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

Primary Insomnia Clinical Trial

Official title:

PD 0200390 Dose-ranging Trial: A Randomized, Double-blind, Placebo-controlled, 5-way Crossover, Multicenter Polysomnography Trial of PD 0200390 in Adults With Primary Insomnia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00551148
• Other study ID #: A4251068
• Status: Completed
• Phase: Phase 2
• First received: October 27, 2007
• Last updated: July 17, 2012
• Start date: October 2007
• Est. completion date: January 2008

Study information

• Verified date: July 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Primary Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Drug:
• PD 0200390
oral 15 mg dose on 2 consecutive nights. This is one of 5 treatment doses administered one week apart for 5 consecutive weeks.
• PD 0200390
oral 30 mg dose on 2 consecutive nights. This is one of 5 treatment doses administered one week apart for 5 consecutive weeks.
• PD 0200390
oral 5 mg dose on 2 consecutive nights. This is one of 5 treatment doses administered one week apart for 5 consecutive weeks.
• PD 0200390
oral 60 mg dose on 2 consecutive nights. This is one of 5 treatment doses administered one week apart for 5 consecutive weeks.

Other:
• Placebo
oral placebo mg dose on 2 consecutive nights. This is one of 5 treatment doses administered one week apart for 5 consecutive weeks.

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Atlanta	Georgia
United States	Pfizer Investigational Site	Atlanta	Georgia
United States	Pfizer Investigational Site	Cary	North Carolina
United States	Pfizer Investigational Site	Cincinnati	Ohio
United States	Pfizer Investigational Site	Crestview Hills	Kentucky
United States	Pfizer Investigational Site	Glendale	Arizona
United States	Pfizer Investigational Site	Miami	Florida
United States	Pfizer Investigational Site	Naples	Florida
United States	Pfizer Investigational Site	New York	New York
United States	Pfizer Investigational Site	Overland Park	Kansas
United States	Pfizer Investigational Site	Phenoix	Arizona
United States	Pfizer Investigational Site	Phoenix	Arizona
United States	Pfizer Investigational Site	Raleigh	North Carolina
United States	Pfizer Investigational Site	San Diego	California
United States	Pfizer Investigational Site	South Miami	Florida
United States	Pfizer Investigational Site	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose-response relationship of PD 200390 on wake after sleep onset (WASO) in subjects with primary insomnia as determined by Polysomnography		weekly	No
Secondary	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	No
Secondary	Subjective assessment of sleep with Leeds Sleep Evaluation Questionnaire-LSEQ.		weekly	No
Secondary	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	No
Secondary	Latency to persistent sleep (LPS) as determined by Polysomnography		weekly	No

External Links

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