Pharyngitis
Conditions
Brief summary
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.
Detailed description
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): 1. Patient's assessment of effectiveness and tolerance. The patient assesses the effectiveness and the tolerance of the test medicine for treating his sore throat at the end of the first and second day of treatment, by means of a verbal rating scale. 2. Participating doctors assessment of tolerance.
Interventions
DRUGAmbroxol
DRUGPlacebo
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
16 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
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. 1. Patients with symptoms of primarily bacterial pharyngitis or bacterial secondary infection (clinical findings; inter alia assessment of exudate). 2. First indication of symptoms of acute pharyngitis (e.g., sore throat) occurred more than 3 days ago already. 3. Counting of white blood cell in blood routine examination exceeds 10?109/L. 4. Patients who suffered from acute viral or bacterial pharyngitis in the past 4 weeks. 5. Broncho-motor disorders or concomitant diseases with relatively large quantities of secretion (danger of secretion blockage). 6. Known hypersensitivity to Ambroxol or to auxiliary substances contained in the tablet. 7. Previous and/or existing tumour condition. 8. Pregnancy and/or breast-feeding. 9. Alcohol, and/or drug abuse. 10. Simultaneous participation in another clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | pre-dose baseline and 30, 60, 120, and 180 minutes | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 0.5, 1, 2 and 3 hours | 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. |
| 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 | pre-dose baseline and 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. Adjusted Mean (Standard Error) are presented for this outcome measure. |
| 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 | Day 1 and Day 2 | 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. |
| Assessment of Patients' Assessment of Effectiveness on a 5-point VRS 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 (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 |
Countries
China
Participant flow
Recruitment details
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.
Pre-assignment details
Double-blind, randomized, placebo-controlled parallel design in comparison of two arms
Participants by arm
| Arm | Count |
|---|---|
| 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 | 124 |
| Placebo Patients were orally administered Placebo matching Ambroxol lozenges 20 mg initially (first lozenges); up to 6 lozenges per day up to two days. | 125 |
| Total | 249 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
Baseline characteristics
| Characteristic | Ambroxol Lozenges 20 mg | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 36.0 years STANDARD_DEVIATION 12.2 | 38.4 years STANDARD_DEVIATION 13 | 37.2 years STANDARD_DEVIATION 12.7 |
| Sex: Female, Male Female | 67 Participants | 71 Participants | 138 Participants |
| Sex: Female, Male Male | 57 Participants | 54 Participants | 111 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 124 | 0 / 125 |
| other Total, other adverse events | 0 / 124 | 0 / 125 |
| serious Total, serious adverse events | 0 / 124 | 0 / 125 |
Outcome results
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.
Time frame: pre-dose baseline and 30, 60, 120, and 180 minutes
Population: Full Analysis Set (FAS): FAS, which included all patients~* who were randomized,~* who took at least the first lozenge,~* who had PI data of baseline.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Ambroxol Lozenges 20 mg | 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 | -0.40 ratio | Standard Error 0.02 |
| Placebo | 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 | -0.34 ratio | Standard Error 0.02 |
Comparison: Differences between the treatment groups with regard to the primary endpoint SPIDnorm was tested using an analysis of variance (ANOVA) including treatment and centre as fix effects.~Treatment differences were estimated by reference to the adjusted least squares mean differences and the corresponding 95 % confidence intervals.p-value: 0.015695% CI: [-0.12, -0.01]ANOVA
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
Time frame: Day 1 and Day 2
