Status:
COMPLETED
To Evaluate The Effects Of SB-649868 (10, 30 Mg And 60 Mg) On Subjects With Primary Insomnia
Lead Sponsor:
GlaxoSmithKline
Conditions:
Sleep Initiation and Maintenance Disorders
Eligibility:
MALE
18-64 years
Phase:
PHASE2
Brief Summary
This study to evaluate the effects of SB-649868 (10, 30 mg and 60 mg) on sleep continuity, PSG sleep recordings, subjective sleep assessment, and daytime cognitive function in subjects with primary in...
Eligibility Criteria
Inclusion
- Male
- 18-64 years of age (inclusive),
- Diagnosis of primary insomnia who have had symptoms for at least three months.
Exclusion
- Any clinically significant unstable medical or surgical condition (treated or untreated).
- Any history of a clinically significant abnormality of the neurological system (including cognitive disorders or significant head injury) or any history of seizure (including febrile seizure).
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2007
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00426816
Start Date
December 1 2006
End Date
May 1 2007
Last Update
August 13 2012
Active Locations (10)
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1
GSK Investigational Site
Mannheim, Baden-Wurttemberg, Germany, 68159
2
GSK Investigational Site
Cottbus, Brandenburg, Germany, 03050
3
GSK Investigational Site
Hamburg, Hamburg, Germany, 20249
4
GSK Investigational Site
Schwerin, Mecklenburg-Vorpommern, Germany, 19055