Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2026-02-25 @ 6:59 PM
Study NCT ID:
NCT00655369
Status:
COMPLETED
Last Update Posted:
2012-07-25
First Post:
2008-04-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Double-blind, Parallel Group, Placebo-Controlled Outpatient Trial of PD 00200390 in Adults With Nonrestorative Sleep
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C547571', 'term': '(1-aminomethyl-3,4-dimethylcyclopentyl)acetic acid'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 306}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'dispFirstSubmitDate': '2009-12-10', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-07-17', 'studyFirstSubmitDate': '2008-04-03', 'dispFirstSubmitQcDate': '2009-12-10', 'studyFirstSubmitQcDate': '2008-04-03', 'dispFirstPostDateStruct': {'date': '2009-12-14', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2012-07-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-04-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total score of how an individual rates the restorative value of his/her sleep in the morning using the weekly version of the Restorative Sleep Questionnaire (RSQ-Weekly)', 'timeFrame': 'Weekly'}], 'secondaryOutcomes': [{'measure': 'Measure sleep and early morning behavior during treatment using the Leeds Sleep Evaluation Questionnaire', 'timeFrame': 'Weeky'}, {'measure': 'Total score of the Daily Restorative Sleep Questionnaire', 'timeFrame': 'Daily'}, {'measure': 'Total score of the Multidimensional Assessment of Fatigue (MAF)', 'timeFrame': 'Weekly'}, {'measure': 'Total score of the Sheehan Disability Scale to measure functional impairment', 'timeFrame': 'Weekly'}, {'measure': 'Measure of health status using the Medical Outcomes Study Short Form-36 (SF-36v2-Acute)', 'timeFrame': 'Weekly'}, {'measure': 'Total mood disturbance score using the Profile of Mood State-Short Form Questionnaire (POMS-SF)', 'timeFrame': 'Weekly'}, {'measure': 'Total score of the Endicott Work Productivity Scale (EWPS) measuring work productivity.', 'timeFrame': 'Weekly'}, {'measure': 'Disease severity and change using the Clinical Global Impression of Severity (CGI-S) as rated by the Clinician.', 'timeFrame': 'Weekly'}, {'measure': 'Disease change (patient rated) measure using the Patient Global Impression of Change (PGIC).', 'timeFrame': 'Weekly'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Nonrestorative Sleep']}, 'referencesModule': {'references': [{'pmid': '25024650', 'type': 'DERIVED', 'citation': 'Drake CL, Hays RD, Morlock R, Wang F, Shikiar R, Frank L, Downey R, Roth T. Development and evaluation of a measure to assess restorative sleep. J Clin Sleep Med. 2014 Jul 15;10(7):733-41, 741A-741E. doi: 10.5664/jcsm.3860.'}], 'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A4251033&StudyName=A%20Double-blind%2C%20Parallel%20group%2C%20Placebo-Controlled%20Outpatient%20Trial%20of%20PD%2000200390%20in%20Adults%20with%20Nonrestorative%20Sleep', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'In a Phase II trial in subjects with nonrestorative sleep, PD 0200390 demonstrated a positive treatment effect relative to placebo on the primary endpoint, the weekly version of the Restorative Sleep Questionnaire (RSQ-W). In this study, the dose-response relationship of varying doses of PD 0200390 using the Restorative Sleep Questionnaire (RSQ-W), will be explored in Nonrestorative Sleep subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Awake unrestored or unrefreshed, associated with significant distress or impairment in social, occupational, or other important areas of functioning during the daytime, for at least 3 nights for the past 3 months prior to screening\n* Self-report wake after sleep onset \\<45 mins for past 3 mos; self-report latency to sleep onset \\<20 mins for past 3 mos\n* PSG (Polysomnography) sleep criteria of wake after sleep onset \\< 45 mins; Latency to persistent sleep \\<20 mins.\n\nExclusion Criteria:\n\n* MAP (Multivariable Apnea Risk index) index \\> or = 0.5 at screening\n* BMI = or \\> 32 kg/m2\n* History or presence of breathing related disorders\n* PSG findings consistent with and periodic limb movement disorder, narcolepsy or other dyssomnia or parasomnia including apnea-hypopnea index \\> 10/hr; or period limb movement with arousal index \\> 10/hr.'}, 'identificationModule': {'nctId': 'NCT00655369', 'briefTitle': 'A Double-blind, Parallel Group, Placebo-Controlled Outpatient Trial of PD 00200390 in Adults With Nonrestorative Sleep', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'PD 0200390 Dose-Ranging Trial: A Randomized, Double-Blind, Parallel Group, Placebo-Controlled, Multicenter Outpatient Trial of PD 0200390 in Adults With Nonrestorative Sleep', 'orgStudyIdInfo': {'id': 'A4251033'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '15 mg', 'interventionNames': ['Drug: PD 0200390']}, {'type': 'EXPERIMENTAL', 'label': '25 mg', 'interventionNames': ['Drug: PD 0200390']}, {'type': 'EXPERIMENTAL', 'label': '35 mg', 'interventionNames': ['Drug: PD 0200390']}, {'type': 'EXPERIMENTAL', 'label': '5 mg', 'interventionNames': ['Drug: PD 0200390']}, {'type': 'EXPERIMENTAL', 'label': '50 mg', 'interventionNames': ['Drug: PD 0200390']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'PD 0200390', 'type': 'DRUG', 'description': 'oral 15 mg daily dose, 3 capsules per dose during a six week treatment period.', 'armGroupLabels': ['15 mg']}, {'name': 'PD 0200390', 'type': 'DRUG', 'description': 'oral 25 mg daily dose, 3 capsules per dose during a six week treatment period.', 'armGroupLabels': ['25 mg']}, {'name': 'PD 0200390', 'type': 'DRUG', 'description': 'oral 35 mg daily dose, 3 capsules per dose during a six week treatment period.', 'armGroupLabels': ['35 mg']}, {'name': 'PD 0200390', 'type': 'DRUG', 'description': 'oral 5 mg daily dose, 3 capsules per dose during a six week treatment period.', 'armGroupLabels': ['5 mg']}, {'name': 'PD 0200390', 'type': 'DRUG', 'description': 'oral 50 mg daily dose, 3 capsules per dose during a six week treatment period.', 'armGroupLabels': ['50 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'oral placebo daily dose, 3 capsules per dose during a six week treatment period.