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This study will explore potential next-day residual effects of a single evening dose of 3mg of the hypnotic, eszopiclone, 7.5mg of zopiclone, and placebo, in healthy adult subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Crossover | Experimental | All subjects received all three treatments in a randomised order |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK1755165; placebo; zopiclone | Drug | Subjects receive either 3mg GSK1755165, matching placebo or 7.5mg zopiclone |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Tracking Error Assessed During the Continuous Tracking Test (CTT) | Analysis was performed on the mean of the five assessments conducted 7.5, 8, 8.5, 9, and 9.5 hours post-dose (double-blind) The CTT is a task (duration of 8 minutes) of psychomotor function that entails using a slider to keep a cursor in alignment with a moving target on a visual display unit screen. The movement of the target is the function of an irregular sine wave, and cursor accuracy is measured by the mean tracking error - the difference between the centers of target and cursor in pixels, sampled 5 times per second, over the test. Lower scores are indicative of more accurate tracking. | 7.5, 8, 8.5, 9, and 9.5 hours post-dose (double-blind) |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Tracking Error (MTE) Assessed During the CTT | Analysis was performed on the individual assessments conducted at 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind) . The CTT is a task (8 minute duration) of psychomotor function that entails using a slider to keep a cursor in alignment with a moving target on a visual display unit screen. The movement of the target is the function of an irregular sine wave, and cursor accuracy is measured by the MTE, the difference between the centers of target and cursor in pixels, sampled 5 times per second, over the test. Lower scores are indicative of more accurate tracking. |
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INCLUSION CRITERIA:
EXCLUSION CRITERIA:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Guildford | Surrey | GU2 7XP | United Kingdom |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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) |
| FG001 | 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) |
| FG002 | 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) |
| FG003 | 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) |
| FG004 | 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) |
| FG005 | 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) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
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| ||||||||||||||||||
| First 4-14 Day Washout Period |
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| Second Intervention |
| |||||||||||||||||||
| Second 4-14 Day Washout Period |
| |||||||||||||||||||
| Third Intervention |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Entire Study Population |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Tracking Error Assessed During the Continuous Tracking Test (CTT) | Analysis was performed on the mean of the five assessments conducted 7.5, 8, 8.5, 9, and 9.5 hours post-dose (double-blind) The CTT is a task (duration of 8 minutes) of psychomotor function that entails using a slider to keep a cursor in alignment with a moving target on a visual display unit screen. The movement of the target is the function of an irregular sine wave, and cursor accuracy is measured by the mean tracking error - the difference between the centers of target and cursor in pixels, sampled 5 times per second, over the test. Lower scores are indicative of more accurate tracking. | Intent-to-Treat (ITT) Population: all subjects who gave informed consent, were randomised, and received at least one dose of double-blind medication. Only participants who had assessment of the measure the day after double-blind treatment were analyzed. | Posted | Least Squares Mean | Standard Error | pixels | 7.5, 8, 8.5, 9, and 9.5 hours post-dose (double-blind) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dysgeusia | Nervous system disorders | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C515050 | zopiclone |
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| 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind) |
| CTT Mean Reaction Time | Analysis was performed on the individual assessments conducted at 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind) A further outcome derived from the CTT is a peripheral awareness task where the participant responds to a stimulus presented in the periphery of vision, while simultaneously attending to the tracking test. The mean reaction time, in milliseconds, to these stimuli over the trial period is taken as the response measure for this component of the divided attention task. A lower mean reaction time is indicative of better peripheral awareness. | 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind) |
