Last updated: 11/04/2018 10:08:41
Disturbed Sleep Model Study.
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A Double-blind, double-dummy, randomised, placebo-controlled,four-way crossover study to investigate the effect of single oral doses of SB-649868 and of Zolpidem in a model of noise induced situational insomnia in healthy male volunteers.
Trial description: Subjects will be screened within 28 days. Each treatment session will consist of 2 PSG nights, study drug administration and noise model is conducted on second night.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Total Sleep Time measured overnight across four treatment sessions (4 weeks)
Timeframe: 4 weeks
Secondary outcomes:
The effects on daytime cognitive function following dosing across four treatment sessions (4 weeks)
Timeframe: 4 weeks
Interventions:
Drug: SB-649868
Drug: Zolpidem
Drug: Placebo
Enrollment:
52
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Sleep Initiation and Maintenance Disorders
Product
SB649868
Collaborators
Not applicable
Study date(s)
January 2007 to July 2007
Type
Interventional
Phase
1
Participation criteria
Sex
Male
Age
18 - 55 years
Accepts healthy volunteers
Yes
- Body weight =50 kg and BMI within the range 18.5-29.9 kg/m2 inclusive
- Healthy as judged by responsible physician.
- A positive result for the pre-study urine drug/ alcohol breath screen.
- Abuse of alcohol.
Inclusion and exclusion criteria
Inclusion criteria:
- Body weight =50 kg and BMI within the range 18.5-29.9 kg/m2 inclusive
- Healthy as judged by responsible physician.
- No clinically significant abnormality identified on the medical or laboratory evaluation and 12-lead ECG;
- The subject shows a normal sleep pattern on the basis of the evaluation of both PSG screening nights. Normal sleep will be defined as follows: LPS (Latency to persistence Sleep) <30min., SE (Sleep Efficiency) >85%, apnea/ hypopnea index < 10, periodic leg movements (PLM) with arousal index < 10. The apnea/hypopnea index is defined as "the number of apneas and hyponeas divided by the total sleep time (TST) expressed in hours". PLMI is defined as "the number of periodic leg movements associated with arousals or awakening divided by the total sleep time (TST) expressed in hour".
Exclusion criteria:
- A positive result for the pre-study urine drug/ alcohol breath screen.
- Abuse of alcohol.
- Subject complains of sleep disturbances and /or is receiving treatment for sleep disorders.
Trial location(s)
Location
GSK Investigational Site
Guildford, Surrey, United Kingdom, GU2 7XP
Status
Will Be Recruiting
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2007-03-07
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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Additional information
Results for study OXS104094 can be found on the GSK Clinical Study Register.
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