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Trial record 4 of 120 for:    ZOLPIDEM AND AIDS

Driving Performance After Middle of the Night Administration of 3.5 mg Zolpidem Tartrate Sublingual Tablet

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01106859
Recruitment Status : Completed
First Posted : April 20, 2010
Results First Posted : January 20, 2012
Last Update Posted : February 14, 2012
Sponsor:
Information provided by (Responsible Party):
Transcept Pharmaceuticals

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Insomnia
Interventions Drug: zopiclone
Drug: zolpidem tartrate sublingual tablet
Drug: Placebo (sublingual tablet)
Drug: Placebo
Enrollment 40
Recruitment Details  
Pre-assignment Details Forty-four candidates were screened. Four screening failures: high blood pressure (2), positive drug test (1), personal reasons (1)
Arm/Group Title Total Population
Hide Arm/Group Description All participants in this four-way cross-over study
Period Title: Overall Study
Started 40 [1]
Completed 40
Not Completed 0
[1]
Intent to treat population and safety population are the same (40 participants)
Arm/Group Title Total Population
Hide Arm/Group Description All participants in this four-way cross-over study
Overall Number of Baseline Participants 40
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 40 participants
37  (15)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants
Female
20
  50.0%
Male
20
  50.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
40
 100.0%
Unknown or Not Reported
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 40 participants
White 39
Black 0
Asian 0
Other 1
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Netherlands Number Analyzed 40 participants
40
Height  
Mean (Standard Deviation)
Unit of measure:  Centimeters
Number Analyzed 40 participants
176  (9)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilograms
Number Analyzed 40 participants
Male 79  (8)
Female 65  (8)
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kilograms/meter^2
Number Analyzed 40 participants
23.2  (2.4)
1.Primary Outcome
Title Number of Participants Whose Standard Deviation of Lateral Position (SDLP) Following Active Treatment As Compared to Placebo In Relation To The 2.5 cm SDLP Threshold
Hide Description SDLP was measured by an infrared camera mounted on the car’s roof during a highway driving test. Lateral position of the car relative to the left lane boundary was recorded. The data summarizes the number of participants whose driving performance was worse, neutral or improved as compared to placebo at the 2.5 cm threshold. A neutral driving performance shows a difference of SDLP >= 2.5 cm and <= -2.5 cm when compared to placebo. A worse performance is when the difference of SDLP > 2.5 cm, and an improved performance is when the difference of SDLP < -2.5 cm.
Time Frame 3-9 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population
Arm/Group Title Zolpidem 4 Hours Prior Zolpidem 3 Hours Prior Zopiclone
Hide Arm/Group Description:
A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is 3.5 mg zolpidem tartrate sublingual tablet taken 4 hours prior to driving.
A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is 3.5 mg zolpidem tartrate sublingual tablet taken 3 hours prior to driving.
Zopiclone (7.5 mg tablet) is taken at bedtime 9 hours before driving. The middle-of-the-night medication is a placebo matching zolpidem tartrate sublingual tablet.
Overall Number of Participants Analyzed 40 40 40
Measure Type: Number
Unit of Measure: participants
Impaired 5 10 18
Neutral 34 29 22
Improved 1 1 0
2.Primary Outcome
Title Probability of Differences From Placebo Exceeding The 2.5 cm Threshold in Standard Deviation of Lateral Position (SDLP) Following Administration of Active Therapy
Hide Description

This table represents the probability of driving performance changes summarized in the previous table. It answers the question: What is the chance that # participants out of the total number of participants had better (or worse) driving performance? Probability values of <.001 are listed in the data table as 0.000.

A symmetry analysis was conducted for the probability of difference in mean SDLP (treatment) - mean SDLP (placebo) exceeding thresholds. Statistically significant asymmetries indicate a decrement in driving performance.

Time Frame 3-9 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population
Arm/Group Title Zolpidem 4 Hours Prior Zolpidem 3 Hours Prior Zopiclone Placebo
Hide Arm/Group Description:
A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is 3.5 mg zolpidem tartrate sublingual tablet taken 4 hours prior to driving.
A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is 3.5 mg zolpidem tartrate sublingual tablet taken 3 hours prior to driving.
Zopiclone (7.5 mg tablet) is taken at bedtime 9 hours before driving. The middle-of-the-night medication is a placebo matching zolpidem tartrate sublingual tablet.
A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is a placebo matching zolpidem tartrate sublingual tablet.
Overall Number of Participants Analyzed 40 40 40 40
Measure Type: Number
Unit of Measure: proportion
Probability - impaired 0.125 0.250 0.450 NA [1] 
Probability - improved 0.025 0.025 0.000 NA [1] 
[1]
Probability for the active treatment arms uses the Placebo experience as a base case from which to calculate probability.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Zolpidem 4 Hours Prior, Placebo
Comments Symmetry analysis was performed for the probability of difference from placebo falling above and below the threshold of +/-2.5 cm in Standard Deviation of Lateral Position (SDLP) following administration of zolpidem tartrate sublingual tablet 4 hours prior to driving. Statistically significant asymmetries indicate a decrement in driving performance. Lack of statistical significance indicates symmetry which shows a lack of treatment effect on driving performance.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2188
Comments No adjustments. The a priori threshold for statistical significance is 0.05.
Method McNemar
Comments McNemar's exact test with one degree of freedom is used.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Zolpidem 3 Hours Prior, Placebo
Comments Symmetry analysis was performed for the probability of difference from placebo falling above and below the threshold of +/-2.5 cm in Standard Deviation of Lateral Position (SDLP) following administration of zolpidem tartrate sublingual tablet 3 hours prior to driving. Statistically significant asymmetries indicate a decrement in driving performance. Lack of statistical significance indicates symmetry which shows a lack of treatment effect on driving performance.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0117
Comments No adjustments. The a priori threshold for statistical significance is 0.05.
Method McNemar
Comments McNemar's exact test with one degree of freedom is used.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Zopiclone, Placebo
Comments Symmetry analysis was performed for the probability of difference from placebo falling above and below the threshold of +/-2.5 cm in Standard Deviation of Lateral Position (SDLP) following administration of zopiclone 9 hours prior to driving. Statistically significant asymmetries indicate a decrement in driving performance. Lack of statistical significance indicates symmetry which shows a lack of treatment effect on driving performance.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments No adjustments. The a priori threshold for statistical significance is 0.05.
Method McNemar
Comments McNemar's exact test with one degree of freedom is used.
3.Secondary Outcome
Title Mean Standard Deviation of Lateral Position (SDLP) in the Highway Driving Test
Hide Description Standard deviation of lateral position (SDLP) in a highway-driving lane is a surrogate measure for driving performance. It measures the driver's ability to stay in a constant position within the driving lane. Variations in the lateral position are recorded and analyzed.
Time Frame 3-9 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population
Arm/Group Title Zolpidem 4 Hours Prior Zolpidem 3 Hours Prior Zopiclone Placebo
Hide Arm/Group Description:
A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is 3.5 mg zolpidem tartrate sublingual tablet taken 4 hours prior to driving.
A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is 3.5 mg zolpidem tartrate sublingual tablet taken 3 hours prior to driving.
Zopiclone (7.5 mg tablet) is taken at bedtime 9 hours before driving. The middle-of-the-night medication is a placebo matching zolpidem tartrate sublingual tablet.
A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is a placebo matching zolpidem tartrate sublingual tablet.
Overall Number of Participants Analyzed 40 40 40 40
Least Squares Mean (Standard Error)
Unit of Measure: centimeters
