MK0928 Study in Adult Patients With Primary Insomnia (0928-040)(COMPLETED)
January 13, 2015 updated by: H. Lundbeck A/S
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
520
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 64 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients with a diagnosis of primary insomnia
Exclusion Criteria:
- Patients with an active psychiatric disorder other than primary insomnia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Patient-reported total sleep time.
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Secondary Outcome Measures
Outcome Measure |
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Patient-reported time to sleep onset, number of awakenings, wake time after sleep onset and premature awakening.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2005
Study Completion (Actual)
October 1, 2006
Study Registration Dates
First Submitted
December 14, 2005
First Submitted That Met QC Criteria
December 14, 2005
First Posted (Estimate)
December 16, 2005
Study Record Updates
Last Update Posted (Estimate)
January 14, 2015
Last Update Submitted That Met QC Criteria
January 13, 2015
Last Verified
January 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Nervous System Diseases
- Sleep Disorders, Intrinsic
- Dyssomnias
- Sleep Wake Disorders
- Sleep Initiation and Maintenance Disorders
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- GABA Agents
- Anticonvulsants
- GABA Agonists
- Gaboxadol
Other Study ID Numbers
- 0928-040
- MK0928-040
- 2005_106
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.