A Randomized, Double Blind, Parallel Group, Placebo Controlled, Multicenter Outpatient Trial Of PD 0200390 In Adults With Primary Insomnia

July 17, 2012 updated by: Pfizer

PD 0200390 Dose Ranging Trial: A Randomized, Double Blind, Parallel Group, Placebo Controlled, Multicenter Outpatient Trial Of PD 0200390 In Adults With Primary Insomnia

To demonstrate efficacy and characterize the dose response relationship of PD 0200390 on subjective wake after sleep onset in subjects with primary insomnia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

682

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2X 2A8
        • Pfizer Investigational Site
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 2H4
        • Pfizer Investigational Site
    • Nova Scotia
      • Sydney, Nova Scotia, Canada, B1P 1C6
        • Pfizer Investigational Site
    • Ontario
      • Brampton, Ontario, Canada, L6Y 2R2
        • Pfizer Investigational Site
      • Etobicoke, Ontario, Canada, M9W 6V1
        • Pfizer Investigational Site
      • Kitchener, Ontario, Canada, N2G 1G1
        • Pfizer Investigational Site
      • Mississauga, Ontario, Canada, L5B 4M4
        • Pfizer Investigational Site
      • Newmarket, Ontario, Canada, L3Y 5G8
        • Pfizer Investigational Site
      • Parry Sound, Ontario, Canada, P2A 3A4
        • Pfizer Investigational Site
      • Toronto, Ontario, Canada, M6J 3S3
        • Pfizer Investigational Site
      • Toronto, Ontario, Canada, M5T 3A9
        • Pfizer Investigational Site
      • Toronto, Ontario, Canada, M4P 1P2
        • Pfizer Investigational Site
      • Toronto, Ontario, Canada, M3K 2A7
        • Pfizer Investigational Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35213
        • Pfizer Investigational Site
    • Arizona
      • Phoenix, Arizona, United States, 85023
        • Pfizer Investigational Site
      • Phoenix, Arizona, United States, 85059
        • Pfizer Investigational Site
      • Scottsdale, Arizona, United States, 85254
        • Pfizer Investigational Site
      • Tucson, Arizona, United States, 85712
        • Pfizer Investigational Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Pfizer Investigational Site
    • California
      • Encino, California, United States, 91316
        • Pfizer Investigational Site
      • Garden Grove, California, United States, 92845
        • Pfizer Investigational Site
      • Los Alamitos, California, United States, 90720
        • Pfizer Investigational Site
      • Newport Beach, California, United States, 92660
        • Pfizer Investigational Site
      • Redlands, California, United States, 92374
        • Pfizer Investigational Site
      • San Diego, California, United States, 92108
        • Pfizer Investigational Site
      • San Diego, California, United States, 92120
        • Pfizer Investigational Site
      • San Diego, California, United States, 92103
        • Pfizer Investigational Site
      • Sherman Oaks, California, United States, 91403
        • Pfizer Investigational Site
    • Colorado
      • Colorado Springs, Colorado, United States, 80909
        • Pfizer Investigational Site
    • Florida
      • Brooksville, Florida, United States, 34613
        • Pfizer Investigational Site
      • Deland, Florida, United States, 32720
        • Pfizer Investigational Site
      • Hallandale Beach, Florida, United States, 33009
        • Pfizer Investigational Site
      • Hallandale Beach, Florida, United States, 330009
        • Pfizer Investigational Site
      • Jacksonville, Florida, United States, 32216
        • Pfizer Investigational Site
      • Jupiter, Florida, United States, 33458
        • Pfizer Investigational Site
      • Maitland, Florida, United States, 32751
        • Pfizer Investigational Site
      • Miami, Florida, United States, 33143
        • Pfizer Investigational Site
      • Orlando, Florida, United States, 32806
        • Pfizer Investigational Site
      • Pembroke Pines, Florida, United States, 33026
        • Pfizer Investigational Site
      • Spring Hill, Florida, United States, 34609
        • Pfizer Investigational Site
      • Tampa, Florida, United States, 33614
        • Pfizer Investigational Site
