A Double-blind, Parallel Group, Placebo-Controlled Outpatient Trial of PD 00200390 in Adults With Nonrestorative Sleep

NCT00655369 | Completed Phase 2

• 1 other identifier: A4251033
• Study Type: interventional
• Target: 306
• Locations: 2 countries
• Sites: 59

Brief Summary

In a Phase II trial in subjects with nonrestorative sleep, PD 0200390 demonstrated a positive treatment effect relative to placebo on the primary endpoint, the weekly version of the Restorative Sleep Questionnaire (RSQ-W). In this study, the dose-response relationship of varying doses of PD 0200390 using the Restorative Sleep Questionnaire (RSQ-W), will be explored in Nonrestorative Sleep subjects.

Conditions

Nonrestorative Sleep

Outcome Measures

Primary Outcomes (1)

• Total score of how an individual rates the restorative value of his/her sleep in the morning using the weekly version of the Restorative Sleep Questionnaire (RSQ-Weekly)

  Weekly

Secondary Outcomes (9)

• Measure sleep and early morning behavior during treatment using the Leeds Sleep Evaluation Questionnaire

  Weeky

• Total score of the Daily Restorative Sleep Questionnaire

  Daily

• Total score of the Multidimensional Assessment of Fatigue (MAF)

  Weekly

• Total score of the Sheehan Disability Scale to measure functional impairment

  Weekly

• Measure of health status using the Medical Outcomes Study Short Form-36 (SF-36v2-Acute)

  Weekly

Study Arms (6)

15 mg

EXPERIMENTAL

Drug: PD 0200390

25 mg

EXPERIMENTAL

Drug: PD 0200390

35 mg

EXPERIMENTAL

Drug: PD 0200390

5 mg

EXPERIMENTAL

Drug: PD 0200390

50 mg

EXPERIMENTAL

Drug: PD 0200390

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

PD 0200390 DRUG

oral 15 mg daily dose, 3 capsules per dose during a six week treatment period.

15 mg

Placebo DRUG

oral placebo daily dose, 3 capsules per dose during a six week treatment period.

Placebo

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Awake unrestored or unrefreshed, associated with significant distress or impairment in social, occupational, or other important areas of functioning during the daytime, for at least 3 nights for the past 3 months prior to screening
• Self-report wake after sleep onset \<45 mins for past 3 mos; self-report latency to sleep onset \<20 mins for past 3 mos
• PSG (Polysomnography) sleep criteria of wake after sleep onset \< 45 mins; Latency to persistent sleep \<20 mins.

You may not qualify if:

• MAP (Multivariable Apnea Risk index) index \> or = 0.5 at screening
• BMI = or \> 32 kg/m2
• History or presence of breathing related disorders
• PSG findings consistent with and periodic limb movement disorder, narcolepsy or other dyssomnia or parasomnia including apnea-hypopnea index \> 10/hr; or period limb movement with arousal index \> 10/hr.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (59)

Pfizer Investigational Site

Glendale, Arizona, 85306, United States

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Phoenix, Arizona, 85306, United States

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Tucson, Arizona, 85712, United States

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Little Rock, Arkansas, 72205, United States

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Los Angeles, California, 90048, United States

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Pasadena, California, 91106, United States

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San Diego, California, 92103, United States

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San Francisco, California, 94105, United States

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Tustin, California, 92780, United States

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Wheat Ridge, Colorado, 80033, United States

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North Haven, Connecticut, 06473, United States

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Wallingford, Connecticut, 06492, United States

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DeLand, Florida, 32720, United States

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Miami, Florida, 33143, United States

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Naples, Florida, 34110, United States

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Orange City, Florida, 32763, United States

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Orlando, Florida, 32806, United States

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Pembroke Pines, Florida, 33026, United States

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South Miami, Florida, 33143, United States

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Atlanta, Georgia, 30328, United States

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Atlanta, Georgia, 30342, United States

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Gainesville, Georgia, 30501, United States

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Chicago, Illinois, 60634, United States

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Indianapolis, Indiana, 46260, United States

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Overland Park, Kansas, 66212, United States

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Crestview Hills, Kentucky, 41017, United States

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Lexington, Kentucky, 40504, United States

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Lexington, Kentucky, 40513, United States

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Baton Rouge, Louisiana, 70809, United States

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Chevy Chase, Maryland, 20815, United States

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Brighton, Massachusetts, 02135, United States

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North Dartmouth, Massachusetts, 02747, United States

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Chesterfield, Missouri, 63017, United States

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St Louis, Missouri, 63108, United States

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Las Vegas, Nevada, 89104, United States

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Las Vegas, Nevada, 89146, United States

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West Seneca, New York, 14224, United States

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Cary, North Carolina, 27511, United States

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Raleigh, North Carolina, 27607-6520, United States

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Raleigh, North Carolina, 27612, United States

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Salisbury, North Carolina, 28144, United States

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Winston-Salem, North Carolina, 27103, United States

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Cincinnati, Ohio, 45227, United States

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Oklahoma City, Oklahoma, 73112, United States

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Clarks Summit, Pennsylvania, 18411, United States

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Uniontown, Pennsylvania, 15401, United States

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Warwick, Rhode Island, 02886, United States

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West Warwick, Rhode Island, 02893, United States

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Columbia, South Carolina, 29201, United States

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Austin, Texas, 78756, United States

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Dallas, Texas, 75230, United States

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Irving, Texas, 75039, United States

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Kelowna, British Columbia, V1Y 3G8, Canada

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Kelowna, British Columbia, V1Y 4R9, Canada

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Etobicoke, Ontario, M9W 6V1, Canada

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Kitchener, Ontario, N2G 1G1, Canada

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Parry Sound, Ontario, P2A 3A4, Canada

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Toronto, Ontario, M4P 1P2, Canada

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Toronto, Ontario, M6J 3S3, Canada

Location

Related Publications (1)

• Drake CL, Hays RD, Morlock R, Wang F, Shikiar R, Frank L, Downey R, Roth T. Development and evaluation of a measure to assess restorative sleep. J Clin Sleep Med. 2014 Jul 15;10(7):733-41, 741A-741E. doi: 10.5664/jcsm.3860.

  PMID: 25024650 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

(1-aminomethyl-3,4-dimethylcyclopentyl)acetic acid

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2008
• First Posted: April 9, 2008
• Study Start: April 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: July 25, 2012

Record last verified: 2012-07

Locations

CA (7); US (52)