Back to resultsA Study of Gaboxadol in Primary Insomnia
Primary Purpose
Primary Insomnia
Status
Completed
Phase
Phase 3
Locations
Sweden
Study Type
Interventional
Intervention
Gaboxadol
Sponsored by
About this trial
This is an interventional treatment trial for Primary Insomnia focused on measuring Primary insomnia
Eligibility Criteria
Inclusion Criteria: patients with a diagnosis of primary insomnia
Sites / Locations
- Non-US study, principal location:
Outcomes
Primary Outcome Measures
Efficacy
Safety
Tolerability
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00209924
Brief Title
A Study of Gaboxadol in Primary Insomnia
Official Title
A Prospective Randomised Double-Blind Parallel-Group Placebo-Controlled Study of Gaboxadol in Primary Insomnia
Study Type
Interventional
2. Study Status
Record Verification Date
March 2007
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
H. Lundbeck A/S
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To evaluate the efficacy safety and tolerability of gaboxadol in primary insomnia.
Detailed Description
To compare hypnotic efficacy of gaboxadol with placebo in elderly outpatients with primary insomnia
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Insomnia
Keywords
Primary insomnia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
505 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Gaboxadol
Primary Outcome Measure Information:
Title
Efficacy
Title
Safety
Title
Tolerability
10. Eligibility
Sex
All
Minimum Age & Unit of Time
66 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients with a diagnosis of primary insomnia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Please contact: Annelies van der Hammen Legters
Organizational Affiliation
H. Lundbeck A/S
Official's Role
Study Director
Facility Information:
Facility Name
Non-US study, principal location:
City
Göteborg
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
A Study of Gaboxadol in Primary Insomnia
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