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85306', 'city': 'Glendale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 33.53865, 'lon': -112.18599}}, {'zip': '85306', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85712', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '91106', 'city': 'Pasadena', 'state': 'California', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 34.14778, 'lon': -118.14452}}, {'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '94105', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '92780', 'city': 'Tustin', 'state': 'California', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 33.74585, 'lon': -117.82617}}, {'zip': '80033', 'city': 'Wheat Ridge', 'state': 'Colorado', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 39.7661, 'lon': -105.07721}}, {'zip': '06473', 'city': 'North Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 41.39093, 'lon': -72.85954}}, {'zip': '06492', 'city': 'Wallingford', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 41.45704, 'lon': -72.82316}}, {'zip': '32720', 'city': 'DeLand', 'state': 'Florida', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 29.02832, 'lon': -81.30312}}, {'zip': '33143', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '34110', 'city': 'Naples', 'state': 'Florida', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 26.14234, 'lon': -81.79596}}, {'zip': '32763', 'city': 'Orange City', 'state': 'Florida', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 28.94888, 'lon': -81.29867}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '33026', 'city': 'Pembroke Pines', 'state': 'Florida', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 26.00315, 'lon': -80.22394}}, {'zip': '33143', 'city': 'South Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 25.7076, 'lon': -80.29338}}, {'zip': '30328', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30342', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30501', 'city': 'Gainesville', 'state': 'Georgia', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 34.29788, 'lon': -83.82407}}, {'zip': '60634', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '46260', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '66212', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}, {'zip': '41017', 'city': 'Crestview Hills', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 39.02728, 'lon': -84.58494}}, {'zip': '40504', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '40513', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '70809', 'city': 'Baton Rouge', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 30.44332, 'lon': -91.18747}}, {'zip': '20815', 'city': 'Chevy Chase', 'state': 'Maryland', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 39.00287, 'lon': -77.07115}}, {'zip': '02135', 'city': 'Brighton', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 42.3501, 'lon': -71.15644}}, {'zip': '02747', 'city': 'North Dartmouth', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 41.63899, 'lon': -70.97032}}, {'zip': '63017', 'city': 'Chesterfield', 'state': 'Missouri', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 38.66311, 'lon': -90.57707}}, {'zip': '63108', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '89104', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '89146', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '14224', 'city': 'West Seneca', 'state': 'New York', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 42.85006, 'lon': -78.79975}}, {'zip': '27511', 'city': 'Cary', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 35.79154, 'lon': -78.78112}}, {'zip': '27607-6520', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '27612', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '28144', 'city': 'Salisbury', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 35.67097, 'lon': -80.47423}}, {'zip': '27103', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '45227', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '73112', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '18411', 'city': 'Clarks Summit', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 41.48869, 'lon': -75.70852}}, {'zip': '15401', 'city': 'Uniontown', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 39.90008, 'lon': -79.71643}}, {'zip': '02886', 'city': 'Warwick', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 41.7001, 'lon': -71.41617}}, {'zip': '02893', 'city': 'West Warwick', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 41.69689, 'lon': -71.52194}}, {'zip': '29201', 'city': 'Columbia', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 34.00071, 'lon': -81.03481}}, {'zip': '78756', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '75230', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75039', 'city': 'Irving', 'state': 'Texas', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 32.81402, 'lon': -96.94889}}, {'zip': 'V1Y 3G8', 'city': 'Kelowna', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 49.88307, 'lon': -119.48568}}, {'zip': 'V1Y 4R9', 'city': 'Kelowna', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 49.88307, 'lon': -119.48568}}, {'zip': 'M9W 6V1', 'city': 'Etobicoke', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 43.64415, 'lon': -79.56985}}, {'zip': 'N2G 1G1', 'city': 'Kitchener', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 43.42537, 'lon': -80.5112}}, {'zip': 'P2A 3A4', 'city': 'Parry Sound', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 45.34732, 'lon': -80.03527}}, {'zip': 'M4P 1P2', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M6J 3S3', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}