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

PD 0200390 Dose-Ranging Trial: A Randomized, Double-Blind, Parallel Group, Placebo-Controlled, Multicenter Outpatient Trial of PD 0200390 in Adults With Nonrestorative Sleep

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.

Study Overview

• Status: Completed
• Conditions: Nonrestorative Sleep
• Intervention / Treatment: Drug: PD 0200390; Drug: PD 0200390; Drug: PD 0200390; Drug: PD 0200390; Drug: PD 0200390; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 306
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Kelowna, British Columbia, Canada, V1Y 3G8
      • Pfizer Investigational Site
    • Kelowna, British Columbia, Canada, V1Y 4R9
      • Pfizer Investigational Site
  • Ontario
    • Etobicoke, Ontario, Canada, M9W 6V1
      • Pfizer Investigational Site
    • Kitchener, Ontario, Canada, N2G 1G1
      • Pfizer Investigational Site
    • Parry Sound, Ontario, Canada, P2A 3A4
      • Pfizer Investigational Site
    • Toronto, Ontario, Canada, M6J 3S3
      • Pfizer Investigational Site
    • Toronto, Ontario, Canada, M4P 1P2
      • Pfizer Investigational Site
• United States
  • Arizona
    • Glendale, Arizona, United States, 85306
      • Pfizer Investigational Site
    • Phoenix, Arizona, United States, 85306
      • Pfizer Investigational Site
    • Tucson, Arizona, United States, 85712
      • Pfizer Investigational Site
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Pfizer Investigational Site
  • California
    • Los Angeles, California, United States, 90048
      • Pfizer Investigational Site
    • Pasadena, California, United States, 91106
      • Pfizer Investigational Site
    • San Diego, California, United States, 92103
      • Pfizer Investigational Site
    • San Francisco, California, United States, 94105
      • Pfizer Investigational Site
    • Tustin, California, United States, 92780
      • Pfizer Investigational Site
  • Colorado
    • Wheat Ridge, Colorado, United States, 80033
      • Pfizer Investigational Site
  • Connecticut
    • North Haven, Connecticut, United States, 06473
      • Pfizer Investigational Site
    • Wallingford, Connecticut, United States, 06492
      • Pfizer Investigational Site
  • Florida
    • DeLand, Florida, United States, 32720
      • Pfizer Investigational Site
    • Miami, Florida, United States, 33143
      • Pfizer Investigational Site
    • Naples, Florida, United States, 34110
      • Pfizer Investigational Site
    • Orange City, Florida, United States, 32763
      • Pfizer Investigational Site
    • Orlando, Florida, United States, 32806
      • Pfizer Investigational Site
    • Pembroke Pines, Florida, United States, 33026
      • Pfizer Investigational Site
    • South Miami, Florida, United States, 33143
      • Pfizer Investigational Site
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Pfizer Investigational Site
    • Atlanta, Georgia, United States, 30328
      • Pfizer Investigational Site
    • Gainesville, Georgia, United States, 30501
      • Pfizer Investigational Site
  • Illinois
    • Chicago, Illinois, United States, 60634
      • Pfizer Investigational Site
  • Indiana
    • Indianapolis, Indiana, United States, 46260
      • Pfizer Investigational Site
  • Kansas
    • Overland Park, Kansas, United States, 66212
      • Pfizer Investigational Site
  • Kentucky
    • Crestview Hills, Kentucky, United States, 41017
      • Pfizer Investigational Site
    • Lexington, Kentucky, United States, 40504
      • Pfizer Investigational Site
    • Lexington, Kentucky, United States, 40513
      • Pfizer Investigational Site
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70809
      • Pfizer Investigational Site
  • Maryland
    • Chevy Chase, Maryland, United States, 20815
      • Pfizer Investigational Site
  • Massachusetts
    • Brighton, Massachusetts, United States, 02135
      • Pfizer Investigational Site
    • N. Dartmouth, Massachusetts, United States, 02747
      • Pfizer Investigational Site
  • Missouri
    • Chesterfield, Missouri, United States, 63017
      • Pfizer Investigational Site
    • St. Louis, Missouri, United States, 63108
      • Pfizer Investigational Site
  • Nevada
    • Las Vegas, Nevada, United States, 89146
      • Pfizer Investigational Site
    • Las Vegas, Nevada, United States, 89104
      • Pfizer Investigational Site
  • New York
    • West Seneca, New York, United States, 14224
      • Pfizer Investigational Site
  • North Carolina
    • Cary, North Carolina, United States, 27511
      • Pfizer Investigational Site
    • Raleigh, North Carolina, United States, 27612
      • Pfizer Investigational Site
    • Raleigh, North Carolina, United States, 27607-6520
      • Pfizer Investigational Site
    • Salisbury, North Carolina, United States, 28144
      • Pfizer Investigational Site
    • Winston Salem, North Carolina, United States, 27103
      • Pfizer Investigational Site
    • Winston-Salem, North Carolina, United States, 27103
      • Pfizer Investigational Site
  • Ohio
    • Cincinnati, Ohio, United States, 45227
      • Pfizer Investigational Site
  • Oklahoma
    • Oklahoma, Oklahoma, United States, 73112
      • Pfizer Investigational Site
  • Pennsylvania
    • Clarks Summit, Pennsylvania, United States, 18411
      • Pfizer Investigational Site
    • Uniontown, Pennsylvania, United States, 15401
      • Pfizer Investigational Site
  • Rhode Island
    • Warwick, Rhode Island, United States, 02886
      • Pfizer Investigational Site
    • West Warwick, Rhode Island, United States, 02893
      • Pfizer Investigational Site
  • South Carolina
    • Columbia, South Carolina, United States, 29201
      • Pfizer Investigational Site
  • Texas
    • Austin, Texas, United States, 78756
      • Pfizer Investigational Site
    • Dallas, Texas, United States, 75230
      • Pfizer Investigational Site
    • Irving, Texas, United States, 75039
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; oral placebo daily dose, 3 capsules per dose during a six week treatment period.
Experimental: 50 mg	Drug: PD 0200390; oral 15 mg daily dose, 3 capsules per dose during a six week treatment period.; Drug: PD 0200390; oral 25 mg daily dose, 3 capsules per dose during a six week treatment period.; Drug: PD 0200390; oral 35 mg daily dose, 3 capsules per dose during a six week treatment period.; Drug: PD 0200390; oral 5 mg daily dose, 3 capsules per dose during a six week treatment period.; Drug: PD 0200390; oral 50 mg daily dose, 3 capsules per dose during a six week treatment period.
Experimental: 15 mg	Drug: PD 0200390; oral 15 mg daily dose, 3 capsules per dose during a six week treatment period.; Drug: PD 0200390; oral 25 mg daily dose, 3 capsules per dose during a six week treatment period.; Drug: PD 0200390; oral 35 mg daily dose, 3 capsules per dose during a six week treatment period.; Drug: PD 0200390; oral 5 mg daily dose, 3 capsules per dose during a six week treatment period.; Drug: PD 0200390; oral 50 mg daily dose, 3 capsules per dose during a six week treatment period.
Experimental: 25 mg	Drug: PD 0200390; oral 15 mg daily dose, 3 capsules per dose during a six week treatment period.; Drug: PD 0200390; oral 25 mg daily dose, 3 capsules per dose during a six week treatment period.; Drug: PD 0200390; oral 35 mg daily dose, 3 capsules per dose during a six week treatment period.; Drug: PD 0200390; oral 5 mg daily dose, 3 capsules per dose during a six week treatment period.; Drug: PD 0200390; oral 50 mg daily dose, 3 capsules per dose during a six week treatment period.
Experimental: 35 mg	Drug: PD 0200390; oral 15 mg daily dose, 3 capsules per dose during a six week treatment period.; Drug: PD 0200390; oral 25 mg daily dose, 3 capsules per dose during a six week treatment period.; Drug: PD 0200390; oral 35 mg daily dose, 3 capsules per dose during a six week treatment period.; Drug: PD 0200390; oral 5 mg daily dose, 3 capsules per dose during a six week treatment period.; Drug: PD 0200390; oral 50 mg daily dose, 3 capsules per dose during a six week treatment period.
Experimental: 5 mg	Drug: PD 0200390; oral 15 mg daily dose, 3 capsules per dose during a six week treatment period.; Drug: PD 0200390; oral 25 mg daily dose, 3 capsules per dose during a six week treatment period.; Drug: PD 0200390; oral 35 mg daily dose, 3 capsules per dose during a six week treatment period.; Drug: PD 0200390; oral 5 mg daily dose, 3 capsules per dose during a six week treatment period.; Drug: PD 0200390; oral 50 mg daily dose, 3 capsules per dose during a six week treatment period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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)	Weekly

