Back to resultsA Prospective Active-Reference Study of Gaboxadol in Primary Insomnia
Primary Purpose
Primary Insomnia
Status
Completed
Phase
Phase 3
Locations
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: diagnosis of Primary insomnia
Sites / Locations
Outcomes
Primary Outcome Measures
Efficacy
Safety
Tolerability
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00209937
Brief Title
A Prospective Active-Reference Study of Gaboxadol in Primary Insomnia
Official Title
A Prospective Randomised Double-Blind Parallel-Group Placebo-Controlled Active-Reference Study of Gaboxadol in Primary Insomnia
Study Type
Interventional
2. Study Status
Record Verification Date
March 2007
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2004 (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 the hypnotic efficacy and safety of different dose levels of gaboxadol with placebo in non-elderly patients with primary insomnia over two weeks of treatment
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
675 (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
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
12. IPD Sharing Statement
Learn more about this trial
A Prospective Active-Reference Study of Gaboxadol in Primary Insomnia
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