Population: FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ambroxol Lozenges 20 mg | Assessment of Patients' Assessment of Effectiveness on a 5-point VRS at Pre-dose Baseline and at the End-of-study Evaluation | Day 1_Very good | 13.7 percentage of participants |
| Ambroxol Lozenges 20 mg | Assessment of Patients' Assessment of Effectiveness on a 5-point VRS at Pre-dose Baseline and at the End-of-study Evaluation | Day 1_Good | 58.1 percentage of participants |
| Ambroxol Lozenges 20 mg | Assessment of Patients' Assessment of Effectiveness on a 5-point VRS at Pre-dose Baseline and at the End-of-study Evaluation | Day 1_Neither good nor poor | 19.4 percentage of participants |
| Ambroxol Lozenges 20 mg | Assessment of Patients' Assessment of Effectiveness on a 5-point VRS at Pre-dose Baseline and at the End-of-study Evaluation | Day 1_Not very good | 6.5 percentage of participants |
| Ambroxol Lozenges 20 mg | Assessment of Patients' Assessment of Effectiveness on a 5-point VRS at Pre-dose Baseline and at the End-of-study Evaluation | Day 1_Not at all good | 2.4 percentage of participants |
| Ambroxol Lozenges 20 mg | Assessment of Patients' Assessment of Effectiveness on a 5-point VRS at Pre-dose Baseline and at the End-of-study Evaluation | Day 2_Very good | 24.3 percentage of participants |
| Ambroxol Lozenges 20 mg | Assessment of Patients' Assessment of Effectiveness on a 5-point VRS at Pre-dose Baseline and at the End-of-study Evaluation | Day 2_Good | 56.8 percentage of participants |
| Ambroxol Lozenges 20 mg | Assessment of Patients' Assessment of Effectiveness on a 5-point VRS at Pre-dose Baseline and at the End-of-study Evaluation | Day 2_Neither good nor poor | 14.4 percentage of participants |
| Ambroxol Lozenges 20 mg | Assessment of Patients' Assessment of Effectiveness on a 5-point VRS at Pre-dose Baseline and at the End-of-study Evaluation | Day 2_Not very good | 3.6 percentage of participants |
| Ambroxol Lozenges 20 mg | Assessment of Patients' Assessment of Effectiveness on a 5-point VRS at Pre-dose Baseline and at the End-of-study Evaluation | Day 2_Not at all good | 0.9 percentage of participants |
| Placebo | Assessment of Patients' Assessment of Effectiveness on a 5-point VRS at Pre-dose Baseline and at the End-of-study Evaluation | Day 2_Neither good nor poor | 16.8 percentage of participants |
| Placebo | Assessment of Patients' Assessment of Effectiveness on a 5-point VRS at Pre-dose Baseline and at the End-of-study Evaluation | Day 1_Very good | 8.0 percentage of participants |
| Placebo | Assessment of Patients' Assessment of Effectiveness on a 5-point VRS at Pre-dose Baseline and at the End-of-study Evaluation | Day 2_Very good | 14.2 percentage of participants |
| Placebo | Assessment of Patients' Assessment of Effectiveness on a 5-point VRS at Pre-dose Baseline and at the End-of-study Evaluation | Day 1_Good | 52.0 percentage of participants |
| Placebo | Assessment of Patients' Assessment of Effectiveness on a 5-point VRS at Pre-dose Baseline and at the End-of-study Evaluation | Day 2_Not at all good | 3.5 percentage of participants |
| Placebo | Assessment of Patients' Assessment of Effectiveness on a 5-point VRS at Pre-dose Baseline and at the End-of-study Evaluation | Day 1_Neither good nor poor | 18.4 percentage of participants |
| Placebo | Assessment of Patients' Assessment of Effectiveness on a 5-point VRS at Pre-dose Baseline and at the End-of-study Evaluation | Day 2_Good | 52.2 percentage of participants |
| Placebo | Assessment of Patients' Assessment of Effectiveness on a 5-point VRS at Pre-dose Baseline and at the End-of-study Evaluation | Day 1_Not very good | 16.0 percentage of participants |
| Placebo | Assessment of Patients' Assessment of Effectiveness on a 5-point VRS at Pre-dose Baseline and at the End-of-study Evaluation | Day 2_Not very good | 13.3 percentage of participants |
| Placebo | Assessment of Patients' Assessment of Effectiveness on a 5-point VRS at Pre-dose Baseline and at the End-of-study Evaluation | Day 1_Not at all good | 5.6 percentage of participants |
Comparison: Analysis at day 1:~P-value was calculated by the Cochran-Mantel-Haenszel test adjusting for center.p-value: 0.0343Mantel Haenszel
Comparison: Analysis at day 2:~P-value was calculated by the Cochran-Mantel-Haenszel test adjusting for center.p-value: 0.0119Mantel Haenszel
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.
Time frame: Day 1 and Day 2
Population: SAFETY Set, which included all patients~* who were randomized,~* who took at least one dose of trial medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ambroxol Lozenges 20 mg | 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 | Day 1_Normal | 0.0 percentage of participants |
| Ambroxol Lozenges 20 mg | 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 | Day 1_Slightly red | 12.1 percentage of participants |
| Ambroxol Lozenges 20 mg | 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 | Day 1_ Clearly red | 53.2 percentage of participants |
| Ambroxol Lozenges 20 mg | 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 | Day 1_Very red | 29.8 percentage of participants |
| Ambroxol Lozenges 20 mg | 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 | Day 1_Severe inflammation | 4.8 percentage of participants |
| Ambroxol Lozenges 20 mg | 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 | Day 2_Normal | 12.1 percentage of participants |
| Ambroxol Lozenges 20 mg | 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 | Day 2_Slightly red | 66.9 percentage of participants |
| Ambroxol Lozenges 20 mg | 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 | Day 2_Clearly red | 18.5 percentage of participants |
| Ambroxol Lozenges 20 mg | 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 | Day 2_Very red | 2.4 percentage of participants |
| Ambroxol Lozenges 20 mg | 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 | Day 2_Severe inflammation | 0.0 percentage of participants |
| Placebo | 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 | Day 2_Clearly red | 21.8 percentage of participants |
| Placebo | 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 | Day 1_Normal | 0.8 percentage of participants |
| Placebo | 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 | Day 2_Normal | 10.5 percentage of participants |
| Placebo | 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 | Day 1_Slightly red | 12.8 percentage of participants |
| Placebo | 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 | Day 2_Severe inflammation | 0.0 percentage of participants |
| Placebo | 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 | Day 1_ Clearly red | 50.4 percentage of participants |
| Placebo | 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 | Day 2_Slightly red | 66.9 percentage of participants |
| Placebo | 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 | Day 1_Very red | 32.0 percentage of participants |
| Placebo | 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 | Day 2_Very red | 0.8 percentage of participants |
| Placebo | 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 | Day 1_Severe inflammation | 4.0 percentage of participants |
Comparison: Analysis at day 1:~P-value was calculated by the Cochran-Mantel-Haenszel test adjusting for center.p-value: 0.9939Mantel Haenszel
Comparison: Analysis at day 2:~P-value was calculated by the Cochran-Mantel-Haenszel test adjusting for center.p-value: 0.5552Mantel Haenszel
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.
Time frame: pre-dose baseline and 0.5, 1, 2 and 3 hours
Population: FAS
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Ambroxol Lozenges 20 mg | 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 | 30 minutes | -1.1 score on a scale | Standard Error 0.08 |
| Ambroxol Lozenges 20 mg | 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 | 60 minutes | -1.4 score on a scale | Standard Error 0.08 |
| Ambroxol Lozenges 20 mg | 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 | 120 minutes | -1.8 score on a scale | Standard Error 0.1 |
| Ambroxol Lozenges 20 mg | 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 | 180 minutes | -1.9 score on a scale | Standard Error 0.1 |
| Placebo | 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 | 180 minutes | -1.6 score on a scale | Standard Error 0.1 |
| Placebo | 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 | 30 minutes | -1.0 score on a scale | Standard Error 0.07 |
| Placebo | 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 | 120 minutes | -1.4 score on a scale | Standard Error 0.09 |
| Placebo | 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 | 60 minutes | -1.2 score on a scale | Standard Error 0.08 |
Comparison: Analysis at 30 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.p-value: 0.12895% CI: [-0.4, 0]ANCOVA
Comparison: 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.p-value: 0.041795% CI: [-0.4, 0]ANCOVA
Comparison: 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.p-value: 0.005495% CI: [-0.6, -0.1]ANCOVA
Comparison: 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.p-value: 0.020195% CI: [-0.6, 0]ANCOVA
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.
Time frame: 0.5, 1, 2 and 3 hours
Population: FAS
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Ambroxol Lozenges 20 mg | 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 | 30 minutes | 2.9 score on a scale | Standard Error 0.08 |
| Ambroxol Lozenges 20 mg | 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 | 60 minutes | 2.6 score on a scale | Standard Error 0.08 |
| Ambroxol Lozenges 20 mg | 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 | 120 minutes | 2.3 score on a scale | Standard Error 0.1 |
| Ambroxol Lozenges 20 mg | 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 | 180 minutes | 2.2 score on a scale | Standard Error 0.1 |
| Placebo | 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 | 180 minutes | 2.5 score on a scale | Standard Error 0.1 |
| Placebo | 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 | 30 minutes | 3.1 score on a scale | Standard Error 0.07 |
| Placebo | 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 | 120 minutes | 2.7 score on a scale | Standard Error 0.09 |
| Placebo | 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 | 60 minutes | 2.8 score on a scale | Standard Error 0.08 |
Comparison: Analysis at 30 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.p-value: 0.12895% CI: [-0.4, 0]ANCOVA
Comparison: 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.p-value: 0.041795% CI: [-0.4, 0]ANCOVA
Comparison: 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.p-value: 0.005495% CI: [-0.6, -0.1]ANCOVA
Comparison: 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.p-value: 0.020195% CI: [-0.6, 0]ANCOVA