Secondary Outcome Measures

Outcome Measure	Time Frame
Measure sleep and early morning behavior during treatment using the Leeds Sleep Evaluation Questionnaire	Weeky
Total score of the Daily Restorative Sleep Questionnaire	Daily
Total score of the Multidimensional Assessment of Fatigue (MAF)	Weekly
Total score of the Sheehan Disability Scale to measure functional impairment	Weekly
Measure of health status using the Medical Outcomes Study Short Form-36 (SF-36v2-Acute)	Weekly
Total mood disturbance score using the Profile of Mood State-Short Form Questionnaire (POMS-SF)	Weekly
Total score of the Endicott Work Productivity Scale (EWPS) measuring work productivity.	Weekly
Disease severity and change using the Clinical Global Impression of Severity (CGI-S) as rated by the Clinician.	Weekly
Disease change (patient rated) measure using the Patient Global Impression of Change (PGIC).	Weekly

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

General 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.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (Actual): December 1, 2008
• Study Completion (Actual): December 1, 2008

Study Registration Dates

• First Submitted: April 3, 2008
• First Submitted That Met QC Criteria: April 3, 2008
• First Posted (Estimate): April 9, 2008

Study Record Updates

• Last Update Posted (Estimate): July 25, 2012
• Last Update Submitted That Met QC Criteria: July 17, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Other Study ID Numbers: A4251033