A Double-blind, Parallel Group, Placebo-Controlled Outpatient Trial of PD 00200390 in Adults With Nonrestorative Sleep
NCT00655369
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- 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
- Self-report wake after sleep onset <45 mins for past 3 mos; self-report latency to sleep onset <20 mins for past 3 mos
- PSG (Polysomnography) sleep criteria of wake after sleep onset < 45 mins; Latency to persistent sleep <20 mins.
- MAP (Multivariable Apnea Risk index) index > or = 0.5 at screening
- BMI = or > 32 kg/m2
- History or presence of breathing related disorders
- 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.
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Descriptive Information | ||||
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Brief Title ICMJE | A Double-blind, Parallel Group, Placebo-Controlled Outpatient Trial of PD 00200390 in Adults With Nonrestorative Sleep | |||
Official Title ICMJE | PD 0200390 Dose-Ranging Trial: A Randomized, Double-Blind, Parallel Group, Placebo-Controlled, Multicenter Outpatient Trial of PD 0200390 in Adults With Nonrestorative Sleep | |||
Brief Summary | 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. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment | |||
Condition ICMJE | Nonrestorative Sleep | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | 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. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 306 | |||
Original Estimated Enrollment ICMJE | 300 | |||
Actual Study Completion Date ICMJE | December 2008 | |||
Actual Primary Completion Date | December 2008 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 64 Years (Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Canada, United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00655369 | |||
Other Study ID Numbers ICMJE | A4251033 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Pfizer | |||
Verification Date | July 2012 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |