Trial Outcomes & Findings for Clinical Trial of Efficacy and Safety of Levopront® 30 mg/5 ml in Patients With Dry Cough (NCT NCT03837938)

Last Updated: 2024-04-16

Results Overview

Daytime cough (\>08:00h up to 22:00 h) was evaluated on a 6-point scale (Six-point daytime and nighttime cough assessment scale") where 0 = no cough during the day; and 5 = distressing cough most of the day. The daytime cough symptoms resolution corresponds to 0 or 1 points on the 6-point scale. The lower the score the better the outcome. The rate of patients who responded to treatment (cough absents, when score is 0 or 1 at "six-point cough scale" vs. cough presents, when score is ≥ 2 at "six-point cough score") by Day 8 in the study treatment group and in the control group with a non-inferiority margin of δ = 20% is reported.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

184 participants

Primary outcome timeframe

At Visit 3, Day 8

Results posted on

2024-04-16

Participant Flow

Totally, 184 patients were randomized into Levopront® (Test) and the Libexin® (Control) treatment groups: there were 92 patients in each group. All the patients completed the study according to the protocol. One patient was screen failure due to post-bronchodilator FEV1 increase.

Participant milestones

Participant milestones
Measure	Levopront® Syrup 30 mg/5 ml Levopront® (levodropropizine) syrup 30 mg/5 ml 10 ml (60 mg) t.i.d. for 7 days. The study drugs was taken 3 times a day, at intervals of at least 6 hours, between meals for 7 days. Levopront® syrup 30 mg/5 ml: The first study drug administration was performed at the clinical site on the day of randomization; the last study drug administration was performed in the evening before Day 8 (±1).	Libexin® 100 mg Tablets Libexin® (prenoxdiazine) 100 mg tablets. Libexin® was administered orally, 1 tablet (100 mg) 3 times a day for 7 days. Libexin®: The first study drug administration was performed at the clinical site on the day of randomization; the last study drug administration was performed in the evening before Day 8 (±1). No chewing.
Overall Study STARTED	92	92
Overall Study ITT Population	92	92
Overall Study PP Population	88	91
Overall Study Safety Population	92	92
Overall Study COMPLETED	92	92
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Trial of Efficacy and Safety of Levopront® 30 mg/5 ml in Patients With Dry Cough

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Levopront® Syrup 30 mg/5 ml n=92 Participants Levopront® (levodropropizine) syrup 30 mg/5 ml 10 ml (60 mg) t.i.d. for 7 days. The study drugs was taken 3 times a day, at intervals of at least 6 hours, between meals for 7 days. Levopront® syrup 30 mg/5 ml: The first study drug administration was performed at the clinical site on the day of randomization; the last study drug administration was performed in the evening before Day 8 (±1).	Libexin® 100 mg Tablets n=92 Participants Libexin® (prenoxdiazine) 100 mg tablets. Libexin® was administered orally, 1 tablet (100 mg) 3 times a day for 7 days. Libexin®: The first study drug administration was performed at the clinical site on the day of randomization; the last study drug administration was performed in the evening before Day 8 (±1). No chewing.	Total n=184 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	92 Participants n=5 Participants	92 Participants n=7 Participants	184 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	40.2 years STANDARD_DEVIATION 11.4 • n=5 Participants	40.2 years STANDARD_DEVIATION 13.4 • n=7 Participants	40.2 years STANDARD_DEVIATION 12.42 • n=5 Participants
Sex: Female, Male Female	60 Participants n=5 Participants	64 Participants n=7 Participants	124 Participants n=5 Participants
Sex: Female, Male Male	32 Participants n=5 Participants	28 Participants n=7 Participants	60 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	92 Participants n=5 Participants	92 Participants n=7 Participants	184 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Russia	92 participants n=5 Participants	92 participants n=7 Participants	184 participants n=5 Participants

PRIMARY outcome

Timeframe: At Visit 3, Day 8

Population: Per-Protocol population included all randomized patients completing treatment with the study drug, having primary efficacy analysis assessment done and considered to be compliant.

