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

A Double-Blind, Randomized, Multicenter, Placebo-Controlled, Parallel-Group Efficacy Study of MK0928 15 mg and 10 mg in the Treatment of Adult Outpatients With Primary Insomnia

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00103818

Enrollment

900

Registered

2005-02-16

Start date

2005-02-28

Completion date

2006-10-31

Last updated

2015-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insomnia

Brief summary

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

Interventions

DRUGgaboxadol

Duration of Treatment: 3 months

DRUGComparator: placebo (unspecified)

Duration of Treatment: 3 months

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 64 Years

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame
Patient-reported amount of sleep and time to fall asleep at night after 3 months	After 3 months

Secondary

Measure	Time frame
Patient-reported awakenings at night	After 3 months
Sleep quality	After 3 months
Functioning after 3 months	After 3 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 1, 2026