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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00095069
Other study ID # 0928-003
Secondary ID MK0928-0032004_0
Status Completed
Phase Phase 3
First received October 29, 2004
Last updated January 13, 2015
Start date October 2004
Est. completion date February 2007

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


Recruitment information / eligibility

Status Completed
Enrollment 600
Est. completion date February 2007
Est. primary completion date February 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 64 Years
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


Intervention

Drug:
MK0928, gaboxadol / Duration of Treatment - 1 year

Comparator: placebo / Duration of Treatment -1 year


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 sleep at night after three months
Secondary Patient-reported awakenings at night
Secondary Sleep quality
Secondary Functioning after 3 months
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