Outcome measures

Outcome measures
Measure	Levopront® Syrup 30 mg/5 ml n=88 Participants Levopront® (levodropropizine) syrup 30 mg/5 ml 10 ml (60 mg) t.i.d. for 7 days. The study drugs was taken 3 times a day, at intervals of at least 6 hours, between meals for 7 days. Levopront® syrup 30 mg/5 ml: The first study drug administration was performed at the clinical site on the day of randomization; the last study drug administration was performed in the evening before Day 8 (±1).	Libexin® 100 mg Tablets n=91 Participants Libexin® (prenoxdiazine) 100 mg tablets. Libexin® was administered orally, 1 tablet (100 mg) 3 times a day for 7 days. Libexin®: The first study drug administration was performed at the clinical site on the day of randomization; the last study drug administration was performed in the evening before Day 8 (±1). No chewing.
Number of Participants With Daytime Cough Resolution Rate by Day 8 in the PP Population Resolved (<2)	67 Participants	64 Participants
Number of Participants With Daytime Cough Resolution Rate by Day 8 in the PP Population Ongoing (≥2)	21 Participants	27 Participants

PRIMARY outcome

Timeframe: At Visit 3, Day 8

Population: ITT population: the population of patients based on the initial treatment assignment and not on the treatment eventually received.

Outcome measures

Outcome measures
Measure	Levopront® Syrup 30 mg/5 ml n=92 Participants Levopront® (levodropropizine) syrup 30 mg/5 ml 10 ml (60 mg) t.i.d. for 7 days. The study drugs was taken 3 times a day, at intervals of at least 6 hours, between meals for 7 days. Levopront® syrup 30 mg/5 ml: The first study drug administration was performed at the clinical site on the day of randomization; the last study drug administration was performed in the evening before Day 8 (±1).	Libexin® 100 mg Tablets n=92 Participants Libexin® (prenoxdiazine) 100 mg tablets. Libexin® was administered orally, 1 tablet (100 mg) 3 times a day for 7 days. Libexin®: The first study drug administration was performed at the clinical site on the day of randomization; the last study drug administration was performed in the evening before Day 8 (±1). No chewing.
Number of Participants With Daytime Cough Resolution Rate by Day 8 in the ITT Population Resolved (<2)	70 Participants	65 Participants
Number of Participants With Daytime Cough Resolution Rate by Day 8 in the ITT Population Ongoing (≥2)	22 Participants	27 Participants

SECONDARY outcome

Timeframe: At Visit 3, Day 8

Population: ITT population: the population of patients based on the initial treatment assignment and not on the treatment eventually received.

Night-time cough ( \>22:00 h up to 08:00 h) was evaluated on a 6-point scale (Six-point daytime and nighttime cough assessment scale") where 0 = no cough during the night to 5 = distressing coughs preventing any sleep. The nighttime cough symptoms resolution corresponds to 0 or 1 points on the 6-point scale. The lower the score the better the outcome. The rate of patients who responded to treatment (cough absents, when score is 0 or 1 at "six-point cough scale" vs. cough presents, when score is ≥ 2 at "six-point cough score") by Day 8 in the study treatment group and in the control group with a non-inferiority margin of δ = 20% is reported.

Outcome measures

Outcome measures
Measure	Levopront® Syrup 30 mg/5 ml n=92 Participants Levopront® (levodropropizine) syrup 30 mg/5 ml 10 ml (60 mg) t.i.d. for 7 days. The study drugs was taken 3 times a day, at intervals of at least 6 hours, between meals for 7 days. Levopront® syrup 30 mg/5 ml: The first study drug administration was performed at the clinical site on the day of randomization; the last study drug administration was performed in the evening before Day 8 (±1).	Libexin® 100 mg Tablets n=92 Participants Libexin® (prenoxdiazine) 100 mg tablets. Libexin® was administered orally, 1 tablet (100 mg) 3 times a day for 7 days. Libexin®: The first study drug administration was performed at the clinical site on the day of randomization; the last study drug administration was performed in the evening before Day 8 (±1). No chewing.
Number of Participants With Nighttime Cough Resolution Rate by Day 8 in the ITT Population Resolved (<2)	90 Participants	89 Participants
Number of Participants With Nighttime Cough Resolution Rate by Day 8 in the ITT Population Ongoing (≥2)	2 Participants	3 Participants

SECONDARY outcome

Timeframe: At Visit 2, Day 4

Population: ITT population: the population of patients based on the initial treatment assignment and not on the treatment eventually received.

