Ignite Creation Date:
2025-12-24 @ 12:05 PM
Ignite Modification Date:
2025-12-27 @ 10:47 PM
Study NCT ID:
NCT00365261
Status:
COMPLETED
Last Update Posted:
2016-07-11
First Post:
2006-08-15
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of Eszopiclone on Sleep Disturbance and Pain in Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D005221', 'term': 'Fatigue'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069582', 'term': 'Eszopiclone'}], 'ancestors': [{'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011719', 'term': 'Pyrazines'}, {'id': 'D011725', 'term': 'Pyridines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jdimsdale@ucsd.edu', 'phone': '619 543-5592', 'title': 'Joel Dimsdale, M.D., Principal Investigator', 'organization': 'University of California, San Diego'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Eszopiclone', 'description': 'receipt of active drug', 'otherNumAtRisk': 23, 'otherNumAffected': 3, 'seriousNumAtRisk': 23, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'receipt of placebo', 'otherNumAtRisk': 22, 'otherNumAffected': 3, 'seriousNumAtRisk': 22, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'fatigue', 'notes': 'fatigue or drowsiness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Eszopiclone', 'description': 'active drug'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '3.72', 'spread': '0.38', 'groupId': 'OG000'}, {'value': '5.41', 'spread': '0.47', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'post dosing', 'description': 'Pain was assessed with a 10-cm visual analog scale (0 = "no pain at all"; 10 = "severe, uncontrolled pain").', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Patient Self-report Data on Fatigue', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Eszopiclone', 'description': 'active drug\n\nEszopiclone: eszopiclone 2 to 3 mg po at bedtime'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'placebo\n\nPlacebo: placebo 2 to 3 mg po at bedtime'}], 'classes': [{'categories': [{'measurements': [{'value': '2.41', 'spread': '0.20', 'groupId': 'OG000'}, {'value': '2.77', 'spread': '0.17', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 days post treatment', 'description': 'Patients completed the five-item Profile of Mood States Scale, Short Form (POMS-SF) Fatigue-Inertia Scale to rate their fatigue complaints (scores range from 0 to 28; higher scores denote more fatigue).', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Opiate Dosing From Patient Controlled Analgesia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Eszopiclone', 'description': 'active drug'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '36.35', 'groupId': 'OG000', 'lowerLimit': '17.57', 'upperLimit': '58.46'}, {'value': '40.94', 'groupId': 'OG001', 'lowerLimit': '23.37', 'upperLimit': '66.19'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '2 days post dosing', 'description': 'Morphine or dilaudid dose delivered at fixed rate with optional self-administered prn boluses. Dilaudid doses were converted into morphine equivalents by multiplying the dose by 5.', 'unitOfMeasure': 'mg', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Eszopiclone', 'description': 'receipt of active drug'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'receipt of placebo'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Eszopiclone', 'description': 'receipt of active drug'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'receipt of placebo'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '45.52', 'spread': '13.06', 'groupId': 'BG000'}, {'value': '46', 'spread': '15.86', 'groupId': 'BG001'}, {'value': '45.76', 'spread': '14.33', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-03', 'studyFirstSubmitDate': '2006-08-15', 'resultsFirstSubmitDate': '2011-08-24', 'studyFirstSubmitQcDate': '2006-08-15', 'lastUpdatePostDateStruct': {'date': '2016-07-11', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-08-24', 'studyFirstPostDateStruct': {'date': '2006-08-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-09-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain', 'timeFrame': 'post dosing', 'description': 'Pain was assessed with a 10-cm visual analog scale (0 = "no pain at all"; 10 = "severe, uncontrolled pain").'}, {'measure': 'Patient Self-report Data on Fatigue', 'timeFrame': '2 days post treatment', 'description': 'Patients completed the five-item Profile of Mood States Scale, Short Form (POMS-SF) Fatigue-Inertia Scale to rate their fatigue complaints (scores range from 0 to 28; higher scores denote more fatigue).'}], 'secondaryOutcomes': [{'measure': 'Opiate Dosing From Patient Controlled Analgesia', 'timeFrame': '2 days post dosing', 'description': 'Morphine or dilaudid dose delivered at fixed rate with optional self-administered prn boluses. Dilaudid doses were converted into morphine equivalents by multiplying the dose by 5.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['pain', 'fatigue', 'sleep', 'bone marrow transplant', 'cancer'], 'conditions': ['Sleep Initiation and Maintenance Disorders']}, 'referencesModule': {'references': [{'pmid': '21116652', 'type': 'RESULT', 'citation': 'Dimsdale JE, Ball ED, Carrier E, Wallace M, Holman P, Mulroney C, Shaikh F, Natarajan L. Effect of eszopiclone on sleep, fatigue, and pain in patients with mucositis associated with hematologic malignancies. Support Care Cancer. 2011 Dec;19(12):2015-20. doi: 10.1007/s00520-010-1052-1. Epub 2010 Nov 30.'}]}, 'descriptionModule': {'briefSummary': 'To assess the effectiveness of Lunesta on cancer patients who have received chemotherapy and who require patient controlled analgesia (PCA), specifically to assess whether Lunesta will:\n\n* improve sleep thereby decreasing need for opiates via PCA\n* improve sleep thereby decreasing pain by self report\n* improve sleep thereby decreasing fatigue by self report', 'detailedDescription': 'Pain and fatigue are the most common symptom complaints of cancer patients. Although dramatic improvements have come about in recognizing and treating cancer related pain, less progress has been made in treating fatigue. Interventions to improve sleep may offer benefit in terms of pain and fatigue.\n\nOne of the less commonly recognized side effects of opiate use is sleep disruption.\n\nExperimentally-induced sleep disruption lowers the threshold for detection of painful stimuli. Thus, although opiates are obviously helpful for pain, they do so at certain "costs": they increase next day fatigue, constipation, and have other side effects; they disrupt sleep which further increases next day fatigue; and finally, by virtue of their sleep disruptive properties, they lower the threshold for pain stimuli.\n\nCancer patients requiring chemotherapy commonly require PCA because of oral mucositis. The objective of this study is to assess whether opiate usage may be reduced and complaints of fatigue and pain be lessened if patients had better sleep.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female patients hospitalized for chemotherapy or blood/bone marrow transplant.\n2. Age 20 - 75\n3. Not currently regularly taking any prescribed sleeping pill more often than 4x/week.\n4. Can tolerate oral medication.\n\nExclusion Criteria:\n\n1. Patients with a current history of substance abuse\n2. Patients with a history of allergic response to Lunesta.\n3. Patient who require additional oral or parenteral opioids after starting PCA opioid treatment.'}, 'identificationModule': {'nctId': 'NCT00365261', 'briefTitle': 'Effect of Eszopiclone on Sleep Disturbance and Pain in Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Diego'}, 'officialTitle': 'Effect of Eszopiclone (Lunesta) on Sleep Disturbance and Pain in Cancer', 'orgStudyIdInfo': {'id': 'UCSD 060340'}, 'secondaryIdInfos': [{'id': 'ESRC 054', 'type': 'OTHER', 'domain': 'Sepracor'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'eszopiclone', 'description': 'active drug', 'interventionNames': ['Drug: Eszopiclone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Eszopiclone', 'type': 'DRUG', 'otherNames': ['Lunesta'], 'description': 'eszopiclone 2 to 3 mg po at bedtime', 'armGroupLabels': ['eszopiclone']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'placebo 2 to 3 mg po at bedtime', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'UCSD Thornton Hospital', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}], 'overallOfficials': [{'name': 'Joel E Dimsdale, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UCSD'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Diego', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Joel E. Dimsdale, M.D.', 'investigatorAffiliation': 'University of California, San Diego'}}}}