Trial · NCT01265446
Efficacy and Safety of a Sore Throat Lozenge Containing Lidocaine and Cetylpyridinium Chloride in Patients With Sore Throat Due to a Common Cold.
NCT01265446, Phase 3, Completed, Novartis; results first posted 2012-07-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety of a Sore Throat Lozenge Containing Lidocaine and Cetylpyridinium Chloride in Patients With Sore Throat Due to a Common Cold. Trials, record NCT01265446. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01265446
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of a Sore Throat Lozenge Containing Lidocaine and Cetylpyridinium Chloride in Patients With Sore Throat Due to a Common Cold.
- NCT number
- NCT01265446
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 250 participants, actual
- Lead sponsor
- Novartis
- Conditions
- Sore Throat Due to a Common Cold
- Interventions
- Lidocaine 8mg + CPC 2mg, Lidocaine 1mg + CPC 2mg
- First posted
- 2010-12-23
- Last updated
- 2013-04-24
- Other registries' IDs
- eudract:2010-021653-39
- Results first posted
- 2012-07-26
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline Sore Throat Pain Intensity | Baseline and 2 hours post-dose | 100 milimeter (mm) visual acuity score (left=no pain=0mm, right=worst possible pain=100mm) |
| Secondary | Change From Baseline Sore Throat Pain Intensity up to 240 mn Post-dose | Baseline and 240 mn post-dose | 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. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline Sore Throat Pain Intensity | Baseline and 2 hours post-dose | Intent to treat | mm | MEAN |
| SECONDARY | Change From Baseline Sore Throat Pain Intensity up to 240 mn Post-dose | Baseline and 240 mn post-dose | intent to treat | mm | MEAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline Sore Throat Pain Intensity | Lidocaine 8mg +CPC 2mg | -27.4 | 95% Confidence Interval -31.0 to -23.8 | mm | |
| Change From Baseline Sore Throat Pain Intensity | Lidocaine 1mg + CPC 2mg | -26.9 | 95% Confidence Interval -30.5 to -23.3 | mm | |
| Change From Baseline Sore Throat Pain Intensity up to 240 mn Post-dose | Lidocaine 8mg +CPC 2mg | -25.5 | 95% Confidence Interval -29.8 to -21.2 | mm | |
| Change From Baseline Sore Throat Pain Intensity up to 240 mn Post-dose | Lidocaine 1mg + CPC 2mg | -29.1 | 95% Confidence Interval -33.1 to -25.1 | mm |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Lidocaine 8mg +CPC 2mg | 125 | |
| Overall Study | STARTED | Lidocaine 1mg + CPC 2mg | 125 | |
| Overall Study | COMPLETED | Lidocaine 8mg +CPC 2mg | 124 | |
| Overall Study | COMPLETED | Lidocaine 1mg + CPC 2mg | 125 | |
| Overall Study | NOT COMPLETED | Lidocaine 8mg +CPC 2mg | 1 | |
| Overall Study | NOT COMPLETED | Lidocaine 1mg + CPC 2mg | 0 |
Source ClinicalTrials.gov
Adverse events18
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Headache | Nervous system disorders | Lidocaine 8mg +CPC 2mg | 7 | 125 | 7 |
| other | Headache | Nervous system disorders | Lidocaine 1mg + CPC 2mg | 6 | 125 | 6 |
| other | Throat Irritation | Respiratory, thoracic and mediastinal disorders | Lidocaine 8mg +CPC 2