      • Tampa, Florida, United States, 33613
        • Pfizer Investigational Site
      • Tampa, Florida, United States, 33609
        • Pfizer Investigational Site
      • Tampa, Florida, United States, 33609-4052
        • Pfizer Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Pfizer Investigational Site
      • Atlanta, Georgia, United States, 30328
        • Pfizer Investigational Site
      • Gainsville, Georgia, United States, 30501
        • Pfizer Investigational Site
      • Macon, Georgia, United States, 31201
        • Pfizer Investigational Site
    • Illinois
      • Arlington Heights, Illinois, United States, 60004
        • Pfizer Investigational Site
      • Chicago, Illinois, United States, 60607
        • Pfizer Investigational Site
      • Chicago, Illinois, United States, 60622
        • Pfizer Investigational Site
    • Indiana
      • Evansville, Indiana, United States, 47714
        • Pfizer Investigational Site
      • Newburgh, Indiana, United States, 47630
        • Pfizer Investigational Site
    • Kentucky
      • Lexington, Kentucky, United States, 40504
        • Pfizer Investigational Site
      • Mount Sterlingg, Kentucky, United States, 40353
        • Pfizer Investigational Site
      • Mt. Sterling, Kentucky, United States, 40353
        • Pfizer Investigational Site
    • Maryland
      • Chevy Chase, Maryland, United States, 20815
        • Pfizer Investigational Site
    • Michigan
      • Ann Arbor, Michigan, United States, 48104
        • Pfizer Investigational Site
      • Kalamazoo, Michigan, United States, 49009
        • Pfizer Investigational Site
      • St. Clair Shores, Michigan, United States, 48081
        • Pfizer Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87108
        • Pfizer Investigational Site
    • New York
      • New York, New York, United States, 10019
        • Pfizer Investigational Site
      • Staten Island, New York, United States, 10312
        • Pfizer Investigational Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • Pfizer Investigational Site
      • Durham, North Carolina, United States, 27710
        • Pfizer Investigational Site
      • Winston-Salem, North Carolina, United States, 27103
        • Pfizer Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States, 45245
        • Pfizer Investigational Site
      • Cleveland, Ohio, United States, 44122
        • Pfizer Investigational Site
      • Columbus, Ohio, United States, 43213
        • Pfizer Investigational Site
      • Dayton, Ohio, United States, 45408
        • Pfizer Investigational Site
      • Kettering, Ohio, United States, 45429
        • Pfizer Investigational Site
      • Toledo, Ohio, United States, 43623
        • Pfizer Investigational Site
    • Oregon
      • Portland, Oregon, United States, 97239
        • Pfizer Investigational Site
    • Rhode Island
      • East Providence, Rhode Island, United States, 02914
        • Pfizer Investigational Site
    • South Carolina
      • Charleston, South Carolina, United States, 29407
        • Pfizer Investigational Site
    • Tennessee
      • Memphis, Tennessee, United States, 38117
        • Pfizer Investigational Site
    • Texas
      • Austin, Texas, United States, 78756
        • Pfizer Investigational Site
      • Austin, Texas, United States, 78754
        • Pfizer Investigational Site
      • Dallas, Texas, United States, 75230
        • Pfizer Investigational Site
      • Houston, Texas, United States, 77024
        • Pfizer Investigational Site
      • Houston, Texas, United States, 77063
        • Pfizer Investigational Site
      • San Antonio, Texas, United States, 78229
        • Pfizer Investigational Site
    • Virginia
      • Newport News, Virginia, United States, 23606
        • Pfizer Investigational Site
    • Washington
      • Seattle, Washington, United States, 98104
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 3 month history of primary insomnia;
  • 18 to 64 years
  • For the last 3 months-regularly awake unrefreshed and unrestored
  • Difficulty initiating and maintaining sleep for at least 3 nights/week for the past month (difficulty falling asleep, difficulty staying asleep, early awakening)

Exclusion Criteria:

