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

Insomnia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00095043
• Other study ID #: 0928-005
• Secondary ID: MK0928-0052004_0
• Status: Completed
• Phase: Phase 3
• First received: October 29, 2004
• Last updated: November 16, 2016
• Start date: October 2004

Study information

• Verified date: November 2016
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this trial is to study the safety of MK0928 on insomnia in the elderly.

Description:

The duration of treatment is 1 year.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 320
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of Insomnia

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Drug:
• MK0928, gaboxadol

• Comparator: placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability after 12 months of treatment
Secondary	Discontinuation symptoms and rebound insomnia using sleep diary and Tyrer Withdrawal Symptom Questionnaire