16.7  (0.60) 17.3  (0.60) 18.3  (0.60) 15.9  (0.60)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Zolpidem 4 Hours Prior, Placebo
Comments P-value is based on ANOVA model with fixed effects for sequence, period and treatment, a random effect for subject within sequence, and assuming compound symmetry covariance structure; the p-value is reported from LS Mean difference between Treatment Groups: LS mean of SDLP (Zolpidem 4 Hours) – LS mean of SDLP (Placebo).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0174
Comments No p-value adjustment for multiple comparisons.
Method ANOVA
Comments The degrees of freedom are 114 for the p-value testing the difference between treatment groups.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.8
Confidence Interval (2-Sided) 95%
0.1 to 1.5
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Zolpidem 3 Hours Prior, Placebo
Comments P-value is based on ANOVA model with fixed effects for sequence, period and treatment, a random effect for subject within sequence, and assuming compound symmetry covariance structure; the p-value is reported from LS Mean difference between Treatment Groups: LS mean of SDLP (Zolpidem 3 Hours) – LS mean of SDLP (Placebo).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments No p-value adjustment for multiple comparisons.
Method ANOVA
Comments The degrees of freedom are 114 for the p-value testing the difference between treatment groups
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.5
Confidence Interval (2-Sided) 95%
0.8 to 2.1
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Zopiclone, Placebo
Comments P-value is based on ANOVA model with fixed effects for sequence, period and treatment, a random effect for subject within sequence, and assuming compound symmetry covariance structure; the p-value is reported from LS Mean difference between Treatment Groups: LS mean of SDLP (Zopiclone) – LS mean of SDLP (Placebo).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments No p-value adjustment for multiple comparisons
Method ANOVA
Comments The degrees of freedom are 114 for the p-value testing the difference between treatment groups
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.5
Confidence Interval (2-Sided) 95%
1.8 to 3.1
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Mean Standard Deviation of Speed (SDS) in the Highway Drive Test
Hide Description Mean standard deviation of speed (SDS) is a common measure of the driver's ability to maintain a constant driving speed. Variations in driving speed are recorded and analyzed.
Time Frame 3-9 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population. In one Zopiclone case, the velocity of the car was not recorded due to technical problems, and therefore SDS could not be calculated in this drive.
Arm/Group Title Zolpidem 4 Hours Prior Zolpidem 3 Hours Prior Zopiclone Placebo
Hide Arm/Group Description:
A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is 3.5 mg zolpidem tartrate sublingual tablet taken 4 hours prior to driving.
A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is zolpidem tartrate sublingual tablet taken 3 hours prior to driving.
Zopiclone (7.5 mg tablet) is taken at bedtime 9 hours before driving. The middle-of-the-night medication is a placebo matching zolpidem tartrate sublingual tablet.
A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is a placebo matching zolpidem tartrate sublingual tablet.
Overall Number of Participants Analyzed 40 40 39 40
Least Squares Mean (Standard Error)
Unit of Measure: kilometers/hour
1.98  (0.08) 1.91  (0.08) 1.99  (0.08) 1.83  (0.08)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Zolpidem 4 Hours Prior, Placebo
Comments P-value is based on ANOVA model with fixed effects for sequence, period and treatment, a random effect for subject within sequence, and assuming compound symmetry covariance structure; the p-value is reported from LS Mean difference between Treatment Groups: LS mean of SDS (Zolpidem 4 hours prior) – LS mean of SDS (Placebo).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0145
Comments No p-value adjustment for multiple comparisons
Method ANOVA
Comments The degrees of freedom are 113 for the p-value testing the difference between treatment groups
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.15
Confidence Interval (2-Sided) 95%
0.03 to 0.27
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Zolpidem 3 Hours Prior, Placebo
Comments P-value is based on ANOVA model with fixed effects for sequence, period and treatment, a random effect for subject within sequence, and assuming compound symmetry covariance structure; the p-value is reported from LS Mean difference between Treatment Groups: LS mean of SDS (Zolpidem 3 Hours) – LS mean of SDS (Placebo).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2179
Comments No p-value adjustment for multiple comparisons
Method ANOVA
Comments The degrees of freedom are 113 for the p-value testing the difference between treatment groups
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.08
Confidence Interval (2-Sided) 95%
-0.05 to 0.20
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Zopiclone, Placebo
Comments P-value is based on ANOVA model with fixed effects for sequence, period and treatment, a random effect for subject within sequence, and assuming compound symmetry covariance structure; the p-value is reported from LS Mean difference between Treatment Groups: LS mean of SDS (Zopiclone) – LS mean of SDS (Placebo).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0096
Comments No p-value adjustment for multiple comparisons
Method ANOVA
Comments The degrees of freedom are 113 for the p-value testing the difference between treatment groups
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.16
Confidence Interval (2-Sided) 95%
0.04 to 0.29
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Summary of Participants With Treatment Emergent Adverse Experiences (TEAEs)
Hide Description Adverse Events were graded by the investigator using the World Health Organization (WHO) Adverse Event Grading Scale and were assessed for severity (mild, moderate, severe) and relatedness (summarized as 'unrelated' and 'related') to study treatment. Also included are counts of participants with serious AEs, AEs leading to discontinuation of study treatment, and deaths.
Time Frame Day 1 -6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population (participants who were randomized and received at least one dose of study drug)
Arm/Group Title Zolpidem 4 Hours Prior Zolpidem 3 Hours Prior Zopiclone Placebo
Hide Arm/Group Description:
A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is 3.5 mg zolpidem tartrate sublingual tablet taken 4 hours prior to driving.
A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is zolpidem tartrate sublingual tablet taken 3 hours prior to driving.
Zopiclone (7.5 mg tablet) is taken at bedtime 9 hours before driving. The middle-of-the-night medication is a placebo matching zolpidem tartrate sublingual tablet.
A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is a placebo matching zolpidem tartrate sublingual tablet.
Overall Number of Participants Analyzed 40 40 40 40
Measure Type: Number
Unit of Measure: participants
At least one TEAE 5 5 6 4
TEAE graded as mild 4 5 6 4
TEAE graded as moderate 1 0 0 0
TEAE graded as severe 0 0 0 0
Unrelated 3 2 4 1
Related 2 3 2 3
At least one serious AE 0 0 0 0
Discontinued study medication due to AE 0 0 0 0
Death 0 0 0 0
6.Secondary Outcome
Title Number of Participants Whose Standard Deviation of Lateral Position (SDLP) Following Active Treatment As Compared to Placebo In Relation To The 2.0 cm SDLP Threshold
Hide Description SDLP was measured by an infrared camera mounted on the car's roof during a highway driving test. Lateral position of the car relative to the left lane boundary was recorded. The data summarizes the number of participants whose driving performance was worse, neutral or improved as compared to placebo at the 2.0 cm threshold. A neutral driving performance shows a difference of SDLP >= 2.0 cm and <= -2.0 cm when compared to placebo. A worse performance is when the difference of SDLP > 2.0 cm, and an improved performance is when the difference of SDLP < -2.0 cm.
Time Frame 3-9 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population
Arm/Group Title Zolpidem 4 Hours Prior Zolpidem 3 Hours Prior Zopiclone
Hide Arm/Group Description:
A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is 3.5 mg zolpidem tartrate sublingual tablet taken 4 hours prior to driving.
A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is 3.5 mg zolpidem tartrate sublingual tablet taken 3 hours prior to driving.
Zopiclone (7.5 mg tablet) is taken at bedtime 9 hours before driving. The middle-of-the-night medication is a placebo matching zolpidem tartrate sublingual tablet.
Overall Number of Participants Analyzed 40 40 40
Measure Type: Number
Unit of Measure: participants
Impaired 6 13 19
Neutral 33 25 21
Improved 1 2 0
7.Secondary Outcome
Title Probability of Differences From Placebo Exceeding The 2.0 cm Threshold in Standard Deviation of Lateral Position (SDLP) Following Administration of Active Therapy
Hide Description

This table represents the probability of driving performance changes summarized in the previous table. It answers the question: What is the chance that # participants out of the total number of participants had better (or worse) driving performance? Probability values of <.001 are listed in the data table as 0.000.

A symmetry analysis was conducted for the probability of difference in mean SDLP (treatment) - mean SDLP (placebo) exceeding thresholds. Statistically significant asymmetries indicate a decrement in driving performance.

Time Frame 3-9 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population
Arm/Group Title Zolpidem 4 Hours Prior Zolpidem 3 Hours Prior Zopiclone Placebo
Hide Arm/Group Description:
A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is 3.5 mg zolpidem tartrate sublingual tablet taken 4 hours prior to driving.
A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is 3.5 mg zolpidem tartrate sublingual tablet taken 3 hours prior to driving.
Zopiclone (7.5 mg tablet) is taken at bedtime 9 hours before driving. The middle-of-the-night medication is a placebo matching zolpidem tartrate sublingual tablet.
A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is a placebo matching zolpidem tartrate sublingual tablet.
Overall Number of Participants Analyzed 40 40 40 40
Measure Type: Number
Unit of Measure: proportion
Probability - impaired 0.150 0.325 0.475 NA [1] 
Probability - improved 0.025 0.050 0.000 NA [1] 
[1]
Probability for the active treatment arms uses the Placebo experience as a base case from which to calculate probability.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Zolpidem 4 Hours Prior, Placebo
Comments Symmetry analysis was performed for the probability of difference from placebo falling above and below the threshold of +/-2.0 cm in Standard Deviation of Lateral Position (SDLP) following administration of zolpidem tartrate sublingual tablet 4 hours prior to driving. Statistically significant asymmetries indicate a decrement in driving performance. Lack of statistical significance indicates symmetry which shows a lack of treatment effect on driving performance.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1250
Comments No adjustments. The a priori threshold for statistical significance is 0.05.
Method McNemar
Comments McNemar's exact test with one degree of freedom is used.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Zolpidem 3 Hours Prior, Placebo
Comments Symmetry analysis was performed for the probability of difference from placebo falling above and below the threshold of +/-2.0 cm in Standard Deviation of Lateral Position (SDLP) following administration of zolpidem tartrate sublingual tablet 3 hours prior to driving. Statistically significant asymmetries indicate a decrement in driving performance. Lack of statistical significance indicates symmetry which shows a lack of treatment effect on driving performance.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0074
Comments No adjustments. The a priori threshold for statistical significance is 0.05.
Method McNemar
Comments McNemar's exact test with one degree of freedom is used.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Zopiclone, Placebo
Comments Symmetry analysis was performed for the probability of difference from placebo falling above and below the threshold of +/-2.0 cm in Standard Deviation of Lateral Position (SDLP) following administration of Zopiclone 9 hours prior to driving. Statistically significant asymmetries indicate a decrement in driving performance. Lack of statistical significance indicates symmetry which shows a lack of treatment effect on driving performance.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments No adjustments. The a priori threshold for statistical significance is 0.05.
Method McNemar
Comments McNemar's exact test with one degree of freedom is used.
8.Secondary Outcome
Title Number of Participants Whose Standard Deviation of Lateral Position (SDLP) Following Active Treatment As Compared to Placebo In Relation To The 3.5 cm SDLP Threshold
Hide Description SDLP was measured by an infrared camera mounted on the car's roof during a highway driving test. Lateral position of the car relative to the left lane boundary was recorded. The data summarizes the number of participants whose driving performance was worse, neutral or improved as compared to placebo at the 3.5 cm threshold. A neutral driving performance shows a difference of SDLP >= 3.5 cm and <= -3.5 cm when compared to placebo. A worse performance is when the difference of SDLP > 3.5 cm, and an improved performance is when the difference of SDLP < -3.5 cm.
Time Frame 3-9 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population
Arm/Group Title Zolpidem 4 Hours Prior Zolpidem 3 Hours Prior Zopiclone
Hide Arm/Group Description:
A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is 3.5 mg zolpidem tartrate sublingual tablet taken 4 hours prior to driving.
A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is 3.5 mg zolpidem tartrate sublingual tablet taken 3 hours prior to driving.
Zopiclone (7.5 mg tablet) is taken at bedtime 9 hours before driving. The middle-of-the-night medication is a placebo matching zolpidem tartrate sublingual tablet.
Overall Number of Participants Analyzed 40 40 40
Measure Type: Number
Unit of Measure: participants
Impaired 2 7 14
Neutral 38 33 26
Improved 0 0 0
9.Secondary Outcome
Title Probability of Differences From Placebo Exceeding The 3.5 cm Threshold in Standard Deviation of Lateral Position (SDLP) Following Administration of Active Therapy
Hide Description

This table represents the probability of driving performance changes summarized in the previous table. It answers the question: What is the chance that # participants out of the total number of participants had better (or worse) driving performance? Probability values of <.001 are listed in the data table as 0.000.

A symmetry analysis was conducted for the probability of difference in mean SDLP (treatment) - mean SDLP (placebo) exceeding thresholds. Statistically significant asymmetries indicate a decrement in driving performance.