  • Any history of an Axis 1 psychiatric diagnosis;
  • History or presence of any breathing related sleep disorder;
  • History or presence of any medical or neurological condition that could interfere with sleep
  • Use of alcohol as a sleep aid or more than 2 standard drinks consumed per day or more than 14 consumed per week

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 15 mg PD 0200390
Drug: PD 0200390
Capsules, 15 mg, 3 capsules each night before bedtime, Duration - Visit 3-7 for 28 days
Drug: PD 0200390
Capsules, 30 mg, 3 capsules each night before bedtime; Duration - Visit 3-7 for 28 days
Drug: PD 0200390
Capsules, 45 mg, 3 capsules each night before bedtime, Duration- Visit 3-7 for 28 days
Drug: PD 0200390
Capsules, 60 mg, 3 capsules each night before bedtime, Duration - Visit 3-7 for 28 days
Experimental: 30 mg PD 0200390
Drug: PD 0200390
Capsules, 15 mg, 3 capsules each night before bedtime, Duration - Visit 3-7 for 28 days
Drug: PD 0200390
Capsules, 30 mg, 3 capsules each night before bedtime; Duration - Visit 3-7 for 28 days
Drug: PD 0200390
Capsules, 45 mg, 3 capsules each night before bedtime, Duration- Visit 3-7 for 28 days
Drug: PD 0200390
Capsules, 60 mg, 3 capsules each night before bedtime, Duration - Visit 3-7 for 28 days
Experimental: 45 mg PD 0200390
Drug: PD 0200390
Capsules, 15 mg, 3 capsules each night before bedtime, Duration - Visit 3-7 for 28 days
Drug: PD 0200390
Capsules, 30 mg, 3 capsules each night before bedtime; Duration - Visit 3-7 for 28 days
Drug: PD 0200390
Capsules, 45 mg, 3 capsules each night before bedtime, Duration- Visit 3-7 for 28 days
Drug: PD 0200390
Capsules, 60 mg, 3 capsules each night before bedtime, Duration - Visit 3-7 for 28 days
Experimental: 60 mg PD 0200390
Drug: PD 0200390
Capsules, 15 mg, 3 capsules each night before bedtime, Duration - Visit 3-7 for 28 days
Drug: PD 0200390
Capsules, 30 mg, 3 capsules each night before bedtime; Duration - Visit 3-7 for 28 days
Drug: PD 0200390
Capsules, 45 mg, 3 capsules each night before bedtime, Duration- Visit 3-7 for 28 days
Drug: PD 0200390
Capsules, 60 mg, 3 capsules each night before bedtime, Duration - Visit 3-7 for 28 days
Experimental: Placebo PD 0200390
Drug: Placebo
Matched oral placebo for weeks 2-7.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To demonstrate efficacy and characterize the dose response relationship of PD 0200390 on subjective wake after sleep onset in subjects with primary insomnia.
Time Frame: Weekly
Weekly

Secondary Outcome Measures

Outcome Measure
Time Frame
To characterize the dose response relationship of PD 0200390 on functional outcome measures in subjects with primary insomnia.
Time Frame: Weekly
Weekly
To characterize the exposure response relationship of safety & efficacy parameters following administration of PD 0200390 in subjects with primary insomnia.
Time Frame: Weekly
Weekly
To investigate the potential for rebound insomnia and withdrawal effects after discontinuation of PD 0200390 in subjects with primary insomnia.
Time Frame: Weekly
Weekly
To characterize the dose response relationship of PD 0200390 on subjective assessments of latency to sleep onset (LSO), number of awakenings after sleep onset (sNAASO) and total sleep time (sTST) in subjects with primary insomnia.
Time Frame: Weekly
Weekly
To investigate the safety and tolerability of PD 0200390 administered once daily before bedtime in subjects with primary insomnia.
Time Frame: Weekly
Weekly

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

December 6, 2007

First Submitted That Met QC Criteria

December 6, 2007

First Posted (Estimate)

December 10, 2007

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A4251037

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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