Daytime cough ( \>08:00h up to 22:00 h) was evaluated on a 6-point scale (Six-point daytime and nighttime cough assessment scale) where 0 = no cough during the day to 5 = distressing coughs most of the day. Night-time cough ( \>22:00 h up to 08:00 h) was evaluated on a 6-point scale (Six-point daytime and nighttime cough assessment scale) where 0 = no cough during the night to 5 = distressing coughs preventing any sleep. The (daytime and nighttime) cough symptoms resolution corresponds to 0 or 1 points on the 6-point scale. The lower the score the better the outcome. The rate of patients who responded to treatment (cough absents, when score is 0 or 1 at "six-point cough scale" vs. cough presents, when score is ≥ 2 at "six-point cough score") by Day 4 in the study treatment group and in the control group with a non-inferiority margin of δ = 20% is reported.

Outcome measures

Outcome measures
Measure	Levopront® Syrup 30 mg/5 ml n=92 Participants Levopront® (levodropropizine) syrup 30 mg/5 ml 10 ml (60 mg) t.i.d. for 7 days. The study drugs was taken 3 times a day, at intervals of at least 6 hours, between meals for 7 days. Levopront® syrup 30 mg/5 ml: The first study drug administration was performed at the clinical site on the day of randomization; the last study drug administration was performed in the evening before Day 8 (±1).	Libexin® 100 mg Tablets n=92 Participants Libexin® (prenoxdiazine) 100 mg tablets. Libexin® was administered orally, 1 tablet (100 mg) 3 times a day for 7 days. Libexin®: The first study drug administration was performed at the clinical site on the day of randomization; the last study drug administration was performed in the evening before Day 8 (±1). No chewing.
Number of Participants With Daytime & Nighttime Cough Symptoms Resolution in the ITT Population Resolved (<2)	22 Participants	20 Participants
Number of Participants With Daytime & Nighttime Cough Symptoms Resolution in the ITT Population Ongoing (≥2)	70 Participants	72 Participants

SECONDARY outcome

Timeframe: Baseline, At visit 2 Day 4; at visit 3, Day 8

Population: ITT population: the population of patients is based on the initial treatment assignment and not on the treatment eventually received.

Daytime cough ( \>08:00 h up to 22:00 h) evaluated on a 6-point scale: 0 = no cough during the day to 5 = distressing coughs most of the day. Night-time cough ( \>22:00 h up to 08:00 h) evaluated on a 6-point scale: 0 = no cough during the night to 5 = distressing coughs preventing any sleep.

