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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00551148
First received: October 27, 2007
Last updated: July 17, 2012
Last verified: July 2012
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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: 92
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
Experimental: 15 mg 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.
Experimental: 30 mg 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.
Experimental: 5 mg 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.
Experimental: 60 mg 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 Comparator: Placebo 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00551148     History of Changes
Other Study ID Numbers: A4251068
Study First Received: October 27, 2007
Last Updated: July 17, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Dyssomnias
Mental Disorders
Nervous System Diseases
Sleep Disorders
Sleep Disorders, Intrinsic

ClinicalTrials.gov processed this record on November 25, 2014