Time Frame 3-9 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population
Arm/Group Title Zolpidem 4 Hours Prior Zolpidem 3 Hours Prior Zopiclone Placebo
Hide Arm/Group Description:
A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is 3.5 mg zolpidem tartrate sublingual tablet taken 4 hours prior to driving.
A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is 3.5 mg zolpidem tartrate sublingual tablet taken 3 hours prior to driving.
Zopiclone (7.5 mg tablet) is taken at bedtime 9 hours before driving. The middle-of-the-night medication is a placebo matching zolpidem tartrate sublingual tablet.
A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is a placebo matching zolpidem tartrate sublingual tablet.
Overall Number of Participants Analyzed 40 40 40 40
Measure Type: Number
Unit of Measure: proportion
Probability - impaired 0.050 0.175 0.350 NA [1] 
Probability - improved 0.000 0.000 0.000 NA [1] 
[1]
Probability for the active treatment arms uses the Placebo experience as a base case from which to calculate probability.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Zolpidem 4 Hours Prior, Placebo
Comments Symmetry analysis was performed for the probability of difference from placebo falling above and below the threshold of +/-3.5 cm in Standard Deviation of Lateral Position (SDLP) following administration of zolpidem tartrate sublingual tablet 4 hours prior to driving. Statistically significant asymmetries indicate a decrement in driving performance. Lack of statistical significance indicates symmetry which shows a lack of treatment effect on driving performance.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5000
Comments No adjustments. The a priori threshold for statistical significance is 0.05.
Method McNemar
Comments McNemar's exact test with one degree of freedom is used.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Zolpidem 3 Hours Prior, Placebo
Comments Symmetry analysis was performed for the probability of difference from placebo falling above and below the threshold of +/-3.5 cm in Standard Deviation of Lateral Position (SDLP) following administration of zolpidem tartrate sublingual tablet 3 hours prior to driving. Statistically significant asymmetries indicate a decrement in driving performance. Lack of statistical significance indicates symmetry which shows a lack of treatment effect on driving performance.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0156
Comments No adjustments. The a priori threshold for statistical significance is 0.05.
Method McNemar
Comments McNemar's exact test with one degree of freedom is used.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Zopiclone, Placebo
Comments Symmetry analysis was performed for the probability of difference from placebo falling above and below the threshold of +/-3.5 cm in Standard Deviation of Lateral Position (SDLP) following administration of zopiclone 9 hours prior to driving. Statistically significant asymmetries indicate a decrement in driving performance. Lack of statistical significance indicates symmetry which shows a lack of treatment effect on driving performance.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments No adjustments. The a priori threshold for statistical significance is 0.05.
Method McNemar
Comments McNemar's exact test with one degree of freedom is used.
Time Frame Treatment emergent AEs (Day 1 to Week 6)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Zolpidem 4 Hours Prior Zolpidem 3 Hours Prior Zopiclone Placebo
Hide Arm/Group Description A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is 3.5 mg zolpidem tartrate sublingual tablet taken 4 hours prior to driving. A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is zolpidem tartrate sublingual tablet taken 3 hours prior to driving. Zopiclone (7.5 mg tablet) is taken at bedtime 9 hours before driving. The middle-of-the-night medication is a placebo matching zolpidem tartrate sublingual tablet. A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is a placebo matching zolpidem tartrate sublingual tablet.
All-Cause Mortality
Zolpidem 4 Hours Prior Zolpidem 3 Hours Prior Zopiclone Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Zolpidem 4 Hours Prior Zolpidem 3 Hours Prior Zopiclone Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/40 (0.00%)      0/40 (0.00%)      0/40 (0.00%)      0/40 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Zolpidem 4 Hours Prior Zolpidem 3 Hours Prior Zopiclone Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/40 (12.50%)      5/40 (12.50%)      6/40 (15.00%)      4/40 (10.00%)    
Eye disorders         
Eye inflammation  1  0/40 (0.00%)  0 0/40 (0.00%)  0 0/40 (0.00%)  0 1/40 (2.50%)  1
Gastrointestinal disorders         
Diarrhoea  1  0/40 (0.00%)  0 0/40 (0.00%)  0 1/40 (2.50%)  1 0/40 (0.00%)  0
Nausea  1  1/40 (2.50%)  1 0/40 (0.00%)  0 1/40 (2.50%)  1 0/40 (0.00%)  0
Vomiting  1  0/40 (0.00%)  0 0/40 (0.00%)  0 1/40 (2.50%)  1 0/40 (0.00%)  0
General disorders         
Fatigue  1  0/40 (0.00%)  0 0/40 (0.00%)  0 0/40 (0.00%)  0 2/40 (5.00%)  2
Musculoskeletal and connective tissue disorders         
Myalgia  1  1/40 (2.50%)  1 0/40 (0.00%)  0 0/40 (0.00%)  0 0/40 (0.00%)  0
Nervous system disorders         
Headache  1  0/40 (0.00%)  0 3/40 (7.50%)  3 1/40 (2.50%)  1 1/40 (2.50%)  1
Somnolence  1  2/40 (5.00%)  2 2/40 (5.00%)  2 2/40 (5.00%)  2 1/40 (2.50%)  1
Reproductive system and breast disorders         
Dysmenorrhoea  1  1/40 (2.50%)  1 0/40 (0.00%)  0 1/40 (2.50%)  1 0/40 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (13.0)
No studies directly connect SDLP thresholds with an increased risk of an accident for an individual. Nor has a SDLP threshold been adopted by a regulatory body. Based on published literature, an SDLP change of 2.5 cm was used in the primary outcome.
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.
Sponsor agrees to review manuscripts within a reasonable period of time. If sponsor determines the publication included patentable subject matter, sponsor will be granted no less than 120 days to prepare patent applications.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Leader
Organization: Purdue Pharma LP
Phone: 800-733-1333
Layout table for additonal information
Responsible Party: Transcept Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01106859     History of Changes
Other Study ID Numbers: ZI-18
2010-019959-22 ( EudraCT Number )
First Submitted: April 16, 2010
First Posted: April 20, 2010
Results First Submitted: December 15, 2011
Results First Posted: January 20, 2012
Last Update Posted: February 14, 2012