Outcome measures

Outcome measures
Measure	Levopront® Syrup 30 mg/5 ml n=92 Participants Levopront® (levodropropizine) syrup 30 mg/5 ml 10 ml (60 mg) t.i.d. for 7 days. The study drugs was taken 3 times a day, at intervals of at least 6 hours, between meals for 7 days. Levopront® syrup 30 mg/5 ml: The first study drug administration was performed at the clinical site on the day of randomization; the last study drug administration was performed in the evening before Day 8 (±1).	Libexin® 100 mg Tablets n=92 Participants Libexin® (prenoxdiazine) 100 mg tablets. Libexin® was administered orally, 1 tablet (100 mg) 3 times a day for 7 days. Libexin®: The first study drug administration was performed at the clinical site on the day of randomization; the last study drug administration was performed in the evening before Day 8 (±1). No chewing.
Change From Baseline in Severity and Frequency of Daytime and Nighttime Cough According to "Six-point Daytime and Nighttime Cough Assessment Scale" in the ITT Population daytime cough score at Visit 2, Day 4	-1.2 units on a scale Standard Deviation 0.8	-1.2 units on a scale Standard Deviation 0.6
Change From Baseline in Severity and Frequency of Daytime and Nighttime Cough According to "Six-point Daytime and Nighttime Cough Assessment Scale" in the ITT Population daytime cough score at Visit 3, Day 8	-2.5 units on a scale Standard Deviation 0.8	-2.2 units on a scale Standard Deviation 0.7
Change From Baseline in Severity and Frequency of Daytime and Nighttime Cough According to "Six-point Daytime and Nighttime Cough Assessment Scale" in the ITT Population nighttime cough score at Visit 2, Day 4	-0.9 units on a scale Standard Deviation 0.8	-1.0 units on a scale Standard Deviation 0.9
Change From Baseline in Severity and Frequency of Daytime and Nighttime Cough According to "Six-point Daytime and Nighttime Cough Assessment Scale" in the ITT Population nighttime cough score at Visit 3, Day 8	-1.9 units on a scale Standard Deviation 1.1	-1.9 units on a scale Standard Deviation 1.0

SECONDARY outcome

Timeframe: Baseline, At visit 2 (Day 4); at visit 3 (Day 8)

Population: ITT population: the population of patients is based on the initial treatment assignment and not on the treatment eventually received.

The visual-analogue scale (VAS) is a 100 mm scale which ranges from 'no cough' (0 mm) to 'the worst cough severity' (100 mm). The higher the score, the worse the outcome.

Outcome measures

Outcome measures
Measure	Levopront® Syrup 30 mg/5 ml n=92 Participants Levopront® (levodropropizine) syrup 30 mg/5 ml 10 ml (60 mg) t.i.d. for 7 days. The study drugs was taken 3 times a day, at intervals of at least 6 hours, between meals for 7 days. Levopront® syrup 30 mg/5 ml: The first study drug administration was performed at the clinical site on the day of randomization; the last study drug administration was performed in the evening before Day 8 (±1).	Libexin® 100 mg Tablets n=92 Participants Libexin® (prenoxdiazine) 100 mg tablets. Libexin® was administered orally, 1 tablet (100 mg) 3 times a day for 7 days. Libexin®: The first study drug administration was performed at the clinical site on the day of randomization; the last study drug administration was performed in the evening before Day 8 (±1). No chewing.
Change From Baseline in Cough Intensity According to the Visual-analogue Scale (VAS) in the ITT Population. Visit 2, Day 4	-28.9 units on a scale Standard Deviation 15.0	-24.9 units on a scale Standard Deviation 15.0
Change From Baseline in Cough Intensity According to the Visual-analogue Scale (VAS) in the ITT Population. Visit 3, Day 8	-52.1 units on a scale Standard Deviation 18.1	-44.6 units on a scale Standard Deviation 17.8

SECONDARY outcome

Timeframe: At Visit 3 (Day 8)

Population: ITT population: the population of patients is based on the initial treatment assignment and not on the treatment eventually received.

FEV1 is the Forced Expiratory Volume (in liters) in 1 second. The higher the value, the better the outcome.

Outcome measures

Outcome measures
Measure	Levopront® Syrup 30 mg/5 ml n=92 Participants Levopront® (levodropropizine) syrup 30 mg/5 ml 10 ml (60 mg) t.i.d. for 7 days. The study drugs was taken 3 times a day, at intervals of at least 6 hours, between meals for 7 days. Levopront® syrup 30 mg/5 ml: The first study drug administration was performed at the clinical site on the day of randomization; the last study drug administration was performed in the evening before Day 8 (±1).	Libexin® 100 mg Tablets n=92 Participants Libexin® (prenoxdiazine) 100 mg tablets. Libexin® was administered orally, 1 tablet (100 mg) 3 times a day for 7 days. Libexin®: The first study drug administration was performed at the clinical site on the day of randomization; the last study drug administration was performed in the evening before Day 8 (±1). No chewing.
Change From Baseline in Pre-bronchodilator FEV1 Values on Day 8 in the ITT Population.	0.0 liters Standard Deviation 0.6	0.1 liters Standard Deviation 0.4

SECONDARY outcome

Timeframe: From the moment of signing Informed Consent Form (prior to administration of the first dose of the study drug) to Day 30 after the last visit of the patient or last procedure per protocol, up to day 10"

Population: Safety population: all patients who received at least one dose of the study drug will be included into the safety population.

