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A Double-blind, Parallel Group, Placebo-Controlled Outpatient Trial of PD 00200390 in Adults With Nonrestorative Sleep

NCT ID: NCT00655369

Last Updated: 2012-07-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

306 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2008-12-31

Brief Summary

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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

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Conditions

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Nonrestorative Sleep

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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15 mg

Group Type EXPERIMENTAL

PD 0200390

Intervention Type DRUG

oral 15 mg daily dose, 3 capsules per dose during a six week treatment period.

25 mg

Group Type EXPERIMENTAL

PD 0200390

Intervention Type DRUG

oral 25 mg daily dose, 3 capsules per dose during a six week treatment period.

35 mg

Group Type EXPERIMENTAL

PD 0200390

Intervention Type DRUG

oral 35 mg daily dose, 3 capsules per dose during a six week treatment period.

5 mg

Group Type EXPERIMENTAL

PD 0200390

Intervention Type DRUG

oral 5 mg daily dose, 3 capsules per dose during a six week treatment period.

50 mg

Group Type EXPERIMENTAL

PD 0200390

Intervention Type DRUG

oral 50 mg daily dose, 3 capsules per dose during a six week treatment period.

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

oral placebo daily dose, 3 capsules per dose during a six week treatment period.

Interventions

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PD 0200390

oral 15 mg daily dose, 3 capsules per dose during a six week treatment period.

Intervention Type DRUG

PD 0200390

oral 25 mg daily dose, 3 capsules per dose during a six week treatment period.

Intervention Type DRUG

PD 0200390

oral 35 mg daily dose, 3 capsules per dose during a six week treatment period.

Intervention Type DRUG

PD 0200390

oral 5 mg daily dose, 3 capsules per dose during a six week treatment period.

Intervention Type DRUG

PD 0200390

oral 50 mg daily dose, 3 capsules per dose during a six week treatment period.

Intervention Type DRUG

Placebo

oral placebo daily dose, 3 capsules per dose during a six week treatment period.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Glendale, Arizona, United States

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Phoenix, Arizona, United States

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Tucson, Arizona, United States

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Little Rock, Arkansas, United States

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Los Angeles, California, United States

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Pasadena, California, United States

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San Diego, California, United States

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San Francisco, California, United States

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Tustin, California, United States

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Wheat Ridge, Colorado, United States

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North Haven, Connecticut, United States

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Wallingford, Connecticut, United States

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DeLand, Florida, United States

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Miami, Florida, United States

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Naples, Florida, United States

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Orange City, Florida, United States

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Orlando, Florida, United States

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Pembroke Pines, Florida, United States

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South Miami, Florida, United States

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Atlanta, Georgia, United States

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Atlanta, Georgia, United States

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Gainesville, Georgia, United States

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Chicago, Illinois, United States

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Indianapolis, Indiana, United States

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Overland Park, Kansas, United States

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Crestview Hills, Kentucky, United States

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Lexington, Kentucky, United States

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Lexington, Kentucky, United States

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Baton Rouge, Louisiana, United States

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Chevy Chase, Maryland, United States

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Brighton, Massachusetts, United States

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North Dartmouth, Massachusetts, United States

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Chesterfield, Missouri, United States

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St Louis, Missouri, United States

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Las Vegas, Nevada, United States

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Las Vegas, Nevada, United States

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West Seneca, New York, United States

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Cary, North Carolina, United States

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Raleigh, North Carolina, United States

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Raleigh, North Carolina, United States

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Salisbury, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Cincinnati, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Clarks Summit, Pennsylvania, United States

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Uniontown, Pennsylvania, United States

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Warwick, Rhode Island, United States

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West Warwick, Rhode Island, United States

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Columbia, South Carolina, United States

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Austin, Texas, United States

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Dallas, Texas, United States

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Irving, Texas, United States

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Kelowna, British Columbia, Canada

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Kelowna, British Columbia, Canada

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Etobicoke, Ontario, Canada

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Kitchener, Ontario, Canada

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Parry Sound, Ontario, Canada

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Toronto, Ontario, Canada

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Toronto, Ontario, Canada

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Countries

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United States Canada

References

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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.

Reference Type DERIVED
PMID: 25024650 (View on PubMed)

Related Links

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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

To obtain contact information for a study center near you, click here.

Other Identifiers

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A4251033

Identifier Type: -

Identifier Source: org_study_id