Trial Outcomes & Findings for Double-blind Trial to Investigate Efficacy and Tolerance of Ambroxol Lozenges 20 mg in Sore Throat (NCT NCT00525044)
NCT ID: NCT00525044
Last Updated: 2019-07-11
Results Overview
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.
COMPLETED
PHASE3
249 participants
pre-dose baseline and 30, 60, 120, and 180 minutes
2019-07-11
Participant Flow
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.
Double-blind, randomized, placebo-controlled parallel design in comparison of two arms
Participant milestones
| Measure |
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
|
Placebo
Patients were orally administered Placebo matching Ambroxol lozenges 20 mg initially (first lozenges); up to 6 lozenges per day up to two days.
|
|---|---|---|
|
Overall Study
STARTED
|
124
|
125
|
|
Overall Study
COMPLETED
|
124
|
124
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
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
|
Placebo
Patients were orally administered Placebo matching Ambroxol lozenges 20 mg initially (first lozenges); up to 6 lozenges per day up to two days.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Double-blind Trial to Investigate Efficacy and Tolerance of Ambroxol Lozenges 20 mg in Sore Throat
Baseline characteristics by cohort
| Measure |
Ambroxol Lozenges 20 mg
n=124 Participants
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
|
Placebo
n=125 Participants
Patients were orally administered Placebo matching Ambroxol lozenges 20 mg initially (first lozenges); up to 6 lozenges per day up to two days.
|
Total
n=249 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
36.0 years
STANDARD_DEVIATION 12.2 • n=99 Participants
|
38.4 years
STANDARD_DEVIATION 13.0 • n=107 Participants
|
37.2 years
STANDARD_DEVIATION 12.7 • n=206 Participants
|
|
Sex: Female, Male
Female
|
67 Participants
n=99 Participants
|
71 Participants
n=107 Participants
|
138 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
57 Participants
n=99 Participants
|
54 Participants
n=107 Participants
|
111 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: pre-dose baseline and 30, 60, 120, and 180 minutesPopulation: 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.
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.
Outcome measures
| Measure |
Ambroxol Lozenges 20 mg
n=124 Participants
Patients were orally administered Ambroxol lozenges 20 mg initially (first lozenges); up to 6 lozenges per day up to two days, maximal dose:120 mg per day
|
Placebo
n=125 Participants
Patients were orally administered Placebo matching Ambroxol lozenges 20 mg initially (first lozenges); up to 6 lozenges per day up to two days.
|
|---|---|---|
|
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 0.020
|
-0.34 ratio
Standard Error 0.020
|
SECONDARY outcome
Timeframe: 0.5, 1, 2 and 3 hoursPopulation: FAS
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.
Outcome measures
| Measure |
Ambroxol Lozenges 20 mg
n=124 Participants
Patients were orally administered Ambroxol lozenges 20 mg initially (first lozenges); up to 6 lozenges per day up to two days, maximal dose:120 mg per day
|
Placebo
n=125 Participants
Patients were orally administered Placebo matching Ambroxol lozenges 20 mg initially (first lozenges); up to 6 lozenges per day up to two days.
|
|---|---|---|
|
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
|
2.8 score on a scale
Standard Error 0.08
|
|
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
|
3.1 score on a scale
Standard Error 0.07
|
|
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 0.10
|
2.7 score on a scale
Standard Error 0.09
|
|
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 0.10
|
2.5 score on a scale
Standard Error 0.10
|
SECONDARY outcome
Timeframe: pre-dose baseline and 0.5, 1, 2 and 3 hoursPopulation: FAS
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.
Outcome measures
| Measure |
Ambroxol Lozenges 20 mg
n=124 Participants
Patients were orally administered Ambroxol lozenges 20 mg initially (first lozenges); up to 6 lozenges per day up to two days, maximal dose:120 mg per day
|
Placebo
n=125 Participants
Patients were orally administered Placebo matching Ambroxol lozenges 20 mg initially (first lozenges); up to 6 lozenges per day up to two days.
|
|---|---|---|
|
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 0.10
|
-1.4 score on a scale
Standard Error 0.09
|
|
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 0.10
|
-1.6 score on a scale
Standard Error 0.10
|
|
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
|
-1.0 score on a scale
Standard Error 0.07
|
|
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
|
-1.2 score on a scale
Standard Error 0.08
|
SECONDARY outcome
Timeframe: Day 1 and Day 2Population: SAFETY Set, which included all patients * who were randomized, * who took at least one dose of trial medication.
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.
Outcome measures
| Measure |
Ambroxol Lozenges 20 mg
n=124 Participants
Patients were orally administered Ambroxol lozenges 20 mg initially (first lozenges); up to 6 lozenges per day up to two days, maximal dose:120 mg per day
|
Placebo
n=125 Participants
Patients were orally administered Placebo matching Ambroxol lozenges 20 mg initially (first lozenges); up to 6 lozenges per day up to two days.
|
|---|---|---|
|
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
|
0.8 percentage of participants
|
|
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
|
12.8 percentage of participants
|
|
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
|
50.4 percentage of participants
|
|
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
|
32.0 percentage of participants
|
|
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
|
4.0 percentage of participants
|
|
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
|
10.5 percentage of participants
|
|
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
|
66.9 percentage of participants
|
|
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
|
21.8 percentage of participants
|
|
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
|
0.8 percentage of participants
|
|
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
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: Day 1 and Day 2Population: FAS
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
Outcome measures
| Measure |
Ambroxol Lozenges 20 mg
n=124 Participants
Patients were orally administered Ambroxol lozenges 20 mg initially (first lozenges); up to 6 lozenges per day up to two days, maximal dose:120 mg per day
|
Placebo
n=125 Participants
Patients were orally administered Placebo matching Ambroxol lozenges 20 mg initially (first lozenges); up to 6 lozenges per day up to two days.
|
|---|---|---|
|
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
|
8.0 percentage of participants
|
|
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
|
52.0 percentage of participants
|
|
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
|
18.4 percentage of participants
|
|
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
|
16.0 percentage of participants
|
|
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
|
5.6 percentage of participants
|
|
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
|
14.2 percentage of participants
|
|
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
|
52.2 percentage of participants
|
|
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
|
16.8 percentage of participants
|
|
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
|
13.3 percentage of participants
|
|
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
|
3.5 percentage of participants
|
Adverse Events
Ambroxol Lozenges 20 mg
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place