Trial Outcomes & Findings for Driving Performance After Middle of the Night Administration of 3.5 mg Zolpidem Tartrate Sublingual Tablet (NCT NCT01106859)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

40 participants

Primary outcome timeframe

3-9 hours post dose

Results posted on

2012-02-14

Participant Flow

Forty-four candidates were screened. Four screening failures: high blood pressure (2), positive drug test (1), personal reasons (1)

Participant milestones

Participant milestones
Measure	Total Population All participants in this four-way cross-over study
Overall Study STARTED	40
Overall Study COMPLETED	40
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Total Population n=40 Participants All participants in this four-way cross-over study
Age Continuous	37 years STANDARD_DEVIATION 15 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	40 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race/Ethnicity, Customized White	39 participants n=5 Participants
Race/Ethnicity, Customized Black	0 participants n=5 Participants
Race/Ethnicity, Customized Asian	0 participants n=5 Participants
Race/Ethnicity, Customized Other	1 participants n=5 Participants
Region of Enrollment Netherlands	40 participants n=5 Participants
Height	176 centimeters STANDARD_DEVIATION 9 • n=5 Participants
Weight Male	79 kilograms STANDARD_DEVIATION 8 • n=5 Participants
Weight Female	65 kilograms STANDARD_DEVIATION 8 • n=5 Participants
Body Mass Index (BMI)	23.2 kilograms/meter^2 STANDARD_DEVIATION 2.4 • n=5 Participants

PRIMARY outcome

Timeframe: 3-9 hours post dose

Population: Intent to treat population

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.

Outcome measures

Outcome measures
Measure	Zolpidem 4 Hours Prior n=40 Participants 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.	Zolpidem 3 Hours Prior n=40 Participants 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 n=40 Participants 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.	Placebo A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is a placebo matching zolpidem tartrate sublingual tablet.
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 Neutral	34 participants	29 participants	22 participants	—
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 Improved	1 participants	1 participants	0 participants	—
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 Impaired	5 participants	10 participants	18 participants	—

PRIMARY outcome

Timeframe: 3-9 hours post dose

Population: Intent to treat population

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.

Outcome measures

Outcome measures
Measure	Zolpidem 4 Hours Prior n=40 Participants 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.	Zolpidem 3 Hours Prior n=40 Participants 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 n=40 Participants 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.	Placebo n=40 Participants A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is a placebo matching zolpidem tartrate sublingual tablet.
Probability of Differences From Placebo Exceeding The 2.5 cm Threshold in Standard Deviation of Lateral Position (SDLP) Following Administration of Active Therapy Probability - impaired	0.125 proportion	0.250 proportion	0.450 proportion	NA proportion Probability for the active treatment arms uses the Placebo experience as a base case from which to calculate probability.
Probability of Differences From Placebo Exceeding The 2.5 cm Threshold in Standard Deviation of Lateral Position (SDLP) Following Administration of Active Therapy Probability - improved	0.025 proportion	0.025 proportion	0.000 proportion	NA proportion Probability for the active treatment arms uses the Placebo experience as a base case from which to calculate probability.

SECONDARY outcome

Timeframe: 3-9 hours post dose

Population: Intent to treat population

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.

Outcome measures

Outcome measures
Measure	Zolpidem 4 Hours Prior n=40 Participants 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.	Zolpidem 3 Hours Prior n=40 Participants 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 n=40 Participants 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.	Placebo n=40 Participants A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is a placebo matching zolpidem tartrate sublingual tablet.
Mean Standard Deviation of Lateral Position (SDLP) in the Highway Driving Test	16.7 centimeters Standard Error 0.60	17.3 centimeters Standard Error 0.60	18.3 centimeters Standard Error 0.60	15.9 centimeters Standard Error 0.60

SECONDARY outcome

Timeframe: 3-9 hours post dose

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Zolpidem 4 Hours Prior n=40 Participants 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.	Zolpidem 3 Hours Prior n=40 Participants 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 n=39 Participants 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.	Placebo n=40 Participants A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is a placebo matching zolpidem tartrate sublingual tablet.
Mean Standard Deviation of Speed (SDS) in the Highway Drive Test	1.98 kilometers/hour Standard Error 0.08	1.91 kilometers/hour Standard Error 0.08	1.99 kilometers/hour Standard Error 0.08	1.83 kilometers/hour Standard Error 0.08

SECONDARY outcome

Timeframe: Day 1 -6 weeks

Population: Safety population (participants who were randomized and received at least one dose of study drug)

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.

Outcome measures

Outcome measures
Measure	Zolpidem 4 Hours Prior n=40 Participants 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.	Zolpidem 3 Hours Prior n=40 Participants 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 n=40 Participants 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.	Placebo n=40 Participants A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is a placebo matching zolpidem tartrate sublingual tablet.
Summary of Participants With Treatment Emergent Adverse Experiences (TEAEs) Unrelated	3 participants	2 participants	4 participants	1 participants
Summary of Participants With Treatment Emergent Adverse Experiences (TEAEs) Discontinued study medication due to AE	0 participants	0 participants	0 participants	0 participants
Summary of Participants With Treatment Emergent Adverse Experiences (TEAEs) At least one TEAE	5 participants	5 participants	6 participants	4 participants
Summary of Participants With Treatment Emergent Adverse Experiences (TEAEs) TEAE graded as mild	4 participants	5 participants	6 participants	4 participants
Summary of Participants With Treatment Emergent Adverse Experiences (TEAEs) TEAE graded as moderate	1 participants	0 participants	0 participants	0 participants
Summary of Participants With Treatment Emergent Adverse Experiences (TEAEs) TEAE graded as severe	0 participants	0 participants	0 participants	0 participants
Summary of Participants With Treatment Emergent Adverse Experiences (TEAEs) Related	2 participants	3 participants	2 participants	3 participants
Summary of Participants With Treatment Emergent Adverse Experiences (TEAEs) At least one serious AE	0 participants	0 participants	0 participants	0 participants
Summary of Participants With Treatment Emergent Adverse Experiences (TEAEs) Death	0 participants	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: 3-9 hours post dose

Population: Intent to treat population

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.

Outcome measures

Outcome measures
Measure	Zolpidem 4 Hours Prior n=40 Participants 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.	Zolpidem 3 Hours Prior n=40 Participants 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 n=40 Participants 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.	Placebo A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is a placebo matching zolpidem tartrate sublingual tablet.
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 Impaired	6 participants	13 participants	19 participants	—
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 Neutral	33 participants	25 participants	21 participants	—
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 Improved	1 participants	2 participants	0 participants	—

SECONDARY outcome

Timeframe: 3-9 hours post dose

Population: Intent to treat population

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.

Outcome measures

Outcome measures
Measure	Zolpidem 4 Hours Prior n=40 Participants 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.	Zolpidem 3 Hours Prior n=40 Participants 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 n=40 Participants 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.	Placebo n=40 Participants A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is a placebo matching zolpidem tartrate sublingual tablet.
Probability of Differences From Placebo Exceeding The 2.0 cm Threshold in Standard Deviation of Lateral Position (SDLP) Following Administration of Active Therapy Probability - improved	0.025 proportion	0.050 proportion	0.000 proportion	NA proportion Probability for the active treatment arms uses the Placebo experience as a base case from which to calculate probability.
Probability of Differences From Placebo Exceeding The 2.0 cm Threshold in Standard Deviation of Lateral Position (SDLP) Following Administration of Active Therapy Probability - impaired	0.150 proportion	0.325 proportion	0.475 proportion	NA proportion Probability for the active treatment arms uses the Placebo experience as a base case from which to calculate probability.

SECONDARY outcome

Timeframe: 3-9 hours post dose

Population: Intent to treat population

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.

Outcome measures

Outcome measures
Measure	Zolpidem 4 Hours Prior n=40 Participants 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.	Zolpidem 3 Hours Prior n=40 Participants 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 n=40 Participants 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.	Placebo A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is a placebo matching zolpidem tartrate sublingual tablet.
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 Improved	0 participants	0 participants	0 participants	—
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 Impaired	2 participants	7 participants	14 participants	—
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 Neutral	38 participants	33 participants	26 participants	—

SECONDARY outcome

Timeframe: 3-9 hours post dose

Population: Intent to treat population

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.

Outcome measures

Outcome measures
Measure	Zolpidem 4 Hours Prior n=40 Participants 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.	Zolpidem 3 Hours Prior n=40 Participants 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 n=40 Participants 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.	Placebo n=40 Participants A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is a placebo matching zolpidem tartrate sublingual tablet.
Probability of Differences From Placebo Exceeding The 3.5 cm Threshold in Standard Deviation of Lateral Position (SDLP) Following Administration of Active Therapy Probability - improved	0.000 proportion	0.000 proportion	0.000 proportion	NA proportion Probability for the active treatment arms uses the Placebo experience as a base case from which to calculate probability.
Probability of Differences From Placebo Exceeding The 3.5 cm Threshold in Standard Deviation of Lateral Position (SDLP) Following Administration of Active Therapy Probability - impaired	0.050 proportion	0.175 proportion	0.350 proportion	NA proportion Probability for the active treatment arms uses the Placebo experience as a base case from which to calculate probability.

