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Primary objective:
To assess the efficacy of Levopront® in comparison with Libexin® based on daytime cough resolution rate by Day 8.
The daytime cough symptoms resolution corresponds to 0 or 1 points on the "Six-point daytime and nighttime cough assessment scale".
Secondary objectives:
Treatment effect assessment in terms of the following efficacy and safety parameters:
This is a multicenter, open-label, randomized, clinical trial to assess the efficacy and safety of Levopront® syrup 30 mg/5 ml in comparison with Libexin® 100 mg tablets in patients suffering from dry non-productive cough caused by acute upper respiratory infection
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Levopront® syrup 30 mg/5 ml | Experimental | 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. |
|
| Libexin® 100 mg tablets | Active Comparator | Libexin® (prenoxdiazine) 100 mg tablets. Libexin® was administered orally, 1 tablet (100 mg) 3 times a day for 7 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levopront® syrup 30 mg/5 ml | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Daytime Cough Resolution Rate by Day 8 in the PP Population | 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. | At Visit 3, Day 8 |
| Number of Participants With Daytime Cough Resolution Rate by Day 8 in the ITT Population | 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. | At Visit 3, Day 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Nighttime Cough Resolution Rate by Day 8 in the ITT Population | 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. |
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Inclusion Criteria:
Subjects should meet the following inclusion criteria to be included into this clinical trial:
Signed Informed Consent Form
Male or female aged from 18 to 65 (inclusive)
Dry non-productive cough as a symptom of acute upper respiratory infection (IDC codes J00-J06)
Daytime cough symptom score ≥ 3 points according to the "Six-point daytime and nighttime cough assessment scale"
Pre-bronchodilator FEV1 ≥ 70% of the predicted values, post-bronchodilator FEV1 increase of ≤ 12% or ≤ 200 ml compared to the baseline, FEV1/FVC (Tiffeneau index) ≥ 0.7
Patient's consent to follow the protocol procedures, including the completion of the patient's diary
Patient's consent to use the adequate contraception methods throughout the study period. The adequate birth control methods are as follows:
Exclusion Criteria:
Subjects with any of the following conditions will be excluded from the study:
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| Name | Affiliation | Role |
|---|---|---|
| Federico Saibene, MD | Dompé SpA Milan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| State Public Healthcare Institution of Moscow "City Clinical Hospital # 71 of Moscow Healthcare Department" | Moscow | 121374 | Russia | |||
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
ITT population consisted of all randomized patients from both treatment groups.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Daytime Cough Resolution Rate by Day 8 in the PP Population | 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. | Per-Protocol population included all randomized patients completing treatment with the study drug, having primary efficacy analysis assessment done and considered to be compliant. | Posted | Count of Participants | Participants | At Visit 3, Day 8 |
|
At visits 1 (day 1), 2 (day 4), 3 (Day 8) and follow-up (telephon call), up to day 10
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry mouth | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mauro P Ferrari, Pharm D | Dompé Farmaceutici SpA | +39 02 583831 | clinical.trials@dompe.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 14, 2017 | Sep 13, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 5, 2018 | Sep 5, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003371 | Cough |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| C035916 | dipropizine |
| C008277 | libexin |
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It is an open-label clinical trial
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|
| Libexin® | Drug | 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. |
|
|
| At Visit 3, Day 8 |
| Number of Participants With Daytime & Nighttime Cough Symptoms Resolution in the ITT Population | 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. | At Visit 2, Day 4 |
| 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 ( >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. | Baseline, At visit 2 Day 4; at visit 3, Day 8 |
| Change From Baseline in Cough Intensity According to the Visual-analogue Scale (VAS) in the ITT Population. | 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. | Baseline, At visit 2 (Day 4); at visit 3 (Day 8) |
| Change From Baseline in Pre-bronchodilator FEV1 Values on Day 8 in the ITT Population. | FEV1 is the Forced Expiratory Volume (in liters) in 1 second. The higher the value, the better the outcome. | At Visit 3 (Day 8) |
| Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) of the Various Severity According to Subjective Complaints | 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:
| 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" |
| The Laboratory of Pulmonology, State Budgetary Educational Institution of Higher Professional Education "Moscow State Medical-Stomatological University n.a. A.I. Evdokimov" under Ministry of Health of the Russian Federation (Clinical base of state budget |
| Moscow |
| 127473 |
| Russia |
| State Budgetary Educational Institution of Higher Professional Education "Ryazan' State Medical University n.a. academician I.P. Pavlov" under Ministry of Health of the Russian Federation | Ryazan | 390026 | Russia |
| "Institute of Medical Research" LLC | Saint Petersburg | 196084 | Russia |
| Saint-Petersburg State Healthcare Institution "Nikolaevskaya Hospital" | Saint Petersburg | 198510 | Russia |
| State Healthcare Institution "Regional Clinical Hospital" | Saratov | 410053 | Russia |
| LLC Treatment-and-prophylactic institution on the "Smolensk clinic" | Smolensk | 214016 | Russia |
| State Autonomous Healthcare Institution of Yaroslavl Region "Clinical Hospital of Emergency care n.a. N.V. Solovyev" | Yaroslavl | 150003 | Russia |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | 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). |
| OG001 | 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. |
|
|
|
| Primary | Number of Participants With Daytime Cough Resolution Rate by Day 8 in the ITT Population | 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. | ITT population: the population of patients based on the initial treatment assignment and not on the treatment eventually received. | Posted | Count of Participants | Participants | At Visit 3, Day 8 |
|
|
|
|
| Secondary | Number of Participants With Nighttime Cough Resolution Rate by Day 8 in the ITT Population | 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. | ITT population: the population of patients based on the initial treatment assignment and not on the treatment eventually received. | Posted | Count of Participants | Participants | At Visit 3, Day 8 |
|
|
|
|
| Secondary | Number of Participants With Daytime & Nighttime Cough Symptoms Resolution in the ITT Population | 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. | ITT population: the population of patients based on the initial treatment assignment and not on the treatment eventually received. | Posted | Count of Participants | Participants | At Visit 2, Day 4 |
|
|
|
|
| Secondary | 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 ( >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. | ITT population: the population of patients is based on the initial treatment assignment and not on the treatment eventually received. | Posted | Mean | Standard Deviation | units on a scale | Baseline, At visit 2 Day 4; at visit 3, Day 8 |
|
|
|
|
| Secondary | Change From Baseline in Cough Intensity According to the Visual-analogue Scale (VAS) in the ITT Population. | 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. | ITT population: the population of patients is based on the initial treatment assignment and not on the treatment eventually received. | Posted | Mean | Standard Deviation | units on a scale | Baseline, At visit 2 (Day 4); at visit 3 (Day 8) |
|
|
|
|
| Secondary | Change From Baseline in Pre-bronchodilator FEV1 Values on Day 8 in the ITT Population. | FEV1 is the Forced Expiratory Volume (in liters) in 1 second. The higher the value, the better the outcome. | ITT population: the population of patients is based on the initial treatment assignment and not on the treatment eventually received. | Posted | Mean | Standard Deviation | liters | At Visit 3 (Day 8) |
|
|
|
|
| Secondary | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) of the Various Severity According to Subjective Complaints | 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:
| Safety population: all patients who received at least one dose of the study drug will be included into the safety population. | Posted | Count of Participants | Participants | 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" |
|
|
|
| 0 |
| 92 |
| 0 |
| 92 |
| 14 |
| 92 |
| EG001 | 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. | 0 | 92 | 0 | 92 | 12 | 92 |
| Hypoaesthesia oral | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Gastroduodenitis | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 20.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 20.0 | Systematic Assessment |
|
| Aspartate aminitransferase increased | Investigations | MedDRA 20.0 | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 20.0 | Systematic Assessment |
|
| Sleep disorders | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
|
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| D013568 | Pathological Conditions, Signs and Symptoms |
| nighttime cough score at Visit 2, Day 4 |
|
| nighttime cough score at Visit 3, Day 8 |
|
Daytime at Visit 3, Day 8 |
| t-test, 2 sided |
Between groups change was tested using two sample t-test (normal data) or Mann-Whitney test (violation of normality). |
| <0.001 |
| Non-Inferiority |
non-inferiority margin was defined as 20% |
| Nightime at Visit 2, Day 4 | t-test, 1 sided | Between groups change was tested using two sample t-test (normal data) or Mann-Whitney test (violation of normality). | <0.001 | Non-Inferiority | non-inferiority margin was defined as 20% |
| Nighttime at Visit 3, Day 8 | t-test, 1 sided | Between groups change was tested using two sample t-test (normal data) or Mann-Whitney test (violation of normality). | <0.001 | Non-Inferiority | non-inferiority margin was defined as 20% |
at Visit 3, Day 8 |
| t-test, 1 sided |
Between groups change was tested using two sample t-test (normal data) or Mann-Whitney test (violation of normality). |
| <0.001 |
| Non-Inferiority |
non-inferiority margin was defined as 20% |
| Patients with death outcome AE/SAE |
|
| Patients with mild and moderate AE/SAE |
|
| Patients with severe AE/SAE |
|
| Patients with related (possible, probable or highly probable) AE/SAE |
|
| Patients with AE/SAE led to discontinuation |
|