Effects Of GW679769 On Sleep Onset And Maintenance And Next Day Functioning In Subjects With Primary Insomnia

Sponsor

GlaxoSmithKline (Industry)

Overall Status

Completed

CT.gov ID

NCT00280423

Collaborator

(none)

342

Enrollment

Locations

Duration (Months)

4.8

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is designed to find the optimal (best) doses of GW679769 that could be given daily to promote sleep onset and maintain sleep during the night without significant next-day thinking impairment and drowsiness in subjects with primary insomnia.

Condition or Disease	Intervention/Treatment	Phase
Sleep Initiation and Maintenance Disorders Insomnia	Drug: GW679769	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

342 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

A 28 Day, Polysomnographic and Subjective Assessment of GW679769 for the Treatment of Primary Insomnia: A Randomized, Double-blind, Parallel-Group, Placebo-Controlled Trial.

Study Start Date :

Jan 1, 2006

Actual Primary Completion Date :

Feb 1, 2007

Actual Study Completion Date :

Feb 1, 2007

Outcome Measures

Primary Outcome Measures

Comparison of GW679769 and placebo on the time needed to fall asleep at bedtime on Nights 1/2, 13/14 and 27/28 of treatment, as assessed by electroencephalography and other physiological changes during sleep. [28 Days]

Secondary Outcome Measures

Comparison of GW679769 and placebo effects on sleep maintenance and duration on Nights 1/2, 13/14 and 27/28 of treatment, as assessed by electroencephalography and subject diaries, and on next-day memory, alertness and physical coordination. [28 Days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 64 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Difficulty going to sleep and/or staying asleep for at least the past 3 months.
Insomnia must result in significant distress or impairment in functioning at home, socially or at work.
Otherwise good health with no significant or unstable medical disorder including psychiatric, neurological, endocrine, heart, lung or gastrointestinal disorders, drug/alcohol abuse, cognitive impairment, cancer or chronic pain conditions such as arthritis.

Exclusion Criteria:

History of other sleep disorders such as sleep apnea or restless leg syndrome.
Regular sleep habits, including bedtime between 9 PM and midnight.
No nightshift/rotating shift work, frequent napping or planned travel across >2 time zones.
Use of nicotine, caffeine and alcoholic products.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Birmingham	Alabama	United States	35213
2	GSK Investigational Site	Phoenix	Arizona	United States	85050
3	GSK Investigational Site	Tucson	Arizona	United States	85712
4	GSK Investigational Site	Little Rock	Arkansas	United States	72205
5	GSK Investigational Site	Burbank	California	United States	91506
6	GSK Investigational Site	Huntington Beach	California	United States	92648
7	GSK Investigational Site	Irvine	California	United States	92618
8	GSK Investigational Site	Los Angeles	California	United States	90048
9	GSK Investigational Site	National City	California	United States	91950
10	GSK Investigational Site	San Diego	California	United States	92121
11	GSK Investigational Site	San Diego	California	United States	92123
12	GSK Investigational Site	San Diego	California	United States	92161
13	GSK Investigational Site	San Francisco	California	United States	94105
14	GSK Investigational Site	Santa Rosa	California	United States	95405
15	GSK Investigational Site	Norwalk	Connecticut	United States	06850
16	GSK Investigational Site	Deland	Florida	United States	32720
17	GSK Investigational Site	Delray Beach	Florida	United States	33484
18	GSK Investigational Site	Hallandale Beach	Florida	United States	33009
19	GSK Investigational Site	Largo	Florida	United States	33773
20	GSK Investigational Site	Miami	Florida	United States	33143
21	GSK Investigational Site	Miami	Florida	United States	33173
22	GSK Investigational Site	Miami	Florida	United States	33176
23	GSK Investigational Site	Pembroke Pines	Florida	United States	33026
24	GSK Investigational Site	Atlanta	Georgia	United States	30328
25	GSK Investigational Site	Atlanta	Georgia	United States	30342
26	GSK Investigational Site	Gainesville	Georgia	United States	30501
27	GSK Investigational Site	Hinesville	Georgia	United States	31313
28	GSK Investigational Site	Macon	Georgia	United States	31201
29	GSK Investigational Site	Stockbridge	Georgia	United States	30281
30	GSK Investigational Site	Chicago	Illinois	United States	60611
31	GSK Investigational Site	Chicago	Illinois	United States	60612
32	GSK Investigational Site	Chicago	Illinois	United States	60634
33	GSK Investigational Site	Overland Park	Kansas	United States	66211
34	GSK Investigational Site	Crestview Hills	Kentucky	United States	41017
35	GSK Investigational Site	Rockville	Maryland	United States	20852
36	GSK Investigational Site	Newton	Massachusetts	United States	02459
37	GSK Investigational Site	Troy	Michigan	United States	48085
38	GSK Investigational Site	Hattiesburg	Mississippi	United States	39404
39	GSK Investigational Site	Las Vegas	Nevada	United States	89104
40	GSK Investigational Site	Clementon	New Jersey	United States	08021
41	GSK Investigational Site	West Seneca	New York	United States	14224
42	GSK Investigational Site	Durham	North Carolina	United States	27705
43	GSK Investigational Site	Salisbury	North Carolina	United States	28144
44	GSK Investigational Site	Winston-Salem	North Carolina	United States	27157
45	GSK Investigational Site	Beachwood	Ohio	United States	44122
46	GSK Investigational Site	Cincinnati	Ohio	United States	45227
47	GSK Investigational Site	Cincinnati	Ohio	United States	45246
48	GSK Investigational Site	Cleveland	Ohio	United States	44130
49	GSK Investigational Site	Gallipolis	Ohio	United States	45631
50	GSK Investigational Site	Oklahoma City	Oklahoma	United States	73112
51	GSK Investigational Site	Gresham	Oregon	United States	97020
52	GSK Investigational Site	Clarks Summit	Pennsylvania	United States	18411
53	GSK Investigational Site	Duncansville	Pennsylvania	United States	16635
54	GSK Investigational Site	Warwick	Rhode Island	United States	02886
55	GSK Investigational Site	Columbia	South Carolina	United States	29201
56	GSK Investigational Site	Austin	Texas	United States	78756
57	GSK Investigational Site	Bellaire	Texas	United States	77401
58	GSK Investigational Site	Dallas	Texas	United States	75251
59	GSK Investigational Site	Houston	Texas	United States	77030
60	GSK Investigational Site	Plano	Texas	United States	75093
61	GSK Investigational Site	Salt Lake City	Utah	United States	84107
62	GSK Investigational Site	Calgary	Alberta	Canada	T2X 2A8
63	GSK Investigational Site	Mississauga	Ontario	Canada	L5B4M4
64	GSK Investigational Site	Niagara Falls	Ontario	Canada	L2G 1J4
65	GSK Investigational Site	Parrry Sound	Ontario	Canada	P2A 1T3
66	GSK Investigational Site	Toronto	Ontario	Canada	M4P 1P2
67	GSK Investigational Site	Toronto	Ontario	Canada	M5G 1E2
68	GSK Investigational Site	Toronto	Ontario	Canada	M5T3A9
69	GSK Investigational Site	Toronto	Ontario	Canada	M6J 3S3
70	GSK Investigational Site	Montreal	Quebec	Canada	H4J 1C5
71	GSK Investigational Site	Sainte-Foy	Quebec	Canada	G1V 4G5