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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00569972
First received: December 6, 2007
Last updated: July 17, 2012
Last verified: July 2012
  Purpose

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


Condition Intervention Phase
Insomnia
Drug: PD 0200390
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Further study details as provided by Pfizer:

Primary Outcome 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To characterize the dose response relationship of PD 0200390 on functional outcome measures in subjects with primary insomnia. [ Time Frame: Weekly ] [ Designated as 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 ] [ Designated as 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 ] [ Designated as 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 ] [ Designated as 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 ] [ Designated as safety issue: Yes ]

Enrollment: 682
Study Start Date: October 2007
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 15 mg PD 0200390 Drug: PD 0200390
Capsules, 15 mg, 3 capsules each night before bedtime, Duration - Visit 3-7 for 28 days
Experimental: 30 mg PD 0200390 Drug: PD 0200390
Capsules, 30 mg, 3 capsules each night before bedtime; Duration - Visit 3-7 for 28 days
Experimental: 45 mg PD 0200390 Drug: PD 0200390
Capsules, 45 mg, 3 capsules each night before bedtime, Duration- Visit 3-7 for 28 days
Experimental: 60 mg PD 0200390 Drug: PD 0200390
Capsules, 60 mg, 3 capsules each night before bedtime, Duration - Visit 3-7 for 28 days
Experimental: Placebo PD 0200390 Drug: Placebo
Matched oral placebo for weeks 2-7.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  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: NCT00569972

  Show 84 Study Locations
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: NCT00569972     History of Changes
Other Study ID Numbers: A4251037
Study First Received: December 6, 2007
Last Updated: July 17, 2012
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 26, 2014