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

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

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

Study Overview

• Status: Completed
• Conditions: Primary Insomnia
• Intervention / Treatment: Drug: PD 0200390; Drug: PD 0200390; Drug: PD 0200390; Drug: PD 0200390; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 92
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • 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
      • Pfizer Investigational Site
  • California
    • San Diego, California, United States, 92103
      • Pfizer Investigational Site
  • Florida
    • Miami, Florida, United States, 33143
      • Pfizer Investigational Site
    • Naples, Florida, United States, 34110
      • Pfizer Investigational Site
    • South Miami, Florida, United States, 33143
      • Pfizer Investigational Site
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Pfizer Investigational Site
    • Atlanta, Georgia, United States, 30328
      • Pfizer Investigational Site
  • Kansas
    • Overland Park, Kansas, United States, 66212
      • Pfizer Investigational Site
  • Kentucky
    • Crestview Hills, Kentucky, United States, 41017
      • Pfizer Investigational Site
  • New York
    • New York, New York, United States, 10019
      • Pfizer Investigational Site
  • North Carolina
    • Cary, North Carolina, United States, 27511
      • Pfizer Investigational Site
    • Raleigh, North Carolina, United States, 27612
      • Pfizer Investigational Site
  • Ohio
    • Cincinnati, Ohio, United States, 45227
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: QUADRUPLE

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.
EXPERIMENTAL: 60 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.; 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.; 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.; 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.
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.; 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.; 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.; 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.
EXPERIMENTAL: 30 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.; 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.; 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.; 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.
EXPERIMENTAL: 5 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.; 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.; 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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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
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
Latency to persistent sleep (LPS) as determined by Polysomnography	weekly

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: October 1, 2007
• Primary Completion (ACTUAL): January 1, 2008
• Study Completion (ACTUAL): January 1, 2008

Study Registration Dates

• First Submitted: October 27, 2007
• First Submitted That Met QC Criteria: October 27, 2007
• First Posted (ESTIMATE): October 30, 2007

Study Record Updates

• Last Update Posted (ESTIMATE): July 25, 2012
• Last Update Submitted That Met QC Criteria: July 17, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: A4251068