You are here

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

Last updated on December 16, 2017

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

NCT00569972
Pfizer
Completed
A Randomized, Double Blind, Parallel Group, Placebo Controlled, Multicenter Outpatient Trial Of PD 0200390 In Adults With Primary Insomnia

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your zip code, city, or country to find studies near you.
A Randomized, Double Blind, Parallel Group, Placebo Controlled, Multicenter Outpatient Trial Of PD 0200390 In Adults With Primary Insomnia
PD 0200390 Dose Ranging Trial: A Randomized, Double Blind, Parallel Group, Placebo Controlled, Multicenter Outpatient Trial Of PD 0200390 In Adults With Primary Insomnia
To demonstrate efficacy and characterize the dose response relationship of PD 0200390 on subjective wake after sleep onset in subjects with primary insomnia.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Insomnia
  • 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.
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
682
January 2009
January 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 64 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
 
 
NCT00569972
A4251037
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



Call Now