A Dose-Ranging, Multicenter Polysomnography Trial of PD 0200390 in Elderly Subjects With Primary Insomnia
NCT00748592
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- 3 month history of primary insomnia
- Difficulty initiating and maintaining sleep for at least 3 nights/week for the past month (difficulty falling asleep, difficulty staying asleep, early awakening)
- Any history of 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
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- New Haven, Connecticut
- Birmingham, Alabama
- Phoenix, Arizona
- Phoenix, Arizona
- Scottsdale, Arizona
- Tucson, Arizona
- Little Rock, Arkansas
- Encino, California
- Garden Grove, California
- Los Alamitos, California
- Newport Beach, California
- Redlands, California
- San Diego, California
- San Diego, California
- San Diego, California
- Sherman Oaks, California
- Colorado Springs, Colorado
- Brooksville, Florida
- Deland, Florida
- Hallandale Beach, Florida
- Hallandale Beach, Florida
- Jacksonville, Florida
- Jupiter, Florida
- Maitland, Florida
- Miami, Florida
- Orlando, Florida
- Pembroke Pines, Florida
- Spring Hill, Florida
- Tampa, Florida
- Tampa, Florida
- Tampa, Florida
- Tampa, Florida
- Atlanta, Georgia
- Atlanta, Georgia
- Gainsville, Georgia
- Macon, Georgia
- Arlington Heights, Illinois
- Chicago, Illinois
- Chicago, Illinois
- Evansville, Indiana
- Newburgh, Indiana
- Lexington, Kentucky
- Mount Sterlingg, Kentucky
- Mt. Sterling, Kentucky
- Chevy Chase, Maryland
- Ann Arbor, Michigan
- Kalamazoo, Michigan
- St. Clair Shores, Michigan
- Albuquerque, New Mexico
- New York, New York
- Staten Island, New York
- Charlotte, North Carolina
- Durham, North Carolina
- Winston-Salem, North Carolina
- Cincinnati, Ohio
- Cleveland, Ohio
- Columbus, Ohio
- Dayton, Ohio
- Kettering, Ohio
- Toledo, Ohio
- Portland, Oregon
- East Providence, Rhode Island
- Charleston, South Carolina
- Memphis, Tennessee
- Austin, Texas
- Austin, Texas
- Dallas, Texas
- Houston, Texas
- Houston, Texas
- San Antonio, Texas
- Newport News, Virginia
- Seattle, Washington
- Calgary, Alberta
- Kelowna, British Columbia
- Sydney, Nova Scotia
- Brampton, Ontario
- Etobicoke, Ontario
- Kitchener, Ontario
- Mississauga, Ontario
- Newmarket, Ontario
- Parry Sound, Ontario
- Toronto, Ontario
- Toronto, Ontario
- Toronto, Ontario
- Toronto, Ontario
- Miami, Florida
Descriptive Information | ||||
---|---|---|---|---|
Brief Title ICMJE | A Dose-Ranging, Multicenter Polysomnography Trial of PD 0200390 in Elderly Subjects With Primary Insomnia | |||
Official Title ICMJE | PD 0200390 Dose-Ranging Trial: A Randomized, Double-Blind, Placebo-Controlled, 4-Way Crossover, Multicenter Polysomnography Trial Of PD 0200390 In Elderly Subjects With Primary Insomnia | |||
Brief Summary | This is a randomized, double-blind, placebo-controlled, multicenter trial with a 4-way crossover design. Elderly subjects with primary insomnia who meet screening requirements will initially be randomized into the study and receive the first of 4 treatments (PD 0200390 5 mg, 15 mg and 30 mg or placebo) daily 30 minutes before bed time for 2 consecutive days in a polysomnography (PSG) lab. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment | |||
Condition ICMJE | Insomnia | |||
Intervention ICMJE |
| |||
Study Arms ICMJE |
| |||
Publications * | Not Provided | |||
* 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 | Withdrawn | |||
Actual Enrollment ICMJE | 0 | |||
Original Estimated Enrollment ICMJE | 32 | |||
Estimated Study Completion Date ICMJE | June 2009 | |||
Estimated Primary Completion Date | June 2009 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 65 Years and older (Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Not Provided | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00748592 | |||
Other Study ID Numbers ICMJE | A4251026 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc. | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Pfizer | |||
Verification Date | February 2009 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |