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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00569972
First received: December 6, 2007
Last updated: July 17, 2012
Last verified: July 2012
  Purpose

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


Condition Intervention Phase
Insomnia
Drug: PD 0200390
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: PD 0200390 Dose Ranging Trial: A Randomized, Double Blind, Parallel Group, Placebo Controlled, Multicenter Outpatient Trial Of PD 0200390 In Adults With Primary Insomnia

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To characterize the dose response relationship of PD 0200390 on functional outcome measures in subjects with primary insomnia. [ Time Frame: Weekly ] [ Designated as safety issue: No ]
  • To characterize the exposure response relationship of safety & efficacy parameters following administration of PD 0200390 in subjects with primary insomnia. [ Time Frame: Weekly ] [ Designated as safety issue: Yes ]
  • To investigate the potential for rebound insomnia and withdrawal effects after discontinuation of PD 0200390 in subjects with primary insomnia. [ Time Frame: Weekly ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • To investigate the safety and tolerability of PD 0200390 administered once daily before bedtime in subjects with primary insomnia. [ Time Frame: Weekly ] [ Designated as safety issue: Yes ]

Enrollment: 682
Study Start Date: October 2007
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 15 mg PD 0200390 Drug: PD 0200390
Capsules, 15 mg, 3 capsules each night before bedtime, Duration - Visit 3-7 for 28 days
Experimental: 30 mg PD 0200390 Drug: PD 0200390
Capsules, 30 mg, 3 capsules each night before bedtime; Duration - Visit 3-7 for 28 days
Experimental: 45 mg PD 0200390 Drug: PD 0200390
Capsules, 45 mg, 3 capsules each night before bedtime, Duration- Visit 3-7 for 28 days
Experimental: 60 mg PD 0200390 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.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00569972

  Hide Study Locations
Locations
United States, Alabama
Pfizer Investigational Site
Birmingham, Alabama, United States, 35213
United States, Arizona
Pfizer Investigational Site
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
United States, Arkansas
Pfizer Investigational Site
Little Rock, Arkansas, United States, 72205
United States, California
Pfizer Investigational Site
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, 92120
Pfizer Investigational Site
San Diego, California, United States, 92103
Pfizer Investigational Site
San Diego, California, United States, 92108
Pfizer Investigational Site
Sherman Oaks, California, United States, 91403
United States, Colorado
Pfizer Investigational Site
Colorado Springs, Colorado, United States, 80909
United States, Florida
Pfizer Investigational Site
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, 33609-4052
Pfizer Investigational Site
Tampa, Florida, United States, 33609
United States, Georgia
Pfizer Investigational Site
Atlanta, Georgia, United States, 30342
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Atlanta, Georgia, United States, 30328
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Gainsville, Georgia, United States, 30501
Pfizer Investigational Site
Macon, Georgia, United States, 31201
United States, Illinois
Pfizer Investigational Site
Arlington Heights, Illinois, United States, 60004
Pfizer Investigational Site
Chicago, Illinois, United States, 60622
Pfizer Investigational Site
Chicago, Illinois, United States, 60607
United States, Indiana
Pfizer Investigational Site
Evansville, Indiana, United States, 47714
Pfizer Investigational Site
Newburgh, Indiana, United States, 47630
United States, Kentucky
Pfizer Investigational Site
Lexington, Kentucky, United States, 40504
Pfizer Investigational Site
Mount Sterlingg, Kentucky, United States, 40353
Pfizer Investigational Site
Mt. Sterling, Kentucky, United States, 40353
United States, Maryland
Pfizer Investigational Site
Chevy Chase, Maryland, United States, 20815
United States, Michigan
Pfizer Investigational Site
Ann Arbor, Michigan, United States, 48104
Pfizer Investigational Site
Kalamazoo, Michigan, United States, 49009
Pfizer Investigational Site
St. Clair Shores, Michigan, United States, 48081
United States, New Mexico
Pfizer Investigational Site
Albuquerque, New Mexico, United States, 87108
United States, New York
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New York, New York, United States, 10019
Pfizer Investigational Site
Staten Island, New York, United States, 10312
United States, North Carolina
Pfizer Investigational Site
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
United States, Ohio
Pfizer Investigational Site
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
United States, Oregon
Pfizer Investigational Site
Portland, Oregon, United States, 97239
United States, Rhode Island
Pfizer Investigational Site
East Providence, Rhode Island, United States, 02914
United States, South Carolina
Pfizer Investigational Site
Charleston, South Carolina, United States, 29407
United States, Tennessee
Pfizer Investigational Site
Memphis, Tennessee, United States, 38117
United States, Texas
Pfizer Investigational Site
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
United States, Virginia
Pfizer Investigational Site
Newport News, Virginia, United States, 23606
United States, Washington
Pfizer Investigational Site
Seattle, Washington, United States, 98104
Canada, Alberta
Pfizer Investigational Site
Calgary, Alberta, Canada, T2X 2A8
Canada, British Columbia
Pfizer Investigational Site
Kelowna, British Columbia, Canada, V1Y 2H4
Canada, Nova Scotia
Pfizer Investigational Site
Sydney, Nova Scotia, Canada, B1P 1C6
Canada, Ontario
Pfizer Investigational Site
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
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00569972     History of Changes
Other Study ID Numbers: A4251037
Study First Received: December 6, 2007
Last Updated: July 17, 2012
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on November 27, 2014