Ignite Creation Date:
2025-12-24 @ 3:17 PM
Ignite Modification Date:
2025-12-27 @ 8:05 PM
Study NCT ID:
NCT01024192
Status:
COMPLETED
Last Update Posted:
2010-10-05
First Post:
2009-11-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety Assessment of ZOlpidem (Stilnox CR) in Patients With Chronic insomNIA
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012893', 'term': 'Sleep Wake Disorders'}], 'ancestors': [{'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 135}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-10', 'completionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-10-04', 'studyFirstSubmitDate': '2009-11-30', 'studyFirstSubmitQcDate': '2009-11-30', 'lastUpdatePostDateStruct': {'date': '2010-10-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement of the Clinical Global Impression (CGI) score', 'timeFrame': 'At day 84 (visit 5)'}], 'secondaryOutcomes': [{'measure': 'Illness severity and average change during the study', 'timeFrame': 'At day 1 (baseline), day 14 (visit 2), day 28 (visit 3), day 56 (visit 4) and day 84 (visit 5)'}, {'measure': 'Pittsburgh Sleep Quality Index (PSQI) score', 'timeFrame': 'At day 1 (baseline), day 28 (visit 3), day 56 (visit 4) and day 84 (visit 5)'}, {'measure': 'Patient satisfaction questionnaire', 'timeFrame': 'At day 84 (visit 5)'}, {'measure': 'Safety evaluation via Adverse events reported', 'timeFrame': 'At day 14 (visit 2), day 28 (visit 3), day 56 (visit 4) and day 84 (visit 5)'}]}, 'conditionsModule': {'conditions': ['Sleep Disorders']}, 'descriptionModule': {'briefSummary': 'Primary Objective:\n\nTo evaluate the efficacy and safety of the use of Stilnox CR in Mexican patients with chronic insomnia at the prescription conditions of daily practice\n\nSecondary Objective:\n\nTo evaluate the satisfaction of the patient with chronic insomnia with Stilnox CR over an as needed basis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n\\- Primary insomnia diagnosis (difficulty for initiating sleep, or maintaining sleep to wake up to early in the morning, or to present a restless sleep) which causes clinically significant disturbances in the areas of social, work functioning or other important areas\n\nExclusion criteria:\n\n* Serious, severe and/or acute respiratory impairment\n* Severe liver impairment\n* Hypersensitivity to the formulation components or to some of its active metabolites\n* Pregnant or breast-feeding women Patients with important associated disorders in SNC and specially psychotic disorders\n* Patients with the probability of using alcoholic beverages concomitantly (as a precaution measure)\n* Chronic use of benzodiazepines\n\nMoreover, in order to follow the international regulations in terms of the use and handling of hypnotic compounds, and to guarantee the appropriate study performance, no patients with one or more of the following characteristics should be included:\n\n* Patients who cannot comply to follow-up\n* Patients who have any drug abuse problem\n* Individuals who work changing night shifts or with pathological snoring\n* Presence (or suspicion) of sleep apnea, periodical legs movements or restless legs syndrome\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT01024192', 'briefTitle': 'Efficacy and Safety Assessment of ZOlpidem (Stilnox CR) in Patients With Chronic insomNIA', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Efficacy and Safety Assessment of ZOlpidem (Stilnox CR) Administered on as Needed Basis in Patients With Chronic insomNIA', 'orgStudyIdInfo': {'id': 'ZOLPI_L_04134'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Zolpidem 12.5mg tablet at bed time during 12 weeks', 'interventionNames': ['Drug: ZOLPIDEM SL800750']}], 'interventions': [{'name': 'ZOLPIDEM SL800750', 'type': 'DRUG', 'description': 'Pharmaceutical form: Zopidem 12.5 mg tablets\n\nRoute of administration: Oral\n\nDose regimen:One tablet at bed time and as needed (the patients choose which night they take the tablet without limit of number of nights)', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Col. Coyoacan', 'country': 'Mexico', 'facility': 'Sanofi-Aventis Administrative Office'}], 'overallOfficials': [{'name': 'Medical Affairs', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Medical Affairs Study Director', 'oldOrganization': 'sanofi-aventis'}}}}