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An Investigational Study of MK0928 in Adult Outpatients With Insomnia (0928-014)(COMPLETED)

NCT ID: NCT00103818

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

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

900 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-02-28

Study Completion Date

2006-10-31

Brief Summary

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The purpose of this study is to evaluate the safety and effectiveness of MK0928 for insomnia (a sleep disorder).

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Detailed Description

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Conditions

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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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gaboxadol

Duration of Treatment: 3 months

Intervention Type DRUG

Comparator: placebo (unspecified)

Duration of Treatment: 3 months

Intervention Type DRUG

Other Intervention Names

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MK0928

Eligibility Criteria

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Inclusion Criteria

* Adult outpatients who are between the ages of 18 and 64

Exclusion Criteria

* Adults who do not have a diagnosis of insomnia (a sleep disorder)
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 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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Roth T, Lines C, Vandormael K, Ceesay P, Anderson D, Snavely D. Effect of gaboxadol on patient-reported measures of sleep and waking function in patients with Primary Insomnia: results from two randomized, controlled, 3-month studies. J Clin Sleep Med. 2010 Feb 15;6(1):30-9.

Reference Type DERIVED
PMID: 20191935 (View on PubMed)

Other Identifiers

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MK0928-014

Identifier Type: -

Identifier Source: secondary_id

2005_002

Identifier Type: -

Identifier Source: secondary_id

0928-014

Identifier Type: -

Identifier Source: org_study_id

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