007-09-05', 'lastUpdatePostDateStruct': {'date': '2007-09-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-09-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain intensity and time to equianalgesic effect', 'timeFrame': 'within the first 7 days after switching'}], 'secondaryOutcomes': [{'measure': 'Degree of nausea, vomiting, obstipation, xerostomia and drowsiness', 'timeFrame': 'within the first 7 days of switching'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cancer Pain', 'Methadone', 'Morphine', 'Acetaminophen', 'Palliative Care'], 'conditions': ['Cancer', 'Pain', 'Palliative Care']}, 'referencesModule': {'references': [{'pmid': '9779694', 'type': 'RESULT', 'citation': 'Ripamonti C, Groff L, Brunelli C, Polastri D, Stavrakis A, De Conno F. Switching from morphine to oral methadone in treating cancer pain: what is the equianalgesic dose ratio? J Clin Oncol. 1998 Oct;16(10):3216-21. doi: 10.1200/JCO.1998.16.10.3216.'}, {'pmid': '11387363', 'type': 'RESULT', 'citation': 'Mercadante S, Casuccio A, Fulfaro F, Groff L, Boffi R, Villari P, Gebbia V, Ripamonti C. Switching from morphine to methadone to improve analgesia and tolerability in cancer patients: a prospective study. J Clin Oncol. 2001 Jun 1;19(11):2898-904. doi: 10.1200/JCO.2001.19.11.2898.'}, {'pmid': '10506634', 'type': 'RESULT', 'citation': 'Mercadante S, Casuccio A, Calderone L. Rapid switching from morphine to methadone in cancer patients with poor response to morphine. J Clin Oncol. 1999 Oct;17(10):3307-12. doi: 10.1200/JCO.1999.17.10.3307.'}, {'pmid': '16051965', 'type': 'RESULT', 'citation': 'Mercadante S, Ferrera P, Villari P, Casuccio A. Rapid switching between transdermal fentanyl and methadone in cancer patients. J Clin Oncol. 2005 Aug 1;23(22):5229-34. doi: 10.1200/JCO.2005.13.128.'}, {'pmid': '14701781', 'type': 'RESULT', 'citation': 'Bruera E, Palmer JL, Bosnjak S, Rico MA, Moyano J, Sweeney C, Strasser F, Willey J, Bertolino M, Mathias C, Spruyt O, Fisch MJ. Methadone versus morphine as a first-line strong opioid for cancer pain: a randomized, double-blind study. J Clin Oncol. 2004 Jan 1;22(1):185-92. doi: 10.1200/JCO.2004.03.172.'}, {'pmid': '15310785', 'type': 'RESULT', 'citation': 'Stockler M, Vardy J, Pillai A, Warr D. Acetaminophen (paracetamol) improves pain and well-being in people with advanced cancer already receiving a strong opioid regimen: a randomized, double-blind, placebo-controlled cross-over trial. J Clin Oncol. 2004 Aug 15;22(16):3389-94. doi: 10.1200/JCO.2004.09.122.'}, {'pmid': '9817288', 'type': 'RESULT', 'citation': 'Mercadante S, Casuccio A, Agnello A, Serretta R, Calderone L, Barresi L. Morphine versus methadone in the pain treatment of advanced-cancer patients followed up at home. J Clin Oncol. 1998 Nov;16(11):3656-61. doi: 10.1200/JCO.1998.16.11.3656.'}], 'seeAlsoLinks': [{'url': 'http://www.palliativedrugs.com', 'label': 'Newsletter, March 2004'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether oral methadone plus acetaminophen can substitute morphine in the treatment of cancer pain.', 'detailedDescription': 'Opioids are the mainstay of moderate-to-severe cancer pain management. Although morphine is the most commonly used, methadone has some advantages such as higher potency, lower cost and longer administration intervals. To minimize the time necessary to achieve the equianalgesic effect after a switching from morphine to methadone, acetaminophen was added in the treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of cancer pain\n* Regular use of oral Morphine\n\nExclusion Criteria:\n\n* Use of Acetaminophen in the last 48 hours\n* Renal or Hepatic failure'}, 'identificationModule': {'nctId': 'NCT00525967', 'briefTitle': 'Switching From Morphine to Oral Methadone Plus Acetaminophen in the Treatment of Cancer Pain', 'organization': {'class': 'OTHER', 'fullName': 'Faculdade de Medicina do ABC'}, 'officialTitle': 'Switching From Morphine to Oral Methadone Plus Acetaminophen in the Treatment of Cancer Pain: A Randomized, Double-Blind Study', 'orgStudyIdInfo': {'id': '217/2005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Methadone plus Placebo', 'interventionNames': ['Drug: Methadone plus Acetaminophen or Placebo']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Methadone plus Acetaminophen', 'interventionNames': ['Drug: Methadone plus Acetaminophen or Placebo']}], 'interventions': [{'name': 'Methadone plus Acetaminophen or Placebo', 'type': 'DRUG', 'description': 'Methadone bid according to a established conversion morphine-to-methadone ratio plus Placebo or Acetaminophen qid', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '09060-650', 'city': 'Santo André', 'state': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Auro del Giglio, Professor', 'role': 'CONTACT', 'email': 'sandrabr@netpoint.com.br', 'phone': '55-11-49935491'}, {'name': 'Daniel IG Cubero, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Disciplina de Oncologia, Faculdade de Medicina do ABC', 'geoPoint': {'lat': -23.66389, 'lon': -46.53833}}], 'centralContacts': [{'name': 'Daniel IG Cubero, MD', 'role': 'CONTACT', 'email': 'danielcubero@uol.com.br', 'phone': '55-11-81799103'}], 'overallOfficials': [{'name': 'Daniel IG Cubero', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculdade de Medicina do ABC'}, {'name': 'Auro del Giglio', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Faculdade de Medicina do ABC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Faculdade de Medicina do ABC', 'class': 'OTHER'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2013-03-10', 'type': 'RELEASE'}, {'date': '2013-04-22', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Daniel de Iracema Gomes Cubero, Principal Investigator, Faculdade de Medicina do ABC'}}}}