| Critical Flicker Fusion Test-Ascending Threshold | Critical Flicker Fusion (CFF) is a validated cognitive assessment task that provides an index of central nervous system (CNS) activity and attention modulated motion detection. Participants are required to discriminate flicker from fusion, and vice versa, in a set of four light-emitting diodes arranged in a one-centimetre square. These diodes are held in foveal fixation when viewed at a distance of one metre. Individual thresholds are determined on four ascending and four descending scales. The mean of the four ascending presentations give the ascending threshold frequency in hertz. | 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind) |
| Critical Flicker Fusion Test -Descending Threshold | Analysis was performed on the individual assessments conducted at 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind) The mean of the four descending presentations from the CFF give the descending threshold frequency in hertz. | 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind) |
| Critical Flicker Fusion Test-Overall Threshold | Analysis was performed on the individual assessments conducted at 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind) The mean of the four ascending and four descending presentations of the CFF give the overall threshold frequency in hertz. | 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind) |
| Total Number of Attempted Symbol Substitutions, as Assessed by the Digit Symbol Substitution Test | Analysis was performed on the individual assessments conducted at 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind). The Digit Symbol Substitution Test (DSST) is a pen and paper test that consists of rows of blank squares paired with randomly assigned digits (between 0 and 9). Participants are required to substitute each digit with a different nonsense symbol, according to a key printed at the top of the sheet that indicates the nonsense symbol that corresponds to each digit. Participants are given 120 seconds in which to complete the test. | 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind) |
| Total Number of Correct Symbol Substitutions, as Assessed by the Digital Symbol Substitution Test | Analysis was performed on the individual assessments conducted at 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind). The Digit Symbol Substitution Test (DSST) is a pen and paper test that consists of rows of blank squares paired with randomly assigned digits (between 0 and 9). Participants are required to substitute each digit with a different nonsense symbol, according to a key printed at the top of the sheet that indicates the nonsense symbol that corresponds to each digit. Participants are given 120 seconds in which to complete the test. | 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind) |
| 1-Back Percentage of Correct Responses | The N-Back task requires the participant to indicate, using the mouse, whether the current stimulus presented on the screen and the one immediately before it visually match (i.e., "one-back"). In the versions of the tests used in this study, the stimuli are presented on screen for 500 ms, and the interval between stimuli is 2500 ms, with a ratio of 1:2 of "match" trials to non-match trials. The duration of the test is 2 minutes. The percentage of correct responses is the percentage of correct responses given in 2 minutes. | 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind) |
| 3-Back Percentage of Correct Responses | Analysis was performed on the individual assessments conducted at 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind). In "3-back" tasks, a comparison is made between the current stimulus and the two before the immediately preceding stimulus. In the versions of the tests used in this study, the stimuli are presented on screen for 500 ms, and the interval between stimuli is 2500 ms, with a ratio of 1:2 of "match" trials to non-match trials. The duration of the test is 2 min. The percentage of correct responses is the percentage of correct responses given in 2 min. | 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind) |
| 1-Back Reaction Time | Analysis was performed on the individual assessments conducted at 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind). Reaction time is the time taken to respond to a stimulus. | 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind) |
| 3-Back Reaction Time | Analysis was performed on the individual assessments conducted at 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind). Reaction time is the time taken to respond to a stimulus. | 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind) |
