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The aim of this trial is to investigate the efficacy and tolerance of Ambroxol lozenges 20 mg in the treatment of sore throat in patients with acute viral pharyngitis.
Male and female ambulant patients complaining of a sore throat caused by acute viral pharyngitis. Every patient may be included in the trial only once. A total of 250 male and female ambulant patients between the ages of 18 and 65 years will be enrolled. Approximately 8 centers will be recruited each enrolling approximately 30-32 patients.
Study Hypothesis:
The two-sided test hypothesis, that the results of the active treatment group with 20 mg Ambroxol and the placebo group do not differ with regard to the primary endpoint (null hypothesis (H0) will be tested against the alternative (H1) that they are not equal.
Comparison(s):
PRIMARY ENDPOINT:
Indication of pain on the VRS (PI)-verbal rating scale (pain intensity)-in the first 3 hours (the patient rates his/her pain on a six-point verbal rating scale).
SECONDARY ENDPOINT (S):
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Placebo Comparator |
| |
| Ambroxol | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ambroxol | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Sum of Pain Intensity Difference (SPIDnorm)-Time-weighted Average of the Pain Intensity Difference (PID) From Pre-dose Baseline Over the First 3 Hours After the First Lozenge Expressed as a Ratio of the Pre-dose Baseline | The calculation will be based on the pain intensity (PI) assessment by the patient before and then at (pain intensity difference at 30 minutes (PID30)), (pain intensity difference at 60 minutes (PID60)), (pain intensity difference at 120 minutes (PID120)) and (pain intensity difference at 180 minutes (PID180)) after the 1st lozenge. Using the difference in PI from pre-dose baseline for each time point subsequent to dosing, the SPIDnorm will be calculated as SPIDnorm = (30*PID30 + 30*PID60 + 60*PID120 + 60*PID180)/(180*PI (baseline)) The patient rates the intensity of his sore throat pain on a 6-point Verbal Rating Scale (VRS) pain intensity (PI) before taking the first lozenge and 30, 60, 120 and 180 minutes thereafter, and enters his rating in his patient's diary . The rating scale is as follows: 0=no pain; 1=hardly any pain; 2=slight pain; 3=moderate pain; 4=severe pain; 5=very severe pain. | pre-dose baseline and 30, 60, 120, and 180 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Intensity (PI) as Rated on a 6-point VRS by the Patient at 0.5, 1, 2 and 3 Hours After the First Lozenge | Pain intensity (PI) as rated on a 6-point Verbal Rating Scale (VRS) by the patient at 0.5, 1, 2 and 3 hours after the first lozenge. The patient rates the intensity of his sore throat condition on a 6-point rating scale [VRS(PI)-verbal rating scale (pain intensity)] before taking the first lozenge and 30, 60, 120 and 180 minutes thereafter, and enters his rating in his patient's diary . The rating scale is as follows: 0=no pain; 1=hardly any pain; 2=slight pain; 3=moderate pain; 4=severe pain; 5=very severe pain. Adjusted Mean (Standard Error) are presented for this outcome measure. |
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1. Patients having a sore throat with acute viral pharyngitis. 2. Female and male ambulant patients between the ages of 18 and 65. 3. The throat pain intensity is rated at least severe on the VRS (PI). 4. Written Informed Consent is given by the patient. 5. Compliance by the patient seems guaranteed.
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim Study Coordinator | Boehringer Ingelheim Shanghai | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boehringer Ingelheim Investigational Site | Nanjing | China | ||||
| Boehringer Ingelheim Investigational Site |
Double-blind, randomized, placebo-controlled parallel design in comparison of two arms
Male or female outpatients, 18 to 65 years of age, suffering from acute viral pharyngitis and throat pain of at least severe intensity were to enter the trial.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ambroxol Lozenges 20 mg | Patients were orally administered Ambroxol lozenges 20 milligram (mg) initially (first lozenges); up to 6 lozenges per day up to two days, maximal dose:120 mg per day |
| FG001 | Placebo | Patients were orally administered Placebo matching Ambroxol lozenges 20 mg initially (first lozenges); up to 6 lozenges per day up to two days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Full Analysis Set (FAS): FAS, which included all patients
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| ID | Title | Description |
|---|---|---|
| BG000 | Ambroxol Lozenges 20 mg | Patients were orally administered Ambroxol lozenges 20 milligram (mg) initially (first lozenges); up to 6 lozenges per day up to two days, maximal dose:120 mg per day |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Sum of Pain Intensity Difference (SPIDnorm)-Time-weighted Average of the Pain Intensity Difference (PID) From Pre-dose Baseline Over the First 3 Hours After the First Lozenge Expressed as a Ratio of the Pre-dose Baseline | The calculation will be based on the pain intensity (PI) assessment by the patient before and then at (pain intensity difference at 30 minutes (PID30)), (pain intensity difference at 60 minutes (PID60)), (pain intensity difference at 120 minutes (PID120)) and (pain intensity difference at 180 minutes (PID180)) after the 1st lozenge. Using the difference in PI from pre-dose baseline for each time point subsequent to dosing, the SPIDnorm will be calculated as SPIDnorm = (30*PID30 + 30*PID60 + 60*PID120 + 60*PID180)/(180*PI (baseline)) The patient rates the intensity of his sore throat pain on a 6-point Verbal Rating Scale (VRS) pain intensity (PI) before taking the first lozenge and 30, 60, 120 and 180 minutes thereafter, and enters his rating in his patient's diary . The rating scale is as follows: 0=no pain; 1=hardly any pain; 2=slight pain; 3=moderate pain; 4=severe pain; 5=very severe pain. | Full Analysis Set (FAS): FAS, which included all patients
| Posted | Least Squares Mean | Standard Error | ratio | pre-dose baseline and 30, 60, 120, and 180 minutes |
From drug administration until end of the treatment, up to 2 days.
