Adult Primary Insomnia Polysomnographic Study (0928-004)(COMPLETED)

Primary Insomnia Clinical Trial

Official title:

A Double-Blind, Randomized, Placebo-Controlled, Multicenter, 30-Night Polysomnographic Study of MK0928 in Adult Patients With Primary Insomnia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00094627
• Other study ID #: 0928-004
• Secondary ID: MK0928-0042004_0
• Status: Completed
• Phase: Phase 3
• First received: October 21, 2004
• Last updated: January 13, 2015
• Start date: November 2004
• Est. completion date: April 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 the study is to test the safety and effectiveness of the Investigational Drug on insomnia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 465
• Est. completion date: April 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

Inclusion Criteria:

• Adult patients with a diagnosis of primary insomnia and in good physical and mental health

Exclusion Criteria:

• Adult patients with other medical , neurological and sleep disorders

Study Design

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

Related Conditions & MeSH terms

• Primary Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Drug:
• gaboxadol
Duration of Treatment - 6 weeks
• Comparator: placebo (unspecified)
Duration of Treatment - 6 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

References & Publications (1)

Lankford DA, Corser BC, Zheng YP, Li Z, Snavely DB, Lines CR, Deacon S. Effect of gaboxadol on sleep in adult and elderly patients with primary insomnia: results from two randomized, placebo-controlled, 30-night polysomnography studies. Sleep. 2008 Oct;31(10):1359-70. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount of time spent awake and time to fall asleep at night after 2 days		After 2 days	No
Secondary	Amount of time spent awake and time to fall asleep at night after 30 days		After 30 days	No
Secondary	Amount of deep sleep after 2 days		After 2 days	No