| Sedation Score, as Assessed by the Linear Analogue Rating Scales | The Linear Analogue Rating Scale (LARS) is used as a measure of the subjective effects of psychoactive drugs. Participants mark a series of 10 cm (100 unit line) analogue scales (1-100, 100 = most impaired) relating to dizzy, clumsy, anxious, relaxed, tired, drowsy, alert, energetic, sad, and depressed, indicating their present feeling with regard to a mid-point, representing their "usual" state of mind before treatment began. The higher the score, the more impaired the participant feels. The Tiredness, Alertness, Energy, and Drowsiness scores are averaged to derive an overall Sedation score. | 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind) |
| Mood Score, as Assessed by the Linear Analogue Rating Scales | Analysis was performed on the individual assessments conducted at 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind). The Anxiety, Depression, Relaxed, and Sadness scores are averaged to derive an overall "Mood" score (as described in Outcome Measure 14). Each item was assessed on a 1-100 point scale, where 100 indicates most impaired. | 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind) |
| Coordination Score, as Assessed by the Linear Analogue Rating Scales | Analysis was performed on the individual assessments conducted at 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind). The Dizziness and Clumsiness scores are averaged to derive an overall "Coordination" score (as described in Outcome Measure 14). Each item was assessed on a 1-100 point scale, where 100 indicates most impaired. | 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind) |
| Protocol Violation |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Placebo |
Placebo |
| OG001 | Eszopiclone | 3 mg Eszopiclone |
| OG002 | Zopiclone | 7.5 mg Zopiclone |
|
|
|
| Secondary | Mean Tracking Error (MTE) Assessed During the CTT | Analysis was performed on the individual assessments conducted at 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind) . The CTT is a task (8 minute duration) of psychomotor function that entails using a slider to keep a cursor in alignment with a moving target on a visual display unit screen. The movement of the target is the function of an irregular sine wave, and cursor accuracy is measured by the MTE, the difference between the centers of target and cursor in pixels, sampled 5 times per second, over the test. Lower scores are indicative of more accurate tracking. | Intent-to-Treat (ITT) Population: all participants who gave informed consent, were randomised, and received at least one dose of double-blind study medication. Only participants who had assessment of the measure the day after double-blind treatment were analyzed. | Posted | Least Squares Mean | Standard Error | pixels | 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind) |
|
|
|
| Secondary | CTT Mean Reaction Time | Analysis was performed on the individual assessments conducted at 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind) A further outcome derived from the CTT is a peripheral awareness task where the participant responds to a stimulus presented in the periphery of vision, while simultaneously attending to the tracking test. The mean reaction time, in milliseconds, to these stimuli over the trial period is taken as the response measure for this component of the divided attention task. A lower mean reaction time is indicative of better peripheral awareness. | Intent-to-Treat (ITT) Population: all participants who gave informed consent, were randomised, and received at least one dose of double-blind study medication.Only participants who had assessment of the measure the day after double-blind treatment were analyzed. | Posted | Least Squares Mean | Standard Error | milliseconds | 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind) |
|
|
|
| Secondary | Critical Flicker Fusion Test-Ascending Threshold | Critical Flicker Fusion (CFF) is a validated cognitive assessment task that provides an index of central nervous system (CNS) activity and attention modulated motion detection. Participants are required to discriminate flicker from fusion, and vice versa, in a set of four light-emitting diodes arranged in a one-centimetre square. These diodes are held in foveal fixation when viewed at a distance of one metre. Individual thresholds are determined on four ascending and four descending scales. The mean of the four ascending presentations give the ascending threshold frequency in hertz. | Intent-to-Treat (ITT) Population: all participants who gave informed consent, were randomised, and received at least one dose of double-blind study medication. Only participants who had assessment of the measure the day after double-blind treatment were analyzed. | Posted | Least Squares Mean | Standard Error | hertz | 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind) |
|
|
|
