A Dose-Ranging, Multicenter Polysomnography Trial of PD 0200390 in Adults With Primary Insomnia - Full Text View

Purpose

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

Condition	Intervention	Phase
Primary Insomnia	Drug: PD 0200390 Other: Placebo	Phase II

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Crossover Assignment, Safety/Efficacy Study

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

Further study details as provided by Pfizer:

Primary Outcome Measures:

Dose-response relationship of PD 200390 on wake after sleep onset (WASO) in subjects with primary insomnia as determined by Polysomnography [ Time Frame: weekly ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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. [ Time Frame: weekly ] [ Designated as safety issue: No ]
Subjective assessment of sleep with Leeds Sleep Evaluation Questionnaire-LSEQ. [ Time Frame: weekly ] [ Designated as safety issue: No ]
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) [ Time Frame: weekly ] [ Designated as safety issue: No ]
Latency to persistent sleep (LPS) as determined by Polysomnography [ Time Frame: weekly ] [ Designated as safety issue: No ]

Enrollment:	83
Study Start Date:	October 2007
Study Completion Date:	January 2008
Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
15 mg: Experimental	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.
30 mg: Experimental	Drug: 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.
5 mg: Experimental	Drug: 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.
60 mg: Experimental	Drug: 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.
Placebo: Placebo Comparator	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.

Eligibility

Ages Eligible for Study:	18 Years to 64 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00551148

Locations


United States, Arizona
	Pfizer Investigational Site
	Glendale, Arizona, United States, 85306
	Pfizer Investigational Site
	Phenoix, Arizona, United States, 85006
	Pfizer Investigational Site
	Phoenix, Arizona, United States, 85006
	Pfizer Investigational Site
	Tucson, Arizona, United States, 85712

United States, California
	Pfizer Investigational Site
	San Diego, California, United States, 92103

United States, Florida
	Pfizer Investigational Site
	Naples, Florida, United States, 34110
	Pfizer Investigational Site
	Miami, Florida, United States, 33143
	Pfizer Investigational Site
	South Miami, Florida, United States, 33143

United States, Georgia
	Pfizer Investigational Site
	Atlanta, Georgia, United States, 30342
	Pfizer Investigational Site
	Atlanta, Georgia, United States, 30328

United States, Kansas
	Pfizer Investigational Site
	Overland Park, Kansas, United States, 66212

United States, Kentucky
	Pfizer Investigational Site
	Crestview Hills, Kentucky, United States, 41017

United States, New York
	Pfizer Investigational Site
	New York, New York, United States, 10019

United States, North Carolina
	Pfizer Investigational Site
	Cary, North Carolina, United States, 27511
	Pfizer Investigational Site
	Raleigh, North Carolina, United States, 27612

United States, Ohio
	Pfizer Investigational Site
	Cincinnati, Ohio, United States, 45227

Sponsors and Collaborators

Pfizer

Investigators


Study Director:	Pfizer CT.gov Call Center	Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A4251068
First Received:	October 27, 2007
Last Updated:	July 17, 2008
ClinicalTrials.gov Identifier:	NCT00551148
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Sleep Initiation and Maintenance Disorders

Mental Disorders

Dyssomnias

Sleep Disorders

Sleep Disorders, Intrinsic

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on October 17, 2008

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00551148