Trial Outcomes & Findings for Efficacy and Safety of a Sore Throat Lozenge Containing Lidocaine and Cetylpyridinium Chloride in Patients With Sore Throat Due to a Common Cold. (NCT NCT01265446)
NCT ID: NCT01265446
Last Updated: 2013-04-24
Results Overview
100 milimeter (mm) visual acuity score (left=no pain=0mm, right=worst possible pain=100mm)
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
250 participants
Primary outcome timeframe
Baseline and 2 hours post-dose
Results posted on
2013-04-24
Participant Flow
14 Dec 2010 to 5 Apr 2011
Participant milestones
| Measure |
Lidocaine 8mg +CPC 2mg
one single dose
|
Lidocaine 1mg + CPC 2mg
one single dose
|
|---|---|---|
|
Overall Study
STARTED
|
125
|
125
|
|
Overall Study
COMPLETED
|
124
|
125
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Safety of a Sore Throat Lozenge Containing Lidocaine and Cetylpyridinium Chloride in Patients With Sore Throat Due to a Common Cold.
Baseline characteristics by cohort
| Measure |
Lidocaine 8mg +CPC 2mg
n=125 Participants
one single dose
|
Lidocaine 1mg + CPC 2mg
n=125 Participants
one single dose
|
Total
n=250 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
125 Participants
n=99 Participants
|
125 Participants
n=107 Participants
|
250 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age Continuous
|
32.1 years
STANDARD_DEVIATION 12.6 • n=99 Participants
|
31.6 years
STANDARD_DEVIATION 11.6 • n=107 Participants
|
31.9 years
STANDARD_DEVIATION 12.1 • n=206 Participants
|
|
Sex: Female, Male
Female
|
67 Participants
n=99 Participants
|
67 Participants
n=107 Participants
|
134 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
58 Participants
n=99 Participants
|
58 Participants
n=107 Participants
|
116 Participants
n=206 Participants
|
|
Region of Enrollment
Germany
|
125 participants
n=99 Participants
|
125 participants
n=107 Participants
|
250 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline and 2 hours post-dosePopulation: Intent to treat
100 milimeter (mm) visual acuity score (left=no pain=0mm, right=worst possible pain=100mm)
Outcome measures
| Measure |
Lidocaine 8mg +CPC 2mg
n=125 Participants
one single dose
|
Lidocaine 1mg + CPC 2mg
n=125 Participants
one single dose
|
|---|---|---|
|
Change From Baseline Sore Throat Pain Intensity
|
-27.4 mm
Interval -31.0 to -23.8
|
-26.9 mm
Interval -30.5 to -23.3
|
SECONDARY outcome
Timeframe: Baseline and 240 mn post-dosePopulation: intent to treat
100 milimeter (mm) visual acuity score (left=no pain=0mm, right=worst possible pain=100mm). It measures the highest pain level felt by the patient.
Outcome measures
| Measure |
Lidocaine 8mg +CPC 2mg
n=125 Participants
one single dose
|
Lidocaine 1mg + CPC 2mg
n=125 Participants
one single dose
|
|---|---|---|
|
Change From Baseline Sore Throat Pain Intensity up to 240 mn Post-dose
|
-25.5 mm
Interval -29.8 to -21.2
|
-29.1 mm
Interval -33.1 to -25.1
|
Adverse Events
Lidocaine 8mg +CPC 2mg
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Lidocaine 1mg + CPC 2mg
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lidocaine 8mg +CPC 2mg
n=125 participants at risk
one single dose
|
Lidocaine 1mg + CPC 2mg
n=125 participants at risk
one single dose
|
|---|---|---|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.80%
1/125 • Number of events 1 • 14 Dec 2010 to 5 Apr 2011
|
0.00%
0/125 • 14 Dec 2010 to 5 Apr 2011
|
Other adverse events
| Measure |
Lidocaine 8mg +CPC 2mg
n=125 participants at risk
one single dose
|
Lidocaine 1mg + CPC 2mg
n=125 participants at risk
one single dose
|
|---|---|---|
|
Nervous system disorders
Headache
|
5.6%
7/125 • Number of events 7 • 14 Dec 2010 to 5 Apr 2011
|
4.8%
6/125 • Number of events 6 • 14 Dec 2010 to 5 Apr 2011
|
|
Respiratory, thoracic and mediastinal disorders
Throat Irritation
|
0.80%
1/125 • Number of events 1 • 14 Dec 2010 to 5 Apr 2011
|
0.80%
1/125 • Number of events 1 • 14 Dec 2010 to 5 Apr 2011
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/125 • 14 Dec 2010 to 5 Apr 2011
|
0.80%
1/125 • Number of events 1 • 14 Dec 2010 to 5 Apr 2011
|
|
Nervous system disorders
dizziness
|
0.00%
0/125 • 14 Dec 2010 to 5 Apr 2011
|
0.80%
1/125 • Number of events 1 • 14 Dec 2010 to 5 Apr 2011
|
|
Nervous system disorders
hyperaesthesia
|
0.80%
1/125 • Number of events 1 • 14 Dec 2010 to 5 Apr 2011
|
0.00%
0/125 • 14 Dec 2010 to 5 Apr 2011
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.80%
1/125 • Number of events 1 • 14 Dec 2010 to 5 Apr 2011
|
0.00%
0/125 • 14 Dec 2010 to 5 Apr 2011
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
0.80%
1/125 • Number of events 1 • 14 Dec 2010 to 5 Apr 2011
|
0.00%
0/125 • 14 Dec 2010 to 5 Apr 2011
|
|
Nervous system disorders
vertigo
|
0.80%
1/125 • Number of events 1 • 14 Dec 2010 to 5 Apr 2011
|
0.00%
0/125 • 14 Dec 2010 to 5 Apr 2011
|
Additional Information
Clinical Project Leader
Novartis Consumer Health, Nyon, Switzerland
Phone: +41223633279
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Preliminary agreement between Novartis Consumer Health and the investigator
- Publication restrictions are in place
Restriction type: OTHER