Ignite Creation Date:
2025-12-24 @ 10:02 PM
Ignite Modification Date:
2025-12-28 @ 7:31 AM
Study NCT ID:
NCT01181232
Status:
COMPLETED
Last Update Posted:
2014-09-10
First Post:
2010-08-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Compare Efficacy and Safety of Zolpidem Modified Release Formulation Versus Zolpidem in Insomnia Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077334', 'term': 'Zolpidem'}], 'ancestors': [{'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 132}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-09-09', 'studyFirstSubmitDate': '2010-08-04', 'studyFirstSubmitQcDate': '2010-08-12', 'lastUpdatePostDateStruct': {'date': '2014-09-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-08-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rest/activity cycles measured by Actigraphy', 'timeFrame': 'For 2 weeks (Day 0, Day 7, Day 14)'}, {'measure': 'Total score of Pittsburgh Sleep Quality Index (PSQI)', 'timeFrame': 'For 2 weeks (Day 0, Day 7, Day 14)'}], 'secondaryOutcomes': [{'measure': "Physician's clinical global impression (CGI)", 'timeFrame': 'For 2 weeks (Day 0, Day 7, Day 14)'}, {'measure': "Patient's global impression (PGI)", 'timeFrame': 'For 2 weeks (Day 0, Day 7, Day 14)'}, {'measure': 'Sleep latency as derived from sleep diary', 'timeFrame': 'For 2 weeks (Day 0, Day 7, Day 14)'}, {'measure': 'Number of awakenings as derived from sleep diary', 'timeFrame': 'For 2 weeks (Day 0, Day 7, Day 14)'}, {'measure': 'Total sleep time as derived from sleep diary', 'timeFrame': 'For 2 weeks (Day 0, Day 7, Day 14)'}, {'measure': 'Wake time after sleep onset as derived from sleep diary', 'timeFrame': 'For 2 weeks (Day 0, Day 7, Day 14)'}, {'measure': 'Day time function as assessed by Epworth Sleepiness Scale (ESS)', 'timeFrame': 'For 2 weeks (Day 0, Day 7, Day 14)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['insomnia', 'zolpidem'], 'conditions': ['Sleep Initiation and Maintenance Disorders', 'Primary Insomnia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the efficacy and safety of zolpidem MR (modified release) compared to zolpidem IR (immediate release) in patients with primary insomnia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of primary insomnia based on DSM-IV criteria (307.42)\n* Written informed consent has been obtained\n\nExclusion Criteria:\n\n* Patients with sleep apnea syndrome, narcolepsy, presence or suspicion of periodic leg movement or restless leg syndrome\n* Patients with hepatic failure, myasthenia gravis, or hypersensitivity to zolpidem\n* Patients who are known to be current drug or alcohol abuser or likely to concomitantly consume alcoholic beverages (more than 3 times/week)\n* Patients who have received antihistamines or antipsychotics will not allow to discontinue the previous medication throughout the study\n* Patients who are pregnant, lactating or intend to become pregnant during the study period\n* Patients who have received antidepressants or anxiolytics will not allow to change the dose or discontinue the previous medication throughout the study\n* Any clinically significant condition, which in the opinion of the investigator makes the patients unsuitable for the trial\n* Participation in any clinical trial within 1 month prior to randomization'}, 'identificationModule': {'nctId': 'NCT01181232', 'briefTitle': 'A Study to Compare Efficacy and Safety of Zolpidem Modified Release Formulation Versus Zolpidem in Insomnia Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Astellas Pharma Inc'}, 'officialTitle': 'A Randomized, Active Control, Parallel Study to Evaluate the Efficacy and Safety of Zolpidem MR (Stilnox CR) Versus Zolpidem (Stilnox) in Patients With Primary Insomnia', 'orgStudyIdInfo': {'id': 'STCR-0901-TW'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MR low-dose group', 'interventionNames': ['Drug: Zolpidem MR']}, {'type': 'EXPERIMENTAL', 'label': 'MR high-dose group', 'interventionNames': ['Drug: Zolpidem MR']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'IR group', 'interventionNames': ['Drug: Zolpidem IR']}], 'interventions': [{'name': 'Zolpidem MR', 'type': 'DRUG', 'otherNames': ['Stilnox CR', 'Ambient CR'], 'description': 'oral', 'armGroupLabels': ['MR high-dose group', 'MR low-dose group']}, {'name': 'Zolpidem IR', 'type': 'DRUG', 'otherNames': ['Stilnox'], 'description': 'oral', 'armGroupLabels': ['IR group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '704', 'city': 'Tainan', 'country': 'Taiwan', 'geoPoint': {'lat': 22.99083, 'lon': 120.21333}}, {'zip': '100', 'city': 'Taipei', 'country': 'Taiwan', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Use Central Contact', 'role': 'STUDY_CHAIR', 'affiliation': 'Astellas Pharma Inc'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Astellas Pharma Inc', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Astellas Pharma Taiwan, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}