Ignite Creation Date:
2025-12-24 @ 3:14 PM
Ignite Modification Date:
2025-12-30 @ 10:38 PM
Study NCT ID:
NCT00748592
Status:
WITHDRAWN
Last Update Posted:
2009-02-12
First Post:
2008-09-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Dose-Ranging, Multicenter Polysomnography Trial of PD 0200390 in Elderly Subjects With Primary Insomnia
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': 'C547571', 'term': '(1-aminomethyl-3,4-dimethylcyclopentyl)acetic acid'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-02', 'completionDateStruct': {'date': '2009-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-02-11', 'studyFirstSubmitDate': '2008-09-05', 'studyFirstSubmitQcDate': '2008-09-05', 'lastUpdatePostDateStruct': {'date': '2009-02-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-09-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Wake After Sleep Onset (WASO) as determined by PSG assessment', 'timeFrame': 'Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23'}], 'secondaryOutcomes': [{'measure': 'Sleep and early morning behavior as determined by Leeds Sleep Evaluation Questionnaire (LSEQ)', 'timeFrame': 'Days -6, -5, 2, 3, 9, 10, 16, 17, 23, and 24'}, {'measure': 'Latency to persistent sleep (LPS) as determined by PSG assessment', 'timeFrame': 'Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23'}, {'measure': 'Latency to REM Sleep as determined by PSG assessment', 'timeFrame': 'Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23'}, {'measure': 'Sleep efficiency (SE) as determined by PSG assessment', 'timeFrame': 'Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23'}, {'measure': 'Number of awakenings after sleep onset (NAASO) as determined by PSG assessment', 'timeFrame': 'Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23'}, {'measure': 'Total wake time (TWT) as determined by PSG assessment', 'timeFrame': 'Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23'}, {'measure': 'Next day sleepiness as determined by Visual Analog Scale (VAS) for Sleepiness', 'timeFrame': 'Days -6, -5, 2, 3, 9, 10, 16, 17, 23, and 24'}, {'measure': 'Number of arousals as determined by PSG assessment', 'timeFrame': 'Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23'}, {'measure': 'Total sleep time (TST) as determined by PSG assessment', 'timeFrame': 'Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23'}, {'measure': 'Next day performance sa determined by Digit Symbol Substitution Test (DSST)', 'timeFrame': 'Days -6, -5, 2, 3, 9, 10, 16, 17, 23, and 24'}, {'measure': 'Subjective Sleep Onset and Maintenance as determined by Subjective Sleep Questionnaire (SSQ)', 'timeFrame': 'Days -6, -5, 2, 3, 9, 10, 16, 17, 23, and 24'}, {'measure': 'Wake time during sleep (WTDS) as determined by PSG assessment', 'timeFrame': 'Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23'}, {'measure': 'Wake time after sleep (WTAS) as determined by PSG assessment', 'timeFrame': 'Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23'}, {'measure': 'Percentages of Stage 1 Sleep, Stage 2 Sleep, Stage 3+4 Sleep, Stage REM Sleep as determined by PSG assessment', 'timeFrame': 'Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23'}, {'measure': 'Restorative sleep as determined by Restorative Sleep Questionnaire Daily (RSQ D)', 'timeFrame': 'Days -6, -5, 2, 3, 9, 10, 16, 17, 23, and 24'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Insomnia, Primary Insomnia, Chronic Insomnia, DIMS (Disorders of Initiating and Maintaining Sleep), Disorders of Initiating and Maintaining Sleep'], 'conditions': ['Insomnia']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A4251026&StudyName=A%20Dose-Ranging%2C%20Multicenter%20Polysomnography%20Trial%20of%20PD%200200390%20in%20Elderly%20Subjects%20With%20Primary%20Insomnia%0A', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'This is a randomized, double-blind, placebo-controlled, multicenter trial with a 4-way crossover design. Elderly subjects with primary insomnia who meet screening requirements will initially be randomized into the study and receive the first of 4 treatments (PD 0200390 5 mg, 15 mg and 30 mg or placebo) daily 30 minutes before bed time for 2 consecutive days in a polysomnography (PSG) lab.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 3 month history of primary insomnia\n* Difficulty initiating and maintaining sleep for at least 3 nights/week for the past month (difficulty falling asleep, difficulty staying asleep, early awakening)\n\nExclusion Criteria:\n\n* Any history of psychiatric diagnosis\n* History or presence of any breathing related sleep disorder\n* History or presence of any medical or neurological condition that could interfere with sleep\n* Use of alcohol as a sleep aid or more than 2 standard drinks consumed per day or more than 14 consumed per week'}, 'identificationModule': {'nctId': 'NCT00748592', 'briefTitle': 'A Dose-Ranging, Multicenter Polysomnography Trial of PD 0200390 in Elderly Subjects With Primary Insomnia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'PD 0200390 Dose-Ranging Trial: A Randomized, Double-Blind, Placebo-Controlled, 4-Way Crossover, Multicenter Polysomnography Trial Of PD 0200390 In Elderly Subjects With Primary Insomnia', 'orgStudyIdInfo': {'id': 'A4251026'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'PD 0200390, 5 mg', 'interventionNames': ['Drug: PD 0200390']}, {'type': 'EXPERIMENTAL', 'label': 'PD 0200390, 15 mg', 'interventionNames': ['Drug: PD 0200390']}, {'type': 'EXPERIMENTAL', 'label': 'PD 0200390, 30 mg', 'interventionNames': ['Drug: PD 0200390']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'Subjects in this arm will be administered 3 capsules of placebo 30 minutes before bedtime for two consecutive nights in the sleep lab.', 'armGroupLabels': ['Placebo']}, {'name': 'PD 0200390', 'type': 'DRUG', 'description': 'Subjects in this arm will be administered 3 capsules totaling 5 milligrams 30 minutes before bedtime for two consecutive nights in the sleep lab.', 'armGroupLabels': ['PD 0200390, 5 mg']}, {'name': 'PD 0200390', 'type': 'DRUG', 'description': 'Subjects in this arm will be administered 3 capsules totaling 15 milligrams 30 minutes before bedtime for two consecutive nights in the sleep lab.', 'armGroupLabels': ['PD 0200390, 15 mg']}, {'name': 'PD 0200390', 'type': 'DRUG', 'description': 'Subjects in this arm will be administered 3 capsules totaling 30 milligrams 30 minutes before bedtime for two consecutive nights in the sleep lab.', 'armGroupLabels': ['PD 0200390, 30 mg']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Director, Clinical Trial Disclosure Group', 'oldOrganization': 'Pfizer, Inc.'}}}}