| Secondary | Critical Flicker Fusion Test -Descending Threshold | Analysis was performed on the individual assessments conducted at 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind) The mean of the four descending presentations from the CFF give the descending threshold frequency in hertz. | Intent-to-Treat (ITT) Population: all participants who gave informed consent, were randomised, and received at least one dose of double-blind study medication.Only participants who had assessment of the measure the day after double-blind treatment were analyzed. | Posted | Least Squares Mean | Standard Error | hertz | 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind) |
|
|
|
| Secondary | Critical Flicker Fusion Test-Overall Threshold | Analysis was performed on the individual assessments conducted at 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind) The mean of the four ascending and four descending presentations of the CFF give the overall threshold frequency in hertz. | Intent-to-Treat (ITT) Population: all participants who gave informed consent, were randomised, and received at least one dose of double-blind study medication. Only participants who had assessment of the measure the day after double-blind treatment were analyzed. | Posted | Least Squares Mean | Standard Error | hertz | 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind) |
|
|
|
| Secondary | Total Number of Attempted Symbol Substitutions, as Assessed by the Digit Symbol Substitution Test | Analysis was performed on the individual assessments conducted at 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind). The Digit Symbol Substitution Test (DSST) is a pen and paper test that consists of rows of blank squares paired with randomly assigned digits (between 0 and 9). Participants are required to substitute each digit with a different nonsense symbol, according to a key printed at the top of the sheet that indicates the nonsense symbol that corresponds to each digit. Participants are given 120 seconds in which to complete the test. | Intent-to-Treat (ITT) Population: all participants who gave informed consent, were randomised, and received at least one dose of double-blind study medication. Only participants who had assessment of the measure the day after double-blind treatment were analyzed. | Posted | Least Squares Mean | Standard Error | number of substitutions | 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind) |
|
|
|
| Secondary | Total Number of Correct Symbol Substitutions, as Assessed by the Digital Symbol Substitution Test | Analysis was performed on the individual assessments conducted at 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind). The Digit Symbol Substitution Test (DSST) is a pen and paper test that consists of rows of blank squares paired with randomly assigned digits (between 0 and 9). Participants are required to substitute each digit with a different nonsense symbol, according to a key printed at the top of the sheet that indicates the nonsense symbol that corresponds to each digit. Participants are given 120 seconds in which to complete the test. | Intent-to-Treat (ITT) Population: all participants who gave informed consent, were randomised, and received at least one dose of double-blind study medication. Only participants who had assessment of the measure the day after double-blind treatment were analyzed. | Posted | Least Squares Mean | Standard Error | number of substitutions | 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind) |
|
|
|
| Secondary | 1-Back Percentage of Correct Responses | The N-Back task requires the participant to indicate, using the mouse, whether the current stimulus presented on the screen and the one immediately before it visually match (i.e., "one-back"). In the versions of the tests used in this study, the stimuli are presented on screen for 500 ms, and the interval between stimuli is 2500 ms, with a ratio of 1:2 of "match" trials to non-match trials. The duration of the test is 2 minutes. The percentage of correct responses is the percentage of correct responses given in 2 minutes. | Intent-to-Treat (ITT) Population: all participants who gave informed consent, were randomised, and received at least one dose of double-blind study medication. Only participants who had assessment of the measure the day after double-blind treatment were analyzed. | Posted | Least Squares Mean | Standard Error | percentage of responses | 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind) |
|
|
|
| Secondary | 3-Back Percentage of Correct Responses | Analysis was performed on the individual assessments conducted at 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind). In "3-back" tasks, a comparison is made between the current stimulus and the two before the immediately preceding stimulus. In the versions of the tests used in this study, the stimuli are presented on screen for 500 ms, and the interval between stimuli is 2500 ms, with a ratio of 1:2 of "match" trials to non-match trials. The duration of the test is 2 min. The percentage of correct responses is the percentage of correct responses given in 2 min. | Intent-to-Treat (ITT) Population: all participants who gave informed consent, were randomised, and received at least one dose of double-blind study medication. Only participants who had assessment of the measure the day after double-blind treatment were analyzed. | Posted | Least Squares Mean | Standard Error | percentage of responses | 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind) |
|
|
|
| Secondary | 1-Back Reaction Time | Analysis was performed on the individual assessments conducted at 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind). Reaction time is the time taken to respond to a stimulus. | Intent-to-Treat (ITT) Population: all participants who gave informed consent, were randomised, and received at least one dose of double-blind study medication. Only participants who had assessment of the measure the day after double-blind treatment were analyzed. | Posted | Least Squares Mean | Standard Error | milliseconds | 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind) |
|
|
|
| Secondary | 3-Back Reaction Time | Analysis was performed on the individual assessments conducted at 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind). Reaction time is the time taken to respond to a stimulus. | Intent-to-Treat (ITT) Population: all participants who gave informed consent, were randomised, and received at least one dose of double-blind study medication. Only participants who had assessment of the measure the day after double-blind treatment were analyzed. | Posted | Least Squares Mean | Standard Error | milliseconds | 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind) |
|
|
|
| Secondary | Sedation Score, as Assessed by the Linear Analogue Rating Scales | The Linear Analogue Rating Scale (LARS) is used as a measure of the subjective effects of psychoactive drugs. Participants mark a series of 10 cm (100 unit line) analogue scales (1-100, 100 = most impaired) relating to dizzy, clumsy, anxious, relaxed, tired, drowsy, alert, energetic, sad, and depressed, indicating their present feeling with regard to a mid-point, representing their "usual" state of mind before treatment began. The higher the score, the more impaired the participant feels. The Tiredness, Alertness, Energy, and Drowsiness scores are averaged to derive an overall Sedation score. | Intent-to-Treat (ITT) Population: all participants who gave informed consent, were randomised, and received at least one dose of double-blind study medication. Only participants who had assessment of the measure the day after double-blind treatment were analyzed. | Posted | Least Squares Mean | Standard Error | points on a scale | 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind) |
|
|
|
| Secondary | Mood Score, as Assessed by the Linear Analogue Rating Scales | Analysis was performed on the individual assessments conducted at 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind). The Anxiety, Depression, Relaxed, and Sadness scores are averaged to derive an overall "Mood" score (as described in Outcome Measure 14). Each item was assessed on a 1-100 point scale, where 100 indicates most impaired. | Intent-to-Treat (ITT) Population: all participants who gave informed consent, were randomised, and received at least one dose of double-blind study medication. Only participants who had assessment of the measure the day after double-blind treatment were analyzed. | Posted | Least Squares Mean | Standard Error | points on a scale | 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind) |
|
|
|
| Secondary | Coordination Score, as Assessed by the Linear Analogue Rating Scales | Analysis was performed on the individual assessments conducted at 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind). The Dizziness and Clumsiness scores are averaged to derive an overall "Coordination" score (as described in Outcome Measure 14). Each item was assessed on a 1-100 point scale, where 100 indicates most impaired. | Intent-to-Treat (ITT) Population: all participants who gave informed consent, were randomised, and received at least one dose of double-blind study medication. Only participants who had assessment of the measure the day after double-blind treatment were analyzed. | Posted | Least Squares Mean | Standard Error | points on a scale | 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind) |
|
|
|
| 0 |
| 89 |
| 12 |
| 89 |
| EG001 | Eszopiclone | 3 mg Eszopiclone | 0 | 88 | 44 | 88 |
| EG002 | Zopiclone | 7.5 mg Zopiclone | 0 | 90 | 44 | 90 |
| Somnolence | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Disturbance in attention | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Balance disorder | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Coordination abnormal | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Memory impairment | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Poor quality sleep | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Frequent bowel movements | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Gastrointestinal sounds abnormal | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Hallucination | Psychiatric disorders | MedDRA | Systematic Assessment |
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| Nightmare | Psychiatric disorders | MedDRA | Systematic Assessment |
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| Depressed mood | Psychiatric disorders | MedDRA | Systematic Assessment |
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| Fear | Psychiatric disorders | MedDRA | Systematic Assessment |
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| Somnambulism | Psychiatric disorders | MedDRA | Systematic Assessment |
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| Dry throat | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Pruritis | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
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| Eye pain | Eye disorders | MedDRA | Systematic Assessment |
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| Eye pruritis | Eye disorders | MedDRA | Systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Skin laceration | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D001523 |
| Mental Disorders |
|
| 8.5 hours post-dose |
|
| 9 hours post-dose |
|
| 9.5 hours post-dose |
|
| 10 hours post-dose |
|
| 10.5 hours post-dose |
|
| 11 hours post-dose |
|
| 11.5 hours post-dose |
|
|
| 8.5 hours post-dose, n=89, 87, 90 |
|
| 9 hours post-dose, n=89, 87, 90 |
|
| 9.5 hours post-dose, n=89, 87, 90 |
|
| 10 hours post-dose, n=89, 87, 90 |
|
| 10.5 hours post-dose, n=89, 87, 90 |
|
| 11 hours post-dose, n=89, 87, 90 |
|
| 11.5 hours post-dose, n=89, 87, 90 |
|
|
| 8.5 hours post-dose, n=89, 87, 90 |
|
| 9 hours post-dose, n=89, 87, 90 |
|
| 9.5 hours post-dose, n=89, 87, 90 |
|
| 10 hours post-dose, n=89, 87, 90 |
|
| 10.5 hours post-dose, n=89, 87, 89 |
|
| 11 hours post-dose, n=89, 87, 90 |
|
| 11.5 hours post-dose, n=89, 87, 90 |
|
|
| 8.5 hours post-dose, n=89, 87, 90 |
|
| 9 hours post-dose, n=89, 87, 90 |
|
| 9.5 hours post-dose, n=89, 87, 90 |
|
| 10 hours post-dose, n=89, 87, 90 |
|
| 10.5 hours post-dose, n=89, 87, 89 |
|
| 11 hours post-dose, n=89, 87, 90 |
|
| 11.5 hours post-dose, n=89, 87, 90 |
|
|
| 8.5 hours post-dose, n=89, 87, 90 |
|
| 9 hours post-dose, n=89, 87, 90 |
|
| 9.5 hours post-dose, n=89, 87, 90 |
|
| 10 hours post-dose, n=89, 87, 90 |
|
| 10.5 hours post-dose, n=89, 87, 89 |
|
| 11 hours post-dose, n=89, 87, 90 |
|
| 11.5 hours post-dose, n=89, 87, 90 |
|
|
| 8.5 hours post-dose, n=89, 87, 90 |
|
| 9 hours post-dose, n=88, 87, 90 |
|
| 9.5 hours post-dose, n=88, 87, 90 |
|
| 10 hours post-dose, n=89, 87, 90 |
|
| 10.5 hours post-dose, n=86, 85, 88 |
|
| 11 hours post-dose, n=88, 87, 90 |
|
| 11.5 hours post-dose, n=89, 87, 90 |
|
|
| 8.5 hours post-dose, n=89, 87, 90 |
|
| 9 hours post-dose, n=88, 87, 90 |
|
| 9.5 hours post-dose, n=88, 87, 90 |
|
| 10 hours post-dose, n=89, 87, 90 |
|
| 10.5 hours post-dose, n=86, 85, 88 |
|
| 11 hours post-dose, n=88, 87, 90 |
|
| 11.5 hours post-dose, n=89, 87, 90 |
|
|
| 8.5 hours post-dose, n=89, 87, 90 |
|
| 9 hours post-dose, n=89, 87, 90 |
|
| 9.5 hours post-dose, n=89, 86, 90 |
|
| 10 hours post-dose, n=89, 87, 90 |
|
| 10.5 hours post-dose, n=89, 86, 89 |
|
| 11 hours post-dose, n=89, 87, 90 |
|
| 11.5 hours post-dose, n=89, 87, 90 |
|
|
| 8.5 hours post-dose, n=89, 87, 90 |
|
| 9 hours post-dose, n=89, 87, 90 |
|
| 9.5 hours post-dose, n=89, 86, 90 |
|
| 10 hours post-dose, n=89, 87, 90 |
|
| 10.5 hours post-dose, n=89, 86, 89 |
|
| 11 hours post-dose, n=89, 87, 90 |
|
| 11.5 hours post-dose, n=89, 87, 90 |
|
|
| 8.5 hours post-dose, n=89, 87, 90 |
|
| 9 hours post-dose, n=89, 87, 90 |
|
| 9.5 hours post-dose, n=89, 86, 90 |
|
| 10 hours post-dose, n=89, 87, 90 |
|
| 10.5 hours post-dose, n=89, 86, 89 |
|
| 11 hours post-dose, n=89, 87, 90 |
|
| 11.5 hours post-dose, n=89, 87, 90 |
|
|
| 8.5 hours post-dose, n=89, 87, 90 |
|
| 9 hours post-dose, n=89, 87, 90 |
|
| 9.5 hours post-dose, n=89, 86, 90 |
|
| 10 hours post-dose, n=89, 87, 90 |
|
| 10.5 hours post-dose, n=89, 86, 89 |
|
| 11 hours post-dose, n=89, 87, 90 |
|
| 11.5 hours post-dose, n=89, 87, 90 |
|
|
| 8.5 hours post-dose, n=89, 87, 90 |
|
| 9 hours post-dose, n=89, 87, 90 |
|
| 9.5 hours post-dose, n=89, 87, 90 |
|
| 10 hours post-dose, n=89, 87, 90 |
|
| 10.5 hours post-dose, n=89, 87, 90 |
|
| 11 hours post-dose, n=89, 87, 90 |
|
| 11.5 hours post-dose, n=89, 87, 90 |
|
|
| 8.5 hours post-dose, n=89, 87, 90 |
|
| 9 hours post-dose, n=89, 87, 90 |
|
| 9.5 hours post-dose, n=89, 87, 90 |
|
| 10 hours post-dose, n=89, 87, 90 |
|
| 10.5 hours post-dose, n=89, 87, 90 |
|
| 11 hours post-dose, n=89, 87, 90 |
|
| 11.5 hours post-dose, n=89, 87, 90 |
|
|
| 8.5 hours post-dose, n=89, 87, 90 |
|
| 9 hours post-dose, n=89, 87, 90 |
|
| 9.5 hours post-dose, n=89, 87, 90 |
|
| 10 hours post-dose, n=89, 87, 90 |
|
| 10.5 hours post-dose, n=89, 87, 90 |
|
| 11 hours post-dose, n=89, 87, 90 |
|
| 11.5 hours post-dose, n=89, 87, 90 |
|