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

Insomnia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00103818
• Other study ID #: 0928-014
• Secondary ID: MK0928-0142005_0
• Status: Completed
• Phase: Phase 3
• First received: February 15, 2005
• Last updated: January 13, 2015
• Start date: February 2005
• Est. completion date: October 2006

Study information

• Verified date: January 2015
• 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 study is to evaluate the safety and effectiveness of MK0928 for insomnia (a sleep disorder).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 900
• Est. completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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)

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

Intervention

Drug:
• gaboxadol
Duration of Treatment: 3 months
• Comparator: placebo (unspecified)
Duration of Treatment: 3 months

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	Patient-reported amount of sleep and time to fall asleep at night after 3 months		After 3 months	No
Secondary	Patient-reported awakenings at night		After 3 months	No
Secondary	Sleep quality		After 3 months	No
Secondary	Functioning after 3 months		After 3 months	No