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Completed

NCT Number: NCT00569972

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

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

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Key information

Conditions

Insomnia Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Pfizer Investigational Site, Calgary, Alberta, Canada

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PD 0200390

Drug

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

Placebo

Drug

Matched oral placebo for weeks 2-7.

Primary outcomes

  1. 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

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

    Time frame: Weekly

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

    Time frame: Weekly

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

    Time frame: Weekly

  4. 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

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

    Time frame: Weekly

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Dec 10, 2007
Registry last updated
Jul 25, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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