A Randomized, Double Blind, Parallel Group, Placebo Controlled, Multicenter Outpatient Trial Of PD 0200390 In Adults With Primary Insomnia

Pfizer682 enrolled

Overview

To demonstrate efficacy and characterize the dose response relationship of PD 0200390 on subjective wake after sleep onset in subjects with primary insomnia.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

682

Conditions

Insomnia

Interventions

PD 0200390DRUG

Capsules, 15 mg, 3 capsules each night before bedtime, Duration - Visit 3-7 for 28 days

PD 0200390DRUG

Capsules, 30 mg, 3 capsules each night before bedtime; Duration - Visit 3-7 for 28 days

PD 0200390DRUG

Capsules, 45 mg, 3 capsules each night before bedtime, Duration- Visit 3-7 for 28 days

Eligibility

Sex: ALLMin age: 18 YearsMax age: 64 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 3 month history of primary insomnia; * 18 to 64 years * For the last 3 months-regularly awake unrefreshed and unrestored * Difficulty initiating and maintaining sleep for at least 3 nights/week for the past month (difficulty falling asleep, difficulty staying asleep, early awakening) Exclusion Criteria: * Any history of an Axis 1 psychiatric diagnosis; * History or presence of any breathing related sleep disorder; * History or presence of any medical or neurological condition that could interfere with sleep * Use of alcohol as a sleep aid or more than 2 standard drinks consumed per day or more than 14 consumed per week

Locations (84)

Outcomes

Primary Outcomes

To demonstrate efficacy and characterize the dose response relationship of PD 0200390 on subjective wake after sleep onset in subjects with primary insomnia.

Time frame: Weekly

Secondary Outcomes

To characterize the dose response relationship of PD 0200390 on functional outcome measures in subjects with primary insomnia.

Time frame: Weekly

To characterize the exposure response relationship of safety & efficacy parameters following administration of PD 0200390 in subjects with primary insomnia.

Time frame: Weekly

To investigate the potential for rebound insomnia and withdrawal effects after discontinuation of PD 0200390 in subjects with primary insomnia.

Time frame: Weekly

To characterize the dose response relationship of PD 0200390 on subjective assessments of latency to sleep onset (LSO), number of awakenings after sleep onset (sNAASO) and total sleep time (sTST) in subjects with primary insomnia.

Time frame: Weekly

To investigate the safety and tolerability of PD 0200390 administered once daily before bedtime in subjects with primary insomnia.

Time frame: Weekly

Data from ClinicalTrials.gov

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Pfizer Investigational Site

Birmingham, Alabama, United States

Pfizer Investigational Site

Phoenix, Arizona, United States

Pfizer Investigational Site

Phoenix, Arizona, United States

Pfizer Investigational Site

Scottsdale, Arizona, United States

Pfizer Investigational Site

Tucson, Arizona, United States

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Little Rock, Arkansas, United States

Pfizer Investigational Site

Encino, California, United States

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Garden Grove, California, United States

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Los Alamitos, California, United States

Pfizer Investigational Site

Newport Beach, California, United States

...and 74 more locations