A Dose-ranging, Multicenter Polysomnography Trial of PD 0200390 in Adults With Primary Insomnia

Phase 2

Completed

• Conditions: Primary Insomnia
• Interventions: Drug: PD 0200390; Other: Placebo

• Registration Number: NCT00551148
• Lead Sponsor: Pfizer

Brief Summary

The purpose of this study is to further explore an effective dose range of PD0200390 for the treatment of patients with insomnia.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2007-10-27
• Study First Submitted QC: 2007-10-27
• Study First Posted: 2007-10-30
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Disposition First Submitted: 2009-03-20
• Disposition First Submitted QC: 2009-09-25
• Disposition First Posted: 2009-09-30
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-17
• Last Update Posted: 2012-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

Inclusion Criteria

3 month history of Primary Insomnia (DSM-IV criteria)

Self report sleep criteria for at least 3 nights per week in past month;

sWASO (subjective wake after sleep onset) equal or greater than 60 mins

sLSO (subjective latency to sleep onset) equal or greater than 45 minutes

TST less than or equal to 6.5 hrs

Maintain normal daytime-awake, nighttime-sleep schedule

PSG sleep criteria of mean WASO equal or greater than 60 mins calculated on 2 PSG screening nights

TST between 3 to 7 hrs on 2 PSG screening nights

Mean LPS (latency to persistent sleep) equal or greater than 20 mins calculated on 2 PSG screening nights

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Exclusion Criteria

Comorbid psychiatric disease or disorders

History or presence of breathing-related disorders

Multivariable Apnea risk index (MAP) equal or greater than 0.5 at screening

History or presence of medical or neurological condition interfering with sleep

Current use of know psychotropic effect medications

Excessive caffeine use

Use of alcohol as a sleep aid or more than 2 standard drinks/day

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
60 mg	PD 0200390	-
15 mg	PD 0200390	-
30 mg	PD 0200390	-
5 mg	PD 0200390	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Dose-response relationship of PD 200390 on wake after sleep onset (WASO) in subjects with primary insomnia as determined by Polysomnography	weekly

Secondary Outcome Measures

Name	Time	Method
Subjective assessment of sleep with Leeds Sleep Evaluation Questionnaire-LSEQ.	weekly
PSG efficacy assessments including number of awakenings after sleep onset (NAASO), number of arousals, total sleep time (TST), sleep efficiency (SE), total wake time (TWT)	weekly
Subjective assessments of wake after sleep onset (sWASO), latency to sleep onset (LSO), number of awakenings after sleep onset (sNAASO), total sleep time (TST), and sleep quality via questionnaire.	weekly
Latency to persistent sleep (LPS) as determined by Polysomnography	weekly

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Cincinnati, Ohio, United States