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

NCT00569972 | Completed Phase 2

• 1 other identifier: A4251037
• Study Type: interventional
• Target: 682
• Locations: 2 countries
• Sites: 84

Brief Summary

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

Conditions

Insomnia

Outcome Measures

Primary Outcomes (1)

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

  Weekly

Secondary Outcomes (5)

• To characterize the dose response relationship of PD 0200390 on functional outcome measures in subjects with primary insomnia.

  Weekly

• To characterize the exposure response relationship of safety & efficacy parameters following administration of PD 0200390 in subjects with primary insomnia.

  Weekly

• To investigate the potential for rebound insomnia and withdrawal effects after discontinuation of PD 0200390 in subjects with primary insomnia.

  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.

  Weekly

• To investigate the safety and tolerability of PD 0200390 administered once daily before bedtime in subjects with primary insomnia.

  Weekly

Study Arms (5)

15 mg PD 0200390

EXPERIMENTAL

Drug: PD 0200390

30 mg PD 0200390

EXPERIMENTAL

Drug: PD 0200390

45 mg PD 0200390

EXPERIMENTAL

Drug: PD 0200390

60 mg PD 0200390

EXPERIMENTAL

Drug: PD 0200390

Placebo PD 0200390

EXPERIMENTAL

Drug: Placebo

Interventions

PD 0200390 DRUG

Capsules, 15 mg, 3 capsules each night before bedtime, Duration - Visit 3-7 for 28 days

15 mg PD 0200390

Placebo DRUG

Matched oral placebo for weeks 2-7.

Placebo PD 0200390

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• month history of primary insomnia;
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (84)

Pfizer Investigational Site

Birmingham, Alabama, 35213, United States

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Phoenix, Arizona, 85023, United States

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Phoenix, Arizona, 85059, United States

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Scottsdale, Arizona, 85254, United States

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Tucson, Arizona, 85712, United States

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Little Rock, Arkansas, 72205, United States

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Encino, California, 91316, United States

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Garden Grove, California, 92845, United States

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Los Alamitos, California, 90720, United States

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Newport Beach, California, 92660, United States

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Redlands, California, 92374, United States

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San Diego, California, 92103, United States

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San Diego, California, 92108, United States

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San Diego, California, 92120, United States

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Sherman Oaks, California, 91403, United States

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Colorado Springs, Colorado, 80909, United States

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Brooksville, Florida, 34613, United States

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DeLand, Florida, 32720, United States

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Hallandale, Florida, 330009, United States

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Hallandale, Florida, 33009, United States

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Jacksonville, Florida, 32216, United States

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Jupiter, Florida, 33458, United States

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Maitland, Florida, 32751, United States

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Miami, Florida, 33143, United States

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Orlando, Florida, 32806, United States

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Pembroke Pines, Florida, 33026, United States

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Spring Hill, Florida, 34609, United States

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Tampa, Florida, 33609-4052, United States

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Tampa, Florida, 33609, United States

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Tampa, Florida, 33613, United States

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Tampa, Florida, 33614, United States

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Atlanta, Georgia, 30328, United States

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Atlanta, Georgia, 30342, United States

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Gainsville, Georgia, 30501, United States

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Macon, Georgia, 31201, United States

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Arlington Heights, Illinois, 60004, United States

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Chicago, Illinois, 60607, United States

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Chicago, Illinois, 60622, United States

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Evansville, Indiana, 47714, United States

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Newburgh, Indiana, 47630, United States

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Lexington, Kentucky, 40504, United States

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Mount Sterling, Kentucky, 40353, United States

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Mount Sterlingg, Kentucky, 40353, United States

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Chevy Chase, Maryland, 20815, United States

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Ann Arbor, Michigan, 48104, United States

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Kalamazoo, Michigan, 49009, United States

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Saint Clair Shores, Michigan, 48081, United States

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Albuquerque, New Mexico, 87108, United States

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New York, New York, 10019, United States

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Staten Island, New York, 10312, United States

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Charlotte, North Carolina, 28207, United States

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Durham, North Carolina, 27710, United States

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Winston-Salem, North Carolina, 27103, United States

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Cincinnati, Ohio, 45245, United States

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Cleveland, Ohio, 44122, United States

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Columbus, Ohio, 43213, United States

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Dayton, Ohio, 45408, United States

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Kettering, Ohio, 45429, United States

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Toledo, Ohio, 43623, United States

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Portland, Oregon, 97239, United States

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East Providence, Rhode Island, 02914, United States

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Charleston, South Carolina, 29407, United States

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Memphis, Tennessee, 38117, United States

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Austin, Texas, 78754, United States

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Austin, Texas, 78756, United States

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Dallas, Texas, 75230, United States

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Houston, Texas, 77024, United States

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Houston, Texas, 77063, United States

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San Antonio, Texas, 78229, United States

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Newport News, Virginia, 23606, United States

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Seattle, Washington, 98104, United States

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Calgary, Alberta, T2X 2A8, Canada

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Kelowna, British Columbia, V1Y 2H4, Canada

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Sydney, Nova Scotia, B1P 1C6, Canada

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Brampton, Ontario, L6Y 2R2, Canada

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Etobicoke, Ontario, M9W 6V1, Canada

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Kitchener, Ontario, N2G 1G1, Canada

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Mississauga, Ontario, L5B 4M4, Canada

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Newmarket, Ontario, L3Y 5G8, Canada

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Parry Sound, Ontario, P2A 3A4, Canada

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Toronto, Ontario, M3K 2A7, Canada

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Toronto, Ontario, M4P 1P2, Canada

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Toronto, Ontario, M5T 3A9, Canada

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Toronto, Ontario, M6J 3S3, Canada

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MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

(1-aminomethyl-3,4-dimethylcyclopentyl)acetic acid

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2007
• First Posted: December 10, 2007
• Study Start: October 1, 2007
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: July 25, 2012

Record last verified: 2012-07

Locations

US (71); CA (13)