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NCT00569972 Clinical Trial

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

Insomnia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00569972
Other study ID # A4251037
Secondary ID
Status Completed
Phase Phase 2
First received December 6, 2007
Last updated July 17, 2012
Start date October 2007
Est. completion date January 2009

Study information
Verified date July 2012
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 682
Est. completion date January 2009
Est. primary completion date January 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 64 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Canada Pfizer Investigational Site Brampton Ontario
Canada Pfizer Investigational Site Calgary Alberta
Canada Pfizer Investigational Site Etobicoke Ontario
Canada Pfizer Investigational Site Kelowna British Columbia
Canada Pfizer Investigational Site Kitchener Ontario
Canada Pfizer Investigational Site Mississauga Ontario
Canada Pfizer Investigational Site Newmarket Ontario
Canada Pfizer Investigational Site Parry Sound Ontario
Canada Pfizer Investigational Site Sydney Nova Scotia
Canada Pfizer Investigational Site Toronto Ontario
Canada Pfizer Investigational Site Toronto Ontario
Canada Pfizer Investigational Site Toronto Ontario
Canada Pfizer Investigational Site Toronto Ontario
United States Pfizer Investigational Site Albuquerque New Mexico
United States Pfizer Investigational Site Ann Arbor Michigan
United States Pfizer Investigational Site Arlington Heights Illinois
United States Pfizer Investigational Site Atlanta Georgia
United States Pfizer Investigational Site Atlanta Georgia
United States Pfizer Investigational Site Austin Texas
United States Pfizer Investigational Site Austin Texas
United States Pfizer Investigational Site Birmingham Alabama
United States Pfizer Investigational Site Brooksville Florida
United States Pfizer Investigational Site Charleston South Carolina
United States Pfizer Investigational Site Charlotte North Carolina
United States Pfizer Investigational Site Chevy Chase Maryland
United States Pfizer Investigational Site Chicago Illinois
United States Pfizer Investigational Site Chicago Illinois
United States Pfizer Investigational Site Cincinnati Ohio
United States Pfizer Investigational Site Cleveland Ohio
United States Pfizer Investigational Site Colorado Springs Colorado
United States Pfizer Investigational Site Columbus Ohio
United States Pfizer Investigational Site Dallas Texas
United States Pfizer Investigational Site Dayton Ohio
United States Pfizer Investigational Site Deland Florida
United States Pfizer Investigational Site Durham North Carolina
United States Pfizer Investigational Site East Providence Rhode Island
United States Pfizer Investigational Site Encino California
United States Pfizer Investigational Site Evansville Indiana
United States Pfizer Investigational Site Gainsville Georgia
United States Pfizer Investigational Site Garden Grove California
United States Pfizer Investigational Site Hallandale Beach Florida
United States Pfizer Investigational Site Hallandale Beach Florida
United States Pfizer Investigational Site Houston Texas
United States Pfizer Investigational Site Houston Texas
United States Pfizer Investigational Site Jacksonville Florida
United States Pfizer Investigational Site Jupiter Florida
United States Pfizer Investigational Site Kalamazoo Michigan
United States Pfizer Investigational Site Kettering Ohio
United States Pfizer Investigational Site Lexington Kentucky
United States Pfizer Investigational Site Little Rock Arkansas
United States Pfizer Investigational Site Los Alamitos California
United States Pfizer Investigational Site Macon Georgia
United States Pfizer Investigational Site Maitland Florida
United States Pfizer Investigational Site Memphis Tennessee
United States Pfizer Investigational Site Miami Florida
United States Pfizer Investigational Site Mount Sterlingg Kentucky
United States Pfizer Investigational Site Mt. Sterling Kentucky
United States Pfizer Investigational Site New York New York
United States Pfizer Investigational Site Newburgh Indiana
United States Pfizer Investigational Site Newport Beach California
United States Pfizer Investigational Site Newport News Virginia
United States Pfizer Investigational Site Orlando Florida
United States Pfizer Investigational Site Pembroke Pines Florida
United States Pfizer Investigational Site Phoenix Arizona
United States Pfizer Investigational Site Phoenix Arizona
United States Pfizer Investigational Site Portland Oregon
United States Pfizer Investigational Site Redlands California
United States Pfizer Investigational Site San Antonio Texas
United States Pfizer Investigational Site San Diego California
United States Pfizer Investigational Site San Diego California
United States Pfizer Investigational Site San Diego California
United States Pfizer Investigational Site Scottsdale Arizona
United States Pfizer Investigational Site Seattle Washington
United States Pfizer Investigational Site Sherman Oaks California
United States Pfizer Investigational Site Spring Hill Florida
United States Pfizer Investigational Site St. Clair Shores Michigan
United States Pfizer Investigational Site Staten Island New York
United States Pfizer Investigational Site Tampa Florida
United States Pfizer Investigational Site Tampa Florida
United States Pfizer Investigational Site Tampa Florida
United States Pfizer Investigational Site Tampa Florida
United States Pfizer Investigational Site Toledo Ohio
United States Pfizer Investigational Site Tucson Arizona
United States Pfizer Investigational Site Winston-Salem North Carolina

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary To demonstrate efficacy and characterize the dose response relationship of PD 0200390 on subjective wake after sleep onset in subjects with primary insomnia. Weekly No
Secondary To characterize the dose response relationship of PD 0200390 on functional outcome measures in subjects with primary insomnia. Weekly No
Secondary To characterize the exposure response relationship of safety & efficacy parameters following administration of PD 0200390 in subjects with primary insomnia. Weekly Yes
Secondary To investigate the potential for rebound insomnia and withdrawal effects after discontinuation of PD 0200390 in subjects with primary insomnia. Weekly No
Secondary 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 No
Secondary To investigate the safety and tolerability of PD 0200390 administered once daily before bedtime in subjects with primary insomnia. Weekly Yes
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Not yet recruiting NCT06363799 - Osteopathic Protocol for Insomnia in College Students N/A
Not yet recruiting NCT06025968 - Digital Cognitive-behavioral Therapy for Insomnia for Patients With Multiple Sclerosis N/A
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