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

A Double-Blind, Randomized, Multicenter, Placebo-Controlled, Parallel-Groups Efficacy and Safety Extension Study of MK0928 in the Treatment of Adult Outpatients With Primary Insomnia

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00095069

Enrollment

600

Registered

2004-11-01

Start date

2004-10-31

Completion date

2007-02-28

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

Interventions

DRUGMK0928, gaboxadol / Duration of Treatment - 1 year

DRUGComparator: placebo / Duration of Treatment -1 year

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

* Diagnosis of insomnia

Design outcomes

Primary

Measure	Time frame
Patient-reported amount of sleep and time to fall sleep at night after three months	—

Secondary

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

Outcome results

None listed

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