Efficacy and Safety of MK0928 for Insomnia in Adults (0928-003)(COMPLETED)

NCT ID: NCT00095069

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

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Study Completion Date

2007-02-28

Brief Summary

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The purpose of this trial is to study the safety and effectiveness of MK0928 for adults with insomnia.

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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MK0928, gaboxadol / Duration of Treatment - 1 year

Intervention Type DRUG

Comparator: placebo / Duration of Treatment -1 year

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of insomnia
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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MK0928-003

Identifier Type: -

Identifier Source: secondary_id

2004_086

Identifier Type: -

Identifier Source: secondary_id

0928-003

Identifier Type: -

Identifier Source: org_study_id

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