Adverse Event (AE) - any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, complaint or disorder. Serious Adverse Event (SAE) - Any adverse medical event which, irrespective of the dose of the study drug: * results in death; * is life-threatening; * requires hospitalization (initial or prolonged); * results in significant, persistent or permanent impairment or disability; or * is a congenital anomaly or birth defect * is an important medical event that may be not immediately life threatening or result in death or hospitalization but, based upon appropriate medical judgment, may jeopardize the patient and may require medical or surgical intervention to prevent one of the outcomes listed in the definition above.

Outcome measures

Outcome measures
Measure	Levopront® Syrup 30 mg/5 ml n=92 Participants Levopront® (levodropropizine) syrup 30 mg/5 ml 10 ml (60 mg) t.i.d. for 7 days. The study drugs was taken 3 times a day, at intervals of at least 6 hours, between meals for 7 days. Levopront® syrup 30 mg/5 ml: The first study drug administration was performed at the clinical site on the day of randomization; the last study drug administration was performed in the evening before Day 8 (±1).	Libexin® 100 mg Tablets n=92 Participants Libexin® (prenoxdiazine) 100 mg tablets. Libexin® was administered orally, 1 tablet (100 mg) 3 times a day for 7 days. Libexin®: The first study drug administration was performed at the clinical site on the day of randomization; the last study drug administration was performed in the evening before Day 8 (±1). No chewing.
Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) of the Various Severity According to Subjective Complaints patients with AE/SAE	14 Participants	12 Participants
Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) of the Various Severity According to Subjective Complaints patients with SAE	0 Participants	0 Participants
Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) of the Various Severity According to Subjective Complaints Patients with death outcome AE/SAE	0 Participants	0 Participants
Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) of the Various Severity According to Subjective Complaints Patients with mild and moderate AE/SAE	14 Participants	12 Participants
Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) of the Various Severity According to Subjective Complaints Patients with severe AE/SAE	0 Participants	0 Participants
Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) of the Various Severity According to Subjective Complaints Patients with related (possible, probable or highly probable) AE/SAE	1 Participants	2 Participants
Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) of the Various Severity According to Subjective Complaints Patients with AE/SAE led to discontinuation	0 Participants	0 Participants

