Sleep Laboratory Study of MK0928 in Adult Patients With Primary Insomnia (0928-041)(TERMINATED)

Primary Insomnia Clinical Trial

Official title:

MK0928 Phase II Sleep Laboratory Study - Primary Insomnia

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00266357
• Other study ID #: 0928-041
• Secondary ID: 2005_107
• Status: Terminated
• Phase: Phase 2
• First received: December 14, 2005
• Last updated: January 13, 2015
• Start date: November 2005

Study information

• Verified date: January 2015
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

A study to evaluate the efficacy, safety and tolerability of MK-0928 in Primary Insomnia.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 50
• Est. primary completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 64 Years

Eligibility

Inclusion Criteria:

• Patients with a diagnosis of primary insomnia

Exclusion Criteria:

• Patients with an active psychiatric disorder other than primary insomnia

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Primary Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Drug:
• MK0928, gaboxadol / Duration of Treatment: 6 days for treatment periods (2 days/dose)

• Placebo / Duration of Treatment: 2 days for screening period

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	Mean of total sleep time over 2 nights.
Secondary	Mean of other PSG sleep parameters over 2 nights, mean of subjective sleep parameters, and exploratory residual effect.