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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 | Ambroxol Lozenges 20 mg | Patients were orally administered Ambroxol lozenges 20 milligram (mg) initially (first lozenges); up to 6 lozenges per day up to two days, maximal dose:120 mg per day |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
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| ID | Term |
|---|---|
| D010612 | Pharyngitis |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D000551 | Ambroxol |
| ID | Term |
|---|---|
| D001964 | Bromhexine |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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|
| 0.5, 1, 2 and 3 hours |
| Pain Intensity Difference From Pre-dose Baseline (PID) as Rated on a 6-point Verbal Rating Scale (VRS) by the Patient at 0.5, 1, 2 and 3 Hours After the First Lozenge | Pain intensity difference from pre-dose baseline (PID) as rated on a 6-point Verbal Rating Scale (VRS) by the patient at 0.5, 1, 2 and 3 hours after the first lozenge. Adjusted Mean (Standard Error) are presented for this outcome measure. | pre-dose baseline and 0.5, 1, 2 and 3 hours |
| Assessment of Redness of the Pharyngeal Mucosa by the Investigator on a 5-point VRS at Pre-dose Baseline and at the End-of-study Evaluation | Assessment of redness of the pharyngeal mucosa by the investigator on a 5-point VRS (normal, slightly red, clearly red, very red, severe inflammation) at pre-dose baseline and at the end-of-study evaluation. | Day 1 and Day 2 |
| Assessment of Patients' Assessment of Effectiveness on a 5-point VRS at Pre-dose Baseline and at the End-of-study Evaluation | Assessment of Patients' Assessment of Effectiveness on a 5-point VRS ("very good", "good", "neither good nor poor", "not very good", "not at all good") at pre-dose baseline and at the end-of-study evaluation | Day 1 and Day 2 |
| Shanghai |
| China |
| ENT Subsidiary of Fudan University Hospital | Shanghai | China |
| Boehringer Ingelheim Investigational Site | Wuhan | China |
Patients were orally administered Placebo matching Ambroxol lozenges 20 mg initially (first lozenges); up to 6 lozenges per day up to two days.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
|
|
| Secondary | Pain Intensity (PI) as Rated on a 6-point VRS by the Patient at 0.5, 1, 2 and 3 Hours After the First Lozenge | Pain intensity (PI) as rated on a 6-point Verbal Rating Scale (VRS) by the patient at 0.5, 1, 2 and 3 hours after the first lozenge. The patient rates the intensity of his sore throat condition on a 6-point rating scale [VRS(PI)-verbal rating scale (pain intensity)] before taking the first lozenge and 30, 60, 120 and 180 minutes thereafter, and enters his rating in his patient's diary . The rating scale is as follows: 0=no pain; 1=hardly any pain; 2=slight pain; 3=moderate pain; 4=severe pain; 5=very severe pain. Adjusted Mean (Standard Error) are presented for this outcome measure. | FAS | Posted | Least Squares Mean | Standard Error | score on a scale | 0.5, 1, 2 and 3 hours |
|
|
|
|
| Secondary | Pain Intensity Difference From Pre-dose Baseline (PID) as Rated on a 6-point Verbal Rating Scale (VRS) by the Patient at 0.5, 1, 2 and 3 Hours After the First Lozenge | Pain intensity difference from pre-dose baseline (PID) as rated on a 6-point Verbal Rating Scale (VRS) by the patient at 0.5, 1, 2 and 3 hours after the first lozenge. Adjusted Mean (Standard Error) are presented for this outcome measure. | FAS | Posted | Least Squares Mean | Standard Error | score on a scale | pre-dose baseline and 0.5, 1, 2 and 3 hours |
|
|
|
|
| Secondary | Assessment of Redness of the Pharyngeal Mucosa by the Investigator on a 5-point VRS at Pre-dose Baseline and at the End-of-study Evaluation | Assessment of redness of the pharyngeal mucosa by the investigator on a 5-point VRS (normal, slightly red, clearly red, very red, severe inflammation) at pre-dose baseline and at the end-of-study evaluation. | SAFETY Set, which included all patients
| Posted | Number | percentage of participants | Day 1 and Day 2 |
|
|
|
|
| Secondary | Assessment of Patients' Assessment of Effectiveness on a 5-point VRS at Pre-dose Baseline and at the End-of-study Evaluation | Assessment of Patients' Assessment of Effectiveness on a 5-point VRS ("very good", "good", "neither good nor poor", "not very good", "not at all good") at pre-dose baseline and at the end-of-study evaluation | FAS | Posted | Number | percentage of participants | Day 1 and Day 2 |
|
|
|
|
| 0 |
| 124 |
| 0 |
| 124 |
| 0 |
| 124 |
| EG001 | Placebo | Patients were orally administered Placebo matching Ambroxol lozenges 20 mg initially (first lozenges); up to 6 lozenges per day up to two days. | 0 | 125 | 0 | 125 | 0 | 125 |
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| D012140 |
| Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D003514 |
| Cyclohexylamines |
| 120 minutes |
|
| 180 minutes |
|
| Analysis at 60 min: analysis of covariance (ANCOVA) including treatment and centre as fix effects and baseline as covariable are presented. Treatment differences are estimated by reference to the adjusted least squares mean differences and the corresponding 95 % confidence intervals. | ANCOVA | 0.0417 | Mean Difference (Final Values) | -0.2 | Standard Error of the Mean | 0.11 | 2-Sided | 95 | -0.4 | 0.0 | Treatment differences (Ambroxol- Placebo) | Other |
| Analysis at 120 min: analysis of covariance (ANCOVA) including treatment and centre as fix effects and baseline as covariable are presented. Treatment differences are estimated by reference to the adjusted least squares mean differences and the corresponding 95 % confidence intervals. | ANCOVA | 0.0054 | Mean Difference (Final Values) | -0.4 | Standard Error of the Mean | 0.13 | 2-Sided | 95 | -0.6 | -0.1 | Treatment differences (Ambroxol- Placebo | Other |
| Analysis at 180 min: analysis of covariance (ANCOVA) including treatment and centre as fix effects and baseline as covariable are presented. Treatment differences are estimated by reference to the adjusted least squares mean differences and the corresponding 95 % confidence intervals. | ANCOVA | 0.0201 | Mean Difference (Final Values) | -0.3 | Standard Error of the Mean | 0.13 | 2-Sided | 95 | -0.6 | 0.0 | Treatment differences (Ambroxol- Placebo | Other |
| 120 minutes |
|
| 180 minutes |
|
| Analysis at 60 min: analysis of covariance (ANCOVA) including treatment and centre as fix effects and baseline as covariable are presented. Treatment differences are estimated by reference to the adjusted least squares mean differences and the corresponding 95 % confidence intervals. | ANCOVA | 0.0417 | Mean Difference (Final Values) | -0.2 | Standard Error of the Mean | 0.11 | 2-Sided | 95 | -0.4 | 0.0 | Treatment differences (Ambroxol- Placebo | Other |
| Analysis at 120 min: analysis of covariance (ANCOVA) including treatment and centre as fix effects and baseline as covariable are presented. Treatment differences are estimated by reference to the adjusted least squares mean differences and the corresponding 95 % confidence intervals. | ANCOVA | 0.0054 | Mean Difference (Final Values) | -0.4 | Standard Error of the Mean | 0.13 | 2-Sided | 95 | -0.6 | -0.1 | Treatment differences (Ambroxol- Placebo | Other |
| Analysis at 180 min: analysis of covariance (ANCOVA) including treatment and centre as fix effects and baseline as covariable are presented. Treatment differences are estimated by reference to the adjusted least squares mean differences and the corresponding 95 % confidence intervals. | ANCOVA | 0.0201 | Mean Difference (Final Values) | -0.3 | Standard Error of the Mean | 0.13 | 2-Sided | 95 | -0.6 | 0.0 | Treatment differences (Ambroxol- Placebo | Other |
| Day 1_Slightly red |
|
|
| Day 1_ Clearly red |
|
|
| Day 1_Very red |
|
|
| Day 1_Severe inflammation |
|
|
| Day 2_Normal |
|
|
| Day 2_Slightly red |
|
|
| Day 2_Clearly red |
|
|
| Day 2_Very red |
|
|
| Day 2_Severe inflammation |
|
|
| Mantel Haenszel |
| 0.5552 |
| Other |
| Day 1_Good |
|
|
| Day 1_Neither good nor poor |
|
|
| Day 1_Not very good |
|
|
| Day 1_Not at all good |
|
|
| Day 2_Very good |
|
|
| Day 2_Good |
|
|
| Day 2_Neither good nor poor |
|
|
| Day 2_Not very good |
|
|
| Day 2_Not at all good |
|
|
| Mantel Haenszel |
| 0.0119 |
| Other |