Adverse Events

Levopront® Syrup 30 mg/5 ml

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Libexin® 100 mg Tablets

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Levopront® Syrup 30 mg/5 ml n=92 participants at risk Levopront® (levodropropizine) syrup 30 mg/5 ml 10 ml (60 mg) t.i.d. for 7 days. The study drugs was taken 3 times a day, at intervals of at least 6 hours, between meals for 7 days. Levopront® syrup 30 mg/5 ml: The first study drug administration was performed at the clinical site on the day of randomization; the last study drug administration was performed in the evening before Day 8 (±1).	Libexin® 100 mg Tablets n=92 participants at risk Libexin® (prenoxdiazine) 100 mg tablets. Libexin® was administered orally, 1 tablet (100 mg) 3 times a day for 7 days. Libexin®: The first study drug administration was performed at the clinical site on the day of randomization; the last study drug administration was performed in the evening before Day 8 (±1). No chewing.
Gastrointestinal disorders Dry mouth	2.2% 2/92 • Number of events 2 • At visits 1 (day 1), 2 (day 4), 3 (Day 8) and follow-up (telephon call), up to day 10	4.3% 4/92 • Number of events 4 • At visits 1 (day 1), 2 (day 4), 3 (Day 8) and follow-up (telephon call), up to day 10
Gastrointestinal disorders Hypoaesthesia oral	1.1% 1/92 • Number of events 1 • At visits 1 (day 1), 2 (day 4), 3 (Day 8) and follow-up (telephon call), up to day 10	0.00% 0/92 • At visits 1 (day 1), 2 (day 4), 3 (Day 8) and follow-up (telephon call), up to day 10
Gastrointestinal disorders Nausea	1.1% 1/92 • Number of events 1 • At visits 1 (day 1), 2 (day 4), 3 (Day 8) and follow-up (telephon call), up to day 10	0.00% 0/92 • At visits 1 (day 1), 2 (day 4), 3 (Day 8) and follow-up (telephon call), up to day 10
Gastrointestinal disorders Gastroduodenitis	0.00% 0/92 • At visits 1 (day 1), 2 (day 4), 3 (Day 8) and follow-up (telephon call), up to day 10	1.1% 1/92 • Number of events 2 • At visits 1 (day 1), 2 (day 4), 3 (Day 8) and follow-up (telephon call), up to day 10
Gastrointestinal disorders Abdominal pain	0.00% 0/92 • At visits 1 (day 1), 2 (day 4), 3 (Day 8) and follow-up (telephon call), up to day 10	1.1% 1/92 • Number of events 1 • At visits 1 (day 1), 2 (day 4), 3 (Day 8) and follow-up (telephon call), up to day 10
Nervous system disorders Headache	5.4% 5/92 • Number of events 5 • At visits 1 (day 1), 2 (day 4), 3 (Day 8) and follow-up (telephon call), up to day 10	4.3% 4/92 • Number of events 4 • At visits 1 (day 1), 2 (day 4), 3 (Day 8) and follow-up (telephon call), up to day 10
Nervous system disorders Dizziness	1.1% 1/92 • Number of events 1 • At visits 1 (day 1), 2 (day 4), 3 (Day 8) and follow-up (telephon call), up to day 10	0.00% 0/92 • At visits 1 (day 1), 2 (day 4), 3 (Day 8) and follow-up (telephon call), up to day 10
Nervous system disorders Dysgeusia	0.00% 0/92 • At visits 1 (day 1), 2 (day 4), 3 (Day 8) and follow-up (telephon call), up to day 10	1.1% 1/92 • Number of events 1 • At visits 1 (day 1), 2 (day 4), 3 (Day 8) and follow-up (telephon call), up to day 10
General disorders Malaise	1.1% 1/92 • Number of events 1 • At visits 1 (day 1), 2 (day 4), 3 (Day 8) and follow-up (telephon call), up to day 10	0.00% 0/92 • At visits 1 (day 1), 2 (day 4), 3 (Day 8) and follow-up (telephon call), up to day 10
Investigations Alanine aminotransferase increased	2.2% 2/92 • Number of events 2 • At visits 1 (day 1), 2 (day 4), 3 (Day 8) and follow-up (telephon call), up to day 10	1.1% 1/92 • Number of events 1 • At visits 1 (day 1), 2 (day 4), 3 (Day 8) and follow-up (telephon call), up to day 10
Investigations Aspartate aminitransferase increased	1.1% 1/92 • Number of events 1 • At visits 1 (day 1), 2 (day 4), 3 (Day 8) and follow-up (telephon call), up to day 10	0.00% 0/92 • At visits 1 (day 1), 2 (day 4), 3 (Day 8) and follow-up (telephon call), up to day 10
Renal and urinary disorders Haematuria	1.1% 1/92 • Number of events 1 • At visits 1 (day 1), 2 (day 4), 3 (Day 8) and follow-up (telephon call), up to day 10	0.00% 0/92 • At visits 1 (day 1), 2 (day 4), 3 (Day 8) and follow-up (telephon call), up to day 10
Psychiatric disorders Sleep disorders	0.00% 0/92 • At visits 1 (day 1), 2 (day 4), 3 (Day 8) and follow-up (telephon call), up to day 10	1.1% 1/92 • Number of events 1 • At visits 1 (day 1), 2 (day 4), 3 (Day 8) and follow-up (telephon call), up to day 10

Additional Information

Mauro P Ferrari, Pharm D

Dompé Farmaceutici SpA

Phone: +39 02 583831

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place