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

Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT00569972
Collaborator
(none)
682
Enrollment
84
Locations
5
Arms
15
Duration (Months)
8.1
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: PD 0200390
  • Drug: PD 0200390
  • Drug: PD 0200390
  • Drug: PD 0200390
  • Drug: Placebo
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
682 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, 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
Study Start Date :
Oct 1, 2007
Actual Primary Completion Date :
Jan 1, 2009
Actual Study Completion Date :
Jan 1, 2009

Arms and Interventions

Arm Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

  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 Outcome Measures

  1. To characterize the dose response relationship of PD 0200390 on functional outcome measures in subjects with primary insomnia. [Weekly]

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

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

  4. 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]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 64 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 Pfizer Investigational Site Birmingham Alabama United States 35213
2 Pfizer Investigational Site Phoenix Arizona United States 85023
3 Pfizer Investigational Site Phoenix Arizona United States 85059
4 Pfizer Investigational Site Scottsdale Arizona United States 85254
5 Pfizer Investigational Site Tucson Arizona United States 85712
6 Pfizer Investigational Site Little Rock Arkansas United States 72205
7 Pfizer Investigational Site Encino California United States 91316
8 Pfizer Investigational Site Garden Grove California United States 92845
9 Pfizer Investigational Site Los Alamitos California United States 90720
10 Pfizer Investigational Site Newport Beach California United States 92660
11 Pfizer Investigational Site Redlands California United States 92374
12 Pfizer Investigational Site San Diego California United States 92103
13 Pfizer Investigational Site San Diego California United States 92108
14 Pfizer Investigational Site San Diego California United States 92120
15 Pfizer Investigational Site Sherman Oaks California United States 91403
16 Pfizer Investigational Site Colorado Springs Colorado United States 80909
17 Pfizer Investigational Site Brooksville Florida United States 34613
18 Pfizer Investigational Site Deland Florida United States 32720
19 Pfizer Investigational Site Hallandale Beach Florida United States 330009
20 Pfizer Investigational Site Hallandale Beach Florida United States 33009
21 Pfizer Investigational Site Jacksonville Florida United States 32216
22 Pfizer Investigational Site Jupiter Florida United States 33458
23 Pfizer Investigational Site Maitland Florida United States 32751
24 Pfizer Investigational Site Miami Florida United States 33143
25 Pfizer Investigational Site Orlando Florida United States 32806
26 Pfizer Investigational Site Pembroke Pines Florida United States 33026
27 Pfizer Investigational Site Spring Hill Florida United States 34609
28 Pfizer Investigational Site Tampa Florida United States 33609-4052
29 Pfizer Investigational Site Tampa Florida United States 33609
30 Pfizer Investigational Site Tampa Florida United States 33613
31 Pfizer Investigational Site Tampa Florida United States 33614
32 Pfizer Investigational Site Atlanta Georgia United States 30328
33 Pfizer Investigational Site Atlanta Georgia United States 30342
34 Pfizer Investigational Site Gainsville Georgia United States 30501
35 Pfizer Investigational Site Macon Georgia United States 31201
36 Pfizer Investigational Site Arlington Heights Illinois United States 60004
37 Pfizer Investigational Site Chicago Illinois United States 60607
38 Pfizer Investigational Site Chicago Illinois United States 60622
39 Pfizer Investigational Site Evansville Indiana United States 47714
40 Pfizer Investigational Site Newburgh Indiana United States 47630
41 Pfizer Investigational Site Lexington Kentucky United States 40504
42 Pfizer Investigational Site Mount Sterlingg Kentucky United States 40353
43 Pfizer Investigational Site Mt. Sterling Kentucky United States 40353
44 Pfizer Investigational Site Chevy Chase Maryland United States 20815
45 Pfizer Investigational Site Ann Arbor Michigan United States 48104
46 Pfizer Investigational Site Kalamazoo Michigan United States 49009
47 Pfizer Investigational Site St. Clair Shores Michigan United States 48081
48 Pfizer Investigational Site Albuquerque New Mexico United States 87108
49 Pfizer Investigational Site New York New York United States 10019
50 Pfizer Investigational Site Staten Island New York United States 10312
51 Pfizer Investigational Site Charlotte North Carolina United States 28207
52 Pfizer Investigational Site Durham North Carolina United States 27710
53 Pfizer Investigational Site Winston-Salem North Carolina United States 27103
54 Pfizer Investigational Site Cincinnati Ohio United States 45245
55 Pfizer Investigational Site Cleveland Ohio United States 44122
56 Pfizer Investigational Site Columbus Ohio United States 43213
57 Pfizer Investigational Site Dayton Ohio United States 45408
58 Pfizer Investigational Site Kettering Ohio United States 45429
59 Pfizer Investigational Site Toledo Ohio United States 43623
60 Pfizer Investigational Site Portland Oregon United States 97239
61 Pfizer Investigational Site East Providence Rhode Island United States 02914
62 Pfizer Investigational Site Charleston South Carolina United States 29407
63 Pfizer Investigational Site Memphis Tennessee United States 38117
64 Pfizer Investigational Site Austin Texas United States 78754
65 Pfizer Investigational Site Austin Texas United States 78756
66 Pfizer Investigational Site Dallas Texas United States 75230
67 Pfizer Investigational Site Houston Texas United States 77024
68 Pfizer Investigational Site Houston Texas United States 77063
69 Pfizer Investigational Site San Antonio Texas United States 78229
70 Pfizer Investigational Site Newport News Virginia United States 23606
71 Pfizer Investigational Site Seattle Washington United States 98104
72 Pfizer Investigational Site Calgary Alberta Canada T2X 2A8
73 Pfizer Investigational Site Kelowna British Columbia Canada V1Y 2H4
74 Pfizer Investigational Site Sydney Nova Scotia Canada B1P 1C6
75 Pfizer Investigational Site Brampton Ontario Canada L6Y 2R2
76 Pfizer Investigational Site Etobicoke Ontario Canada M9W 6V1
77 Pfizer Investigational Site Kitchener Ontario Canada N2G 1G1
78 Pfizer Investigational Site Mississauga Ontario Canada L5B 4M4
79 Pfizer Investigational Site Newmarket Ontario Canada L3Y 5G8
80 Pfizer Investigational Site Parry Sound Ontario Canada P2A 3A4
81 Pfizer Investigational Site Toronto Ontario Canada M3K 2A7
82 Pfizer Investigational Site Toronto Ontario Canada M4P 1P2
83 Pfizer Investigational Site Toronto Ontario Canada M5T 3A9
84 Pfizer Investigational Site Toronto Ontario Canada M6J 3S3

Sponsors and Collaborators

  • Pfizer

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT00569972
Other Study ID Numbers:
  • A4251037
First Posted:
Dec 10, 2007
Last Update Posted:
Jul 25, 2012
Last Verified:
Jul 1, 2012
Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders

Study Results

No Results Posted as of Jul 25, 2012