Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2026-04-13 @ 9:21 PM
Study NCT ID:
NCT00992160
Status:
COMPLETED
Last Update Posted:
2016-10-28
First Post:
2009-07-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vestipitant 28-day Tolerance Study
Sponsor:
Organization:
Raw JSON
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'interventionBrowseModule': {'meshes': [{'id': 'C534550', 'term': 'vestipitant'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 161}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-26', 'studyFirstSubmitDate': '2009-07-16', 'studyFirstSubmitQcDate': '2009-10-08', 'lastUpdatePostDateStruct': {'date': '2016-10-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-10-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Nocturnal polysomngraphy', 'timeFrame': '6 weeks after start of treatment'}], 'secondaryOutcomes': [{'measure': 'Subjective sleep assessments as performed by Post-Sleep Questionnaires and subject -rated Insomnia Severity Index', 'timeFrame': '4 weeks after start of treatment'}, {'measure': 'Motor and cognitive functioning assessed by neurological tests (Romberg and Hee-to-toe) and Cognitive tests (Digit Symbol Substitution test and verbal Learning Memory test)', 'timeFrame': '4 weeks after start of treatment'}]}, 'conditionsModule': {'keywords': ['Polysomnography (PSG)', 'Adults', 'Primary Insomnia'], 'conditions': ['Sleep Disorders']}, 'referencesModule': {'availIpds': [{'id': '111364', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Clinical Study Report', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '111364', 'url': 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Disorders -Text Revision (DSM-IV-TR) criteria 307.42\n* PSG variables collected during 2consecutive PSG screening nights falling as follows: TST between 240-420 mins inclusive (both nights) - LPS (Latency to Persistent Sleep): mean not less than 20mins, each night not less than 15 mins - WASO (Wake After Sleep Onset): mean not less than 60mins, each night not less than 45mins\n* Women: non child bearing potential or if child bearing potential agree on Contraceptive Methods listed in Protocol\n\nExclusion Criteria:\n\n* clinically significant Psychiatric and neurological disorders (sleep disorders other than Primary Insomnia, history of alcohol orother substance abuse or dependnce);\n* nightshift or rotating shift-work;\n* Lifestyle habits in agreement with Protocol requirement: caffeine - alcohol intake and smoke\n* healthy according to GSK criteria - laboratory and ECG limits set in the Protocol'}, 'identificationModule': {'nctId': 'NCT00992160', 'briefTitle': 'Vestipitant 28-day 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