Safety of MK0928 on Insomnia in the Elderly (0928-005)(COMPLETED)

A 12-Month, Randomized, Double-Blind, Placebo-Controlled, Parallel Groups, Multicenter Long-Term Safety Study of MK0928 in the Treatment of Elderly Outpatients With Primary Insomnia

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00095043

Enrollment

320

Registered

2004-11-01

Start date

2004-10-31

Completion date

Unknown

Last updated

2016-11-17

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 of MK0928 on insomnia in the elderly.

Detailed description

The duration of treatment is 1 year.

Interventions

DRUGMK0928, gaboxadol

DRUGComparator: placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

Healthy volunteers

Inclusion criteria

* Diagnosis of Insomnia

Design outcomes

Primary

Measure	Time frame
Safety and tolerability after 12 months of treatment	—

Secondary

Measure	Time frame
Discontinuation symptoms and rebound insomnia using sleep diary and Tyrer Withdrawal Symptom Questionnaire	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026