Sleep Laboratory Study of MK0928 in Adult Patients With Primary Insomnia
A study to evaluate the efficacy, safety and tolerability of MK-0928 in Primary Insomnia...
Brief Summary
Official Title: “MK0928 Phase II Sleep Laboratory Study - Primary Insomnia”
A study to evaluate the efficacy, safety and tolerability of MK-0928 in Primary Insomnia.
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Intervention(s) in this Clinical Trial
- Drug: MK0928, gaboxadol / Duration of Treatment: 6 days for treatment periods (2 days/dose)
- Drug: Placebo / Duration of Treatment: 2 days for screening period
Outcome Measures for this Clinical Trial
Primary Measures
- Mean of total sleep time over 2 nights.
Secondary Measures
- Mean of other PSG sleep parameters over 2 nights, mean of subjective sleep parameters, and exploratory residual effect.
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Patients with a diagnosis of primary insomnia
Exclusion Criteria:
- Patients with an active psychiatric disorder other than primary insomnia
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 20 Years
Maximum Age for this Clinical Trial: 64 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Merck Industry
Overall Clinical Trial Officials and Contacts
Medical Monitor Study Director Merck
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00266357
Study ID Number: 2005_107
ClinicalTrials.gov Identifier: NCT00266357
Health Authority: Japan: Ministry of Health, Labor and Welfare
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00266357
