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PD 0200390

Phase 2

Insomnia | Small molecule | Psychiatry |Pfizer, Inc.|Last Updated: Jul 25, 2012

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials2
Total Enrollment688

FDA Designations

No designations recorded

Clinical trial landscape

PD 0200390 · 4 trials · 3 indications

Phase 2 3Phase 1 1
NCT00655369A Double-blind, Parallel Group, Placebo-Controlled Outpatient Trial of PD 00200390 in Adults With Nonrestorative SleepNonrestorative Sleep
COMPLETED306 Analytics
NCT00551148A Dose-ranging, Multicenter Polysomnography Trial of PD 0200390 in Adults With Primary InsomniaPrimary Insomnia
COMPLETED92 Analytics
NCT00569972A Randomized, Double Blind, Parallel Group, Placebo Controlled, Multicenter Outpatient Trial Of PD 0200390 In Adults With Primary InsomniaInsomnia
COMPLETED682 Analytics
PHASE2COMPLETED
A Double-blind, Parallel Group, Placebo-Controlled Outpatient Trial of PD 00200390 in Adults With Nonrestorative Sleep
Nonrestorative SleepUnlock trial analytics
PHASE2COMPLETED
A Dose-ranging, Multicenter Polysomnography Trial of PD 0200390 in Adults With Primary Insomnia
Primary InsomniaUnlock trial analytics
PHASE2COMPLETED
A Randomized, Double Blind, Parallel Group, Placebo Controlled, Multicenter Outpatient Trial Of PD 0200390 In Adults With Primary Insomnia
InsomniaUnlock trial analytics

Study Endpoints

Primary Endpoints

Total score of how an individual rates the restorative value of his/her sleep in the morning using the weekly version of the Restorative Sleep Questionnaire (RSQ-Weekly)
Weekly
Dose-response relationship of PD 200390 on wake after sleep onset (WASO) in subjects with primary insomnia as determined by Polysomnography
weekly
To demonstrate efficacy and characterize the dose response relationship of PD 0200390 on subjective wake after sleep onset in subjects with primary insomnia.
Weekly
Radioactivity parameters in plasma and whole blood - Cmax , Tmax , AUCinf, AUClast, t1/2, CL/F and V/F and Total 14C data in blood, urine and feces
2 days

Secondary Endpoints

Measure sleep and early morning behavior during treatment using the Leeds Sleep Evaluation Questionnaire
Weeky
Total score of the Daily Restorative Sleep Questionnaire
Daily
Total score of the Multidimensional Assessment of Fatigue (MAF)
Weekly
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
15 mgEXPERIMENTAL -
25 mgEXPERIMENTAL -
35 mgEXPERIMENTAL -
5 mgEXPERIMENTAL -
50 mgEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
30 mgEXPERIMENTAL -
60 mgEXPERIMENTAL -
15 mg PD 0200390EXPERIMENTAL -
30 mg PD 0200390EXPERIMENTAL -
45 mg PD 0200390EXPERIMENTAL -
60 mg PD 0200390EXPERIMENTAL -
Placebo PD 0200390EXPERIMENTAL -
A425EXPERIMENTALA425 Treated

Interventions

NameTypeDescription
PD 0200390DRUGoral 15 mg daily dose, 3 capsules per dose during a six week treatment period.
PlaceboDRUGoral placebo daily dose, 3 capsules per dose during a six week treatment period.
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Eligibility Criteria

Age Range18 Years to 64 Years
SexALL
Healthy VolunteersNo
Study Sites59

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 min...

Countries:United StatesCanada
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Competitive Landscape -Insomnia and Sleep Disorders 11 trials (matched to "Insomnia")

Frequently asked questions about PD 0200390

What is PD 0200390 used for?

PD 0200390 is an investigational small molecule being developed for primary insomnia, insomnia, and nonrestorative sleep. It has been studied in Phase 2 clinical trials in adults with these sleep conditions.

Who is developing PD 0200390?

PD 0200390 is being developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. The drug is a small molecule in the psychiatry therapeutic area.

What phase is PD 0200390 in?

PD 0200390 is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. All completed trials for the drug are Phase 2 trials.

What clinical trials has PD 0200390 been in?

PD 0200390 has been studied in several completed trials. NCT00551148 was a dose-ranging polysomnography trial in primary insomnia with 92 participants. NCT00569972 was a randomized, double-blind, placebo-controlled outpatient trial in insomnia with 682 participants. NCT00655369 was a placebo-controlled trial in nonrestorative sleep with 306 participants.

Is PD 0200390 the same as PD 00200390?

PD 0200390 and PD 00200390 appear to refer to the same drug. A clinical trial listed as NCT00655369 uses the name PD 00200390 and studies the same condition of nonrestorative sleep in adults.