Elderly Primary Insomnia Polysomnographic Study (0928-002)(TERMINATED)

NCT ID: NCT00094666

Last Updated: 2015-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

465 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Study Completion Date

2007-03-31

Brief Summary

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The purpose of the study is to test the safety and effectiveness of an Investigational Drug on insomnia in the elderly.

Detailed Description

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Conditions

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Primary Insomnia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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MK0928, gaboxadol / Duration of Treatment - 6 weeks

Intervention Type DRUG

Comparator: placebo / Duration of Treatment - 6 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Elderly patients with a diagnosis of primary insomnia and in good physical and mental health
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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H. Lundbeck A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Merck Sharp & Dohme Corp

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

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Lankford DA, Corser BC, Zheng YP, Li Z, Snavely DB, Lines CR, Deacon S. Effect of gaboxadol on sleep in adult and elderly patients with primary insomnia: results from two randomized, placebo-controlled, 30-night polysomnography studies. Sleep. 2008 Oct;31(10):1359-70.

Reference Type BACKGROUND
PMID: 18853933 (View on PubMed)

Svetnik V, Snyder ES, Tao P, Roth T, Lines C, Herring WJ. How well can a large number of polysomnography sleep measures predict subjective sleep quality in insomnia patients? Sleep Med. 2020 Mar;67:137-146. doi: 10.1016/j.sleep.2019.08.020. Epub 2019 Sep 11.

Reference Type DERIVED
PMID: 31926466 (View on PubMed)

Other Identifiers

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MK0928-002

Identifier Type: -

Identifier Source: secondary_id

2004_085

Identifier Type: -

Identifier Source: secondary_id

0928-002

Identifier Type: -

Identifier Source: org_study_id

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