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An Evaluation of Potential Next-day Residual Effects of Eszopiclone in Healthy Volunteers.
This study has been completed.
Study NCT00699608   Information provided by GlaxoSmithKline

First Received on June 17, 2008.   Last Updated on March 31, 2011   History of Changes
Results First Received: October 6, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Healthy Subjects
Sleep Initiation and Maintenance Disorders
Intervention: Drug: GSK1755165; placebo; zopiclone

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Eszopiclone First, Zopiclone Second, Placebo Third 3 mg eszopiclone during first intervention period, 7.5 mg zopiclone during second intervention period (after 4-14 day washout period), placebo during third intervention period (after 4-14 day washout period)
Eszopiclone First, Placebo Second, Zopiclone Third 3 mg eszopiclone during first intervention period, placebo during second intervention period (after 4-14 day washout period), 7.5 mg zopiclone during third intervention period (after 4-14 day washout period)
Zopiclone First, Eszopiclone Second, Placebo Third 7.5 mg zopiclone during first intervention period, 3 mg eszopiclone during second intervention period (after 4-14 day washout period), placebo during third intervention period (after 4-14 day washout period)
Zopiclone First, Placebo Second, Eszopiclone Third 7.5 mg zopiclone during first intervention period, placebo during second intervention period (after 4-14 day washout period), 3 mg eszopiclone during third intervention period (after 4-14 day washout period)
Placebo First, Eszopiclone Second, Zopiclone Third Placebo during first intervention period, 3 mg eszopiclone during second intervention period (after 4-14 day washout period), 7.5 mg zopiclone during third intervention period (after 4-14 day washout period)
Placebo First, Zopiclone Second, Eszopiclone Third Placebo during first intervention period, 7.5 mg zopiclone during second intervention period (after 4-14 day washout period), 3 mg eszopiclone during third intervention period (after 4-14 day washout period)

Participant Flow for 5 periods

Period 1:   First Intervention
    Eszopiclone First, Zopiclone Second, Placebo Third     Eszopiclone First, Placebo Second, Zopiclone Third     Zopiclone First, Eszopiclone Second, Placebo Third     Zopiclone First, Placebo Second, Eszopiclone Third     Placebo First, Eszopiclone Second, Zopiclone Third     Placebo First, Zopiclone Second, Eszopiclone Third  
STARTED     16     15     15     15     15     15  
COMPLETED     16     15     14     15     14     15  
NOT COMPLETED     0     0     1     0     1     0  
Withdrawal by Subject                 0                 0                 1                 0                 0                 0  
Protocol Violation                 0                 0                 0                 0                 1                 0  

Period 2:   First 4-14 Day Washout Period
    Eszopiclone First, Zopiclone Second, Placebo Third     Eszopiclone First, Placebo Second, Zopiclone Third     Zopiclone First, Eszopiclone Second, Placebo Third     Zopiclone First, Placebo Second, Eszopiclone Third     Placebo First, Eszopiclone Second, Zopiclone Third     Placebo First, Zopiclone Second, Eszopiclone Third  
STARTED     16     15     14     15     14     15  
COMPLETED     16     15     14     15     14     15  
NOT COMPLETED     0     0     0     0     0     0  

Period 3:   Second Intervention
    Eszopiclone First, Zopiclone Second, Placebo Third     Eszopiclone First, Placebo Second, Zopiclone Third     Zopiclone First, Eszopiclone Second, Placebo Third     Zopiclone First, Placebo Second, Eszopiclone Third     Placebo First, Eszopiclone Second, Zopiclone Third     Placebo First, Zopiclone Second, Eszopiclone Third  
STARTED     16     15     14     15     14     15  
COMPLETED     16     15     13     14     14     15  
NOT COMPLETED     0     0     1     1     0     0  
Adverse Event                 0                 0                 1                 0                 0                 0  
Withdrawal by Subject                 0                 0                 0                 1                 0                 0  

Period 4:   Second 4-14 Day Washout Period
    Eszopiclone First, Zopiclone Second, Placebo Third     Eszopiclone First, Placebo Second, Zopiclone Third     Zopiclone First, Eszopiclone Second, Placebo Third     Zopiclone First, Placebo Second, Eszopiclone Third     Placebo First, Eszopiclone Second, Zopiclone Third     Placebo First, Zopiclone Second, Eszopiclone Third  
STARTED     16     15     13     14     14     15  
COMPLETED     16     15     13     14     14     15  
NOT COMPLETED     0     0     0     0     0     0  

Period 5:   Third Intervention
    Eszopiclone First, Zopiclone Second, Placebo Third     Eszopiclone First, Placebo Second, Zopiclone Third     Zopiclone First, Eszopiclone Second, Placebo Third     Zopiclone First, Placebo Second, Eszopiclone Third     Placebo First, Eszopiclone Second, Zopiclone Third     Placebo First, Zopiclone Second, Eszopiclone Third  
STARTED     16     15     13     14     14     15  
COMPLETED     16     15     13     14     14     15  
NOT COMPLETED     0     0     0     0     0     0  



  Baseline Characteristics
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Reporting Groups
  Description
Entire Study Population No text entered.

Baseline Measures
    Entire Study Population  
Number of Participants  
[units: participants]
  91  
Age  
[units: years]
Mean ± Standard Deviation
  29.8  ± 3.87  
Gender  
[units: participants]
 
Female     46  
Male     45  
Race/Ethnicity, Customized  
[units: participants]
 
White     63  
African American/African Heritage     14  
Asian-Central/South Asian Heritage     6  
Asian-South East Asian Heritage     5  
Asian-East Asian Heritage     3  



  Outcome Measures
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1.  Primary:   Mean Tracking Error Assessed During the Continuous Tracking Test (CTT)   [ Time Frame: 7.5, 8, 8.5, 9, and 9.5 hours post-dose (double-blind) ]

2.  Secondary:   Mean Tracking Error (MTE) Assessed During the CTT   [ Time Frame: 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind) ]

3.  Secondary:   CTT Mean Reaction Time   [ Time Frame: 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind) ]

4.  Secondary:   Critical Flicker Fusion Test–Ascending Threshold   [ Time Frame: 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind) ]

5.  Secondary:   Critical Flicker Fusion Test –Descending Threshold   [ Time Frame: 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind) ]

6.  Secondary:   Critical Flicker Fusion Test–Overall Threshold   [ Time Frame: 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind) ]

7.  Secondary:   Total Number of Attempted Symbol Substitutions, as Assessed by the Digit Symbol Substitution Test   [ Time Frame: 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind) ]

8.  Secondary:   Total Number of Correct Symbol Substitutions, as Assessed by the Digital Symbol Substitution Test   [ Time Frame: 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind) ]

9.  Secondary:   1-Back Percentage of Correct Responses   [ Time Frame: 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind) ]

10.  Secondary:   3-Back Percentage of Correct Responses   [ Time Frame: 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind) ]

11.  Secondary:   1-Back Reaction Time   [ Time Frame: 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind) ]

12.  Secondary:   3-Back Reaction Time   [ Time Frame: 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind) ]

13.  Secondary:   Sedation Score, as Assessed by the Linear Analogue Rating Scales   [ Time Frame: 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind) ]

14.  Secondary:   Mood Score, as Assessed by the Linear Analogue Rating Scales   [ Time Frame: 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind) ]

15.  Secondary:   Coordination Score, as Assessed by the Linear Analogue Rating Scales   [ Time Frame: 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind) ]


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


No publications provided


Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00699608     History of Changes
Other Study ID Numbers: ESZ111503
Study First Received: June 17, 2008
Results First Received: October 6, 2009
Last Updated: March 31, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency