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

December 6, 2007
July 17, 2012
October 2007
January 2009   (final data collection date for primary outcome measure)
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 ]
To demonstrate efficacy and characterize the dose response relationship of PD 0200390 on subjective wake after sleep onset in subjects with primary insomnia.
Complete list of historical versions of study NCT00569972 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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.
  • To characterize the dose response relationship of PD 0200390 on functional outcome measures in subjects with primary insomnia.
  • To investigate the safety and tolerability of PD 0200390 administered once daily before bedtime in subjects with primary insomnia.
  • To investigate the potential for rebound insomnia and withdrawal effects after discontinuation of PD 0200390 in subjects with primary insomnia.
  • To characterize the exposure response relationship of safety & efficacy parameters following administration of PD 0200390 in subjects with primary insomnia.
Not Provided
Not Provided
 
A Randomized, Double Blind, Parallel Group, Placebo Controlled, Multicenter Outpatient Trial Of PD 0200390 In Adults With Primary Insomnia
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Insomnia
  • 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.
  • Experimental: 15 mg PD 0200390
    Intervention: Drug: PD 0200390
  • Experimental: 30 mg PD 0200390
    Intervention: Drug: PD 0200390
  • Experimental: 45 mg PD 0200390
    Intervention: Drug: PD 0200390
  • Experimental: 60 mg PD 0200390
    Intervention: Drug: PD 0200390
  • Experimental: Placebo PD 0200390
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
682
January 2009
January 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 64 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00569972
A4251037
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP