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| 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
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
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| No text entered. |
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
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| No text entered. |
| 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) |
| 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 |
| 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 |
| 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 |
| 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 |
| 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
| Description | |
|---|---|
| Entire Study Population | No text entered. |
| 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
| 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) ] |
More Information
| 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:
|
| 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 |
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| No text entered. |
| 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 |