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

Official 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”

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

Intervention(s) in this Clinical Trial

• Drug: PD 0200390
  • Capsules, 15 mg, 3 capsules each night before bedtime, Duration - Visit 3-7 for 28 days
• Drug: PD 0200390
  • Capsules, 30 mg, 3 capsules each night before bedtime; Duration - Visit 3-7 for 28 days
• Drug: PD 0200390
  • Capsules, 45 mg, 3 capsules each night before bedtime, Duration- Visit 3-7 for 28 days
• Drug: PD 0200390
  • Capsules, 60 mg, 3 capsules each night before bedtime, Duration - Visit 3-7 for 28 days
• Drug: Placebo
  • Matched oral placebo for weeks 2-7.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 15 mg PD 0200390
• Experimental: 30 mg PD 0200390
• Experimental: 45 mg PD 0200390
• Experimental: 60 mg PD 0200390
• Experimental: Placebo PD 0200390

Primary Measures

• 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
    Safety Issue?: No

Secondary Measures

• To characterize the dose response relationship of PD 0200390 on functional outcome measures in subjects with primary insomnia.
  • Time Frame: Weekly
    Safety Issue?: No
• To characterize the exposure response relationship of safety & efficacy parameters following administration of PD 0200390 in subjects with primary insomnia.
  • Time Frame: Weekly
    Safety Issue?: Yes
• To investigate the potential for rebound insomnia and withdrawal effects after discontinuation of PD 0200390 in subjects with primary insomnia.
  • Time Frame: Weekly
    Safety Issue?: No
• 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
    Safety Issue?: No
• To investigate the safety and tolerability of PD 0200390 administered once daily before bedtime in subjects with primary insomnia.
  • Time Frame: Weekly
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 64 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Investigator: Pfizer Industry

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00569972

Study ID Number: A4251037

ClinicalTrials.gov Identifier: NCT00569972

Health Authority: United States: Food and Drug Administration

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