MK0928 Study 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 IIb Dose-range Finding 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: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Intervention(s) in this Clinical Trial
- Drug: MK0928, gaboxadol / Duration of Treatment 3 Weeks
- Drug: Placebo / Duration of Treatment 3 Weeks
Outcome Measures for this Clinical Trial
Primary Measures
- Patient-reported total sleep time.
Secondary Measures
- Patient-reported time to sleep onset, number of awakenings, wake time after sleep onset and premature awakening.
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/NCT00266344
Study ID Number: 2005_106
ClinicalTrials.gov Identifier: NCT00266344
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/NCT00266344
