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

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NCT00569972

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Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35213, United States
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Contact
1-800-718-1021
[email protected]
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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Insomnia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-64 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Randomized, Double Blind, Parallel Group, Placebo Controlled, Multicenter Outpatient Trial Of PD 0200390 In Adults With Primary Insomnia
Official Title  ICMJE PD 0200390 Dose Ranging Trial: A Randomized, Double Blind, Parallel Group, Placebo Controlled, Multicenter Outpatient Trial Of PD 0200390 In Adults With Primary Insomnia
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Insomnia
Intervention  ICMJE
  • Drug: PD 0200390
    Capsules, 15 mg, 3 capsules each night before bedtime, Duration - Visit 3-7 for 28 days
  • Drug: PD 0200390
    Capsules, 30 mg, 3 capsules each night before bedtime; Duration - Visit 3-7 for 28 days
  • Drug: PD 0200390
    Capsules, 45 mg, 3 capsules each night before bedtime, Duration- Visit 3-7 for 28 days
  • Drug: PD 0200390
    Capsules, 60 mg, 3 capsules each night before bedtime, Duration - Visit 3-7 for 28 days
  • Drug: Placebo
    Matched oral placebo for weeks 2-7.
Study Arms  ICMJE
  • Experimental: 15 mg PD 0200390
    Intervention: Drug: PD 0200390
  • Experimental: 30 mg PD 0200390
    Intervention: Drug: PD 0200390
  • Experimental: 45 mg PD 0200390
    Intervention: Drug: PD 0200390
  • Experimental: 60 mg PD 0200390
    Intervention: Drug: PD 0200390
  • Experimental: Placebo PD 0200390
    Intervention: Drug: Placebo
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 Completed
Actual Enrollment  ICMJE
 (submitted: January 29, 2009)		682
Original Enrollment  ICMJE
 (submitted: December 6, 2007)		650
Actual Study Completion Date  ICMJE January 2009
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00569972
Other Study ID Numbers  ICMJE A4251037
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP