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A Double-blind, Parallel Group, Placebo-Controlled Outpatient Trial of PD 00200390 in Adults With Nonrestorative Sleep

Last updated on May 10, 2018

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Study Location
Pfizer Investigational Site
Glendale, Arizona, 85306 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Nonrestorative Sleep
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

- Awake unrestored or unrefreshed, associated with significant distress or impairment in
social, occupational, or other important areas of functioning during the daytime, for
at least 3 nights for the past 3 months prior to screening

- Self-report wake after sleep onset sleep onset

- PSG (Polysomnography) sleep criteria of wake after sleep onset persistent sleep

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

- MAP (Multivariable Apnea Risk index) index > or = 0.5 at screening

- BMI = or > 32 kg/m2

- History or presence of breathing related disorders

- PSG findings consistent with and periodic limb movement disorder, narcolepsy or other
dyssomnia or parasomnia including apnea-hypopnea index > 10/hr; or period limb
movement with arousal index > 10/hr.

NCT00655369
Pfizer
Completed
A Double-blind, Parallel Group, Placebo-Controlled Outpatient Trial of PD 00200390 in Adults With Nonrestorative Sleep

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A Double-blind, Parallel Group, Placebo-Controlled Outpatient Trial of PD 00200390 in Adults With Nonrestorative Sleep
PD 0200390 Dose-Ranging Trial: A Randomized, Double-Blind, Parallel Group, Placebo-Controlled, Multicenter Outpatient Trial of PD 0200390 in Adults With Nonrestorative Sleep
In a Phase II trial in subjects with nonrestorative sleep, PD 0200390 demonstrated a positive treatment effect relative to placebo on the primary endpoint, the weekly version of the Restorative Sleep Questionnaire (RSQ-W). In this study, the dose-response relationship of varying doses of PD 0200390 using the Restorative Sleep Questionnaire (RSQ-W), will be explored in Nonrestorative Sleep subjects.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Nonrestorative Sleep
  • Drug: PD 0200390
    oral 15 mg daily dose, 3 capsules per dose during a six week treatment period.
  • Drug: PD 0200390
    oral 25 mg daily dose, 3 capsules per dose during a six week treatment period.
  • Drug: PD 0200390
    oral 35 mg daily dose, 3 capsules per dose during a six week treatment period.
  • Drug: PD 0200390
    oral 5 mg daily dose, 3 capsules per dose during a six week treatment period.
  • Drug: PD 0200390
    oral 50 mg daily dose, 3 capsules per dose during a six week treatment period.
  • Drug: Placebo
    oral placebo daily dose, 3 capsules per dose during a six week treatment period.
  • Experimental: 15 mg
    Intervention: Drug: PD 0200390
  • Experimental: 25 mg
    Intervention: Drug: PD 0200390
  • Experimental: 35 mg
    Intervention: Drug: PD 0200390
  • Experimental: 5 mg
    Intervention: Drug: PD 0200390
  • Experimental: 50 mg
    Intervention: Drug: PD 0200390
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Drake CL, Hays RD, Morlock R, Wang F, Shikiar R, Frank L, Downey R, Roth T. Development and evaluation of a measure to assess restorative sleep. J Clin Sleep Med. 2014 Jul 15;10(7):733-41, 741A-741E. doi: 10.5664/jcsm.3860.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
306
December 2008
December 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Awake unrestored or unrefreshed, associated with significant distress or impairment in social, occupational, or other important areas of functioning during the daytime, for at least 3 nights for the past 3 months prior to screening
  • Self-report wake after sleep onset <45 mins for past 3 mos; self-report latency to sleep onset <20 mins for past 3 mos
  • PSG (Polysomnography) sleep criteria of wake after sleep onset < 45 mins; Latency to persistent sleep <20 mins.

Exclusion Criteria:

  • MAP (Multivariable Apnea Risk index) index > or = 0.5 at screening
  • BMI = or > 32 kg/m2
  • History or presence of breathing related disorders
  • PSG findings consistent with and periodic limb movement disorder, narcolepsy or other dyssomnia or parasomnia including apnea-hypopnea index > 10/hr; or period limb movement with arousal index > 10/hr.
Sexes Eligible for Study: All
18 Years to 64 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
 
 
NCT00655369
A4251033
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

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