Adverse Events

Zolpidem 4 Hours Prior

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Zolpidem 3 Hours Prior

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Zopiclone

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Zolpidem 4 Hours Prior n=40 participants at risk 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.	Zolpidem 3 Hours Prior n=40 participants at risk 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 n=40 participants at risk 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.	Placebo n=40 participants at risk A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is a placebo matching zolpidem tartrate sublingual tablet.
Eye disorders Eye inflammation	0.00% 0/40 • Treatment emergent AEs (Day 1 to Week 6)	0.00% 0/40 • Treatment emergent AEs (Day 1 to Week 6)	0.00% 0/40 • Treatment emergent AEs (Day 1 to Week 6)	2.5% 1/40 • Number of events 1 • Treatment emergent AEs (Day 1 to Week 6)
Gastrointestinal disorders Diarrhoea	0.00% 0/40 • Treatment emergent AEs (Day 1 to Week 6)	0.00% 0/40 • Treatment emergent AEs (Day 1 to Week 6)	2.5% 1/40 • Number of events 1 • Treatment emergent AEs (Day 1 to Week 6)	0.00% 0/40 • Treatment emergent AEs (Day 1 to Week 6)
Gastrointestinal disorders Nausea	2.5% 1/40 • Number of events 1 • Treatment emergent AEs (Day 1 to Week 6)	0.00% 0/40 • Treatment emergent AEs (Day 1 to Week 6)	2.5% 1/40 • Number of events 1 • Treatment emergent AEs (Day 1 to Week 6)	0.00% 0/40 • Treatment emergent AEs (Day 1 to Week 6)
Gastrointestinal disorders Vomiting	0.00% 0/40 • Treatment emergent AEs (Day 1 to Week 6)	0.00% 0/40 • Treatment emergent AEs (Day 1 to Week 6)	2.5% 1/40 • Number of events 1 • Treatment emergent AEs (Day 1 to Week 6)	0.00% 0/40 • Treatment emergent AEs (Day 1 to Week 6)
General disorders Fatigue	0.00% 0/40 • Treatment emergent AEs (Day 1 to Week 6)	0.00% 0/40 • Treatment emergent AEs (Day 1 to Week 6)	0.00% 0/40 • Treatment emergent AEs (Day 1 to Week 6)	5.0% 2/40 • Number of events 2 • Treatment emergent AEs (Day 1 to Week 6)
Musculoskeletal and connective tissue disorders Myalgia	2.5% 1/40 • Number of events 1 • Treatment emergent AEs (Day 1 to Week 6)	0.00% 0/40 • Treatment emergent AEs (Day 1 to Week 6)	0.00% 0/40 • Treatment emergent AEs (Day 1 to Week 6)	0.00% 0/40 • Treatment emergent AEs (Day 1 to Week 6)
Nervous system disorders Headache	0.00% 0/40 • Treatment emergent AEs (Day 1 to Week 6)	7.5% 3/40 • Number of events 3 • Treatment emergent AEs (Day 1 to Week 6)	2.5% 1/40 • Number of events 1 • Treatment emergent AEs (Day 1 to Week 6)	2.5% 1/40 • Number of events 1 • Treatment emergent AEs (Day 1 to Week 6)
Nervous system disorders Somnolence	5.0% 2/40 • Number of events 2 • Treatment emergent AEs (Day 1 to Week 6)	5.0% 2/40 • Number of events 2 • Treatment emergent AEs (Day 1 to Week 6)	5.0% 2/40 • Number of events 2 • Treatment emergent AEs (Day 1 to Week 6)	2.5% 1/40 • Number of events 1 • Treatment emergent AEs (Day 1 to Week 6)
Reproductive system and breast disorders Dysmenorrhoea	2.5% 1/40 • Number of events 1 • Treatment emergent AEs (Day 1 to Week 6)	0.00% 0/40 • Treatment emergent AEs (Day 1 to Week 6)	2.5% 1/40 • Number of events 1 • Treatment emergent AEs (Day 1 to Week 6)	0.00% 0/40 • Treatment emergent AEs (Day 1 to Week 6)

Additional Information

Clinical Leader

Purdue Pharma LP

Phone: 800-733-1333

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER