Back to resultsA Randomized, Double Blind, Parallel Group, Placebo Controlled, Multicenter Outpatient Trial Of PD 0200390 In Adults With Primary Insomnia
Primary Purpose
Insomnia
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
PD 0200390
PD 0200390
PD 0200390
PD 0200390
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Insomnia
Eligibility 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
Sites / Locations
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
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- Pfizer Investigational Site
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- Pfizer Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
15 mg PD 0200390
30 mg PD 0200390
45 mg PD 0200390
60 mg PD 0200390
Placebo PD 0200390
Arm Description
Outcomes
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.
Secondary Outcome Measures
To characterize the dose response relationship of PD 0200390 on functional outcome measures in subjects with primary insomnia.
To characterize the exposure response relationship of safety & efficacy parameters following administration of PD 0200390 in subjects with primary insomnia.
To investigate the potential for rebound insomnia and withdrawal effects after discontinuation of PD 0200390 in subjects with primary insomnia.
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.
To investigate the safety and tolerability of PD 0200390 administered once daily before bedtime in subjects with primary insomnia.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00569972
Brief Title
A Randomized, Double Blind, Parallel Group, Placebo Controlled, Multicenter Outpatient Trial Of PD 0200390 In Adults With Primary Insomnia
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
682 (Actual)
8. Arms, Groups, and Interventions
Arm Title
15 mg PD 0200390
Arm Type
Experimental
Arm Title
30 mg PD 0200390
Arm Type
Experimental
Arm Title
45 mg PD 0200390
Arm Type
Experimental
Arm Title
60 mg PD 0200390
Arm Type
Experimental
Arm Title
Placebo PD 0200390
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
PD 0200390
Intervention Description
Capsules, 15 mg, 3 capsules each night before bedtime, Duration - Visit 3-7 for 28 days
Intervention Type
Drug
Intervention Name(s)
PD 0200390
Intervention Description
Capsules, 30 mg, 3 capsules each night before bedtime; Duration - Visit 3-7 for 28 days
Intervention Type
Drug
Intervention Name(s)
PD 0200390
Intervention Description
Capsules, 45 mg, 3 capsules each night before bedtime, Duration- Visit 3-7 for 28 days
Intervention Type
Drug
Intervention Name(s)
PD 0200390
Intervention Description
Capsules, 60 mg, 3 capsules each night before bedtime, Duration - Visit 3-7 for 28 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matched oral placebo for weeks 2-7.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
To characterize the dose response relationship of PD 0200390 on functional outcome measures in subjects with primary insomnia.
Time Frame
Weekly
Title
To characterize the exposure response relationship of safety & efficacy parameters following administration of PD 0200390 in subjects with primary insomnia.
Time Frame
Weekly
Title
To investigate the potential for rebound insomnia and withdrawal effects after discontinuation of PD 0200390 in subjects with primary insomnia.
Time Frame
Weekly
Title
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
Title
To investigate the safety and tolerability of PD 0200390 administered once daily before bedtime in subjects with primary insomnia.
Time Frame
Weekly
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35213
Country
United States
Facility Name
Pfizer Investigational Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85023
Country
United States
Facility Name
Pfizer Investigational Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85059
Country
United States
Facility Name
Pfizer Investigational Site
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85254
Country
United States
Facility Name
Pfizer Investigational Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Pfizer Investigational Site
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Pfizer Investigational Site
City
Encino
State/Province
California
ZIP/Postal Code
91316
Country
United States
Facility Name
Pfizer Investigational Site
City
Garden Grove
State/Province
California
ZIP/Postal Code
92845
Country
United States
Facility Name
Pfizer Investigational Site
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720
Country
United States
Facility Name
Pfizer Investigational Site
City
Newport Beach
State/Province
California
ZIP/Postal Code
92660
Country
United States
Facility Name
Pfizer Investigational Site
City
Redlands
State/Province
California
ZIP/Postal Code
92374
Country
United States
Facility Name
Pfizer Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Pfizer Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Pfizer Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
Pfizer Investigational Site
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403
Country
United States
Facility Name
Pfizer Investigational Site
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
Facility Name
Pfizer Investigational Site
City
Brooksville
State/Province
Florida
ZIP/Postal Code
34613
Country
United States
Facility Name
Pfizer Investigational Site
City
Deland
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Pfizer Investigational Site
City
Hallandale Beach
State/Province
Florida
ZIP/Postal Code
330009
Country
United States
Facility Name
Pfizer Investigational Site
City
Hallandale Beach
State/Province
Florida
ZIP/Postal Code
33009
Country
United States
Facility Name
Pfizer Investigational Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Pfizer Investigational Site
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Facility Name
Pfizer Investigational Site
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Pfizer Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Pfizer Investigational Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Pfizer Investigational Site
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33026
Country
United States
Facility Name
Pfizer Investigational Site
City
Spring Hill
State/Province
Florida
ZIP/Postal Code
34609
Country
United States
Facility Name
Pfizer Investigational Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609-4052
