Back to resultsSafety of MK0928 on Insomnia in the Elderly (0928-005)(COMPLETED)
Primary Purpose
Insomnia
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
MK0928, gaboxadol
Comparator: placebo
Sponsored by
About this trial
This is an interventional treatment trial for Insomnia
Eligibility Criteria
Inclusion Criteria: Diagnosis of Insomnia
Sites / Locations
Outcomes
Primary Outcome Measures
Safety and tolerability after 12 months of treatment
Secondary Outcome Measures
Discontinuation symptoms and rebound insomnia using sleep diary and Tyrer Withdrawal Symptom Questionnaire
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00095043
Brief Title
Safety of MK0928 on Insomnia in the Elderly (0928-005)(COMPLETED)
Official Title
A 12-Month, Randomized, Double-Blind, Placebo-Controlled, Parallel Groups, Multicenter Long-Term Safety Study of MK0928 in the Treatment of Elderly Outpatients With Primary Insomnia
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lundbeck A/S
4. Oversight
5. Study Description
Brief Summary
The purpose of this trial is to study the safety of MK0928 on insomnia in the elderly.
Detailed Description
The duration of treatment is 1 year.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
320 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
MK0928, gaboxadol
Intervention Type
Drug
Intervention Name(s)
Comparator: placebo
Primary Outcome Measure Information:
Title
Safety and tolerability after 12 months of treatment
Secondary Outcome Measure Information:
Title
Discontinuation symptoms and rebound insomnia using sleep diary and Tyrer Withdrawal Symptom Questionnaire
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of Insomnia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Safety of MK0928 on Insomnia in the Elderly (0928-005)(COMPLETED)
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