Country
United States
Facility Name
Pfizer Investigational Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
Pfizer Investigational Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Pfizer Investigational Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
Pfizer Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Pfizer Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Pfizer Investigational Site
City
Gainsville
State/Province
Georgia
ZIP/Postal Code
30501
Country
United States
Facility Name
Pfizer Investigational Site
City
Macon
State/Province
Georgia
ZIP/Postal Code
31201
Country
United States
Facility Name
Pfizer Investigational Site
City
Arlington Heights
State/Province
Illinois
ZIP/Postal Code
60004
Country
United States
Facility Name
Pfizer Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60607
Country
United States
Facility Name
Pfizer Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60622
Country
United States
Facility Name
Pfizer Investigational Site
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
Pfizer Investigational Site
City
Newburgh
State/Province
Indiana
ZIP/Postal Code
47630
Country
United States
Facility Name
Pfizer Investigational Site
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40504
Country
United States
Facility Name
Pfizer Investigational Site
City
Mount Sterlingg
State/Province
Kentucky
ZIP/Postal Code
40353
Country
United States
Facility Name
Pfizer Investigational Site
City
Mt. Sterling
State/Province
Kentucky
ZIP/Postal Code
40353
Country
United States
Facility Name
Pfizer Investigational Site
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
Pfizer Investigational Site
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48104
Country
United States
Facility Name
Pfizer Investigational Site
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49009
Country
United States
Facility Name
Pfizer Investigational Site
City
St. Clair Shores
State/Province
Michigan
ZIP/Postal Code
48081
Country
United States
Facility Name
Pfizer Investigational Site
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87108
Country
United States
Facility Name
Pfizer Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
Facility Name
Pfizer Investigational Site
City
Staten Island
State/Province
New York
ZIP/Postal Code
10312
Country
United States
Facility Name
Pfizer Investigational Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Pfizer Investigational Site
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Pfizer Investigational Site
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Pfizer Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45245
Country
United States
Facility Name
Pfizer Investigational Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Pfizer Investigational Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Facility Name
Pfizer Investigational Site
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45408
Country
United States
Facility Name
Pfizer Investigational Site
City
Kettering
State/Province
Ohio
ZIP/Postal Code
45429
Country
United States
Facility Name
Pfizer Investigational Site
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43623
Country
United States
Facility Name
Pfizer Investigational Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Pfizer Investigational Site
City
East Providence
State/Province
Rhode Island
ZIP/Postal Code
02914
Country
United States
Facility Name
Pfizer Investigational Site
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29407
Country
United States
Facility Name
Pfizer Investigational Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38117
Country
United States
Facility Name
Pfizer Investigational Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78754
Country
United States
Facility Name
Pfizer Investigational Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
Facility Name
Pfizer Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Pfizer Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Facility Name
Pfizer Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77063
Country
United States
Facility Name
Pfizer Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Pfizer Investigational Site
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23606
Country
United States
Facility Name
Pfizer Investigational Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Pfizer Investigational Site
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2X 2A8
Country
Canada
Facility Name
Pfizer Investigational Site
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 2H4
Country
Canada
Facility Name
Pfizer Investigational Site
City
Sydney
State/Province
Nova Scotia
ZIP/Postal Code
B1P 1C6
Country
Canada
Facility Name
Pfizer Investigational Site
City
Brampton
State/Province
Ontario
ZIP/Postal Code
L6Y 2R2
Country
Canada
Facility Name
Pfizer Investigational Site
City
Etobicoke
State/Province
Ontario
ZIP/Postal Code
M9W 6V1
Country
Canada
Facility Name
Pfizer Investigational Site
City
Kitchener
State/Province
Ontario
ZIP/Postal Code
N2G 1G1
Country
Canada
Facility Name
Pfizer Investigational Site
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5B 4M4
Country
Canada
Facility Name
Pfizer Investigational Site
City
Newmarket
State/Province
Ontario
ZIP/Postal Code
L3Y 5G8
Country
Canada
Facility Name
Pfizer Investigational Site
City
Parry Sound
State/Province
Ontario
ZIP/Postal Code
P2A 3A4
Country
Canada
Facility Name
Pfizer Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3K 2A7
Country
Canada
Facility Name
Pfizer Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4P 1P2
Country
Canada
Facility Name
Pfizer Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 3A9
Country
Canada
Facility Name
Pfizer Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6J 3S3
Country
Canada
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A4251037&StudyName=%20A%20Randomized%2C%20Double%20Blind%2C%20Parallel%20Group%2C%20Placebo%20Controlled%2C%20Multicenter%20Outpatient%20Trial%20Of%20PD%200200390%20In%20Adults%20With%20Primary
Description
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Learn more about this trial
A Randomized, Double Blind, Parallel Group, Placebo Controlled, Multicenter Outpatient Trial Of PD 0200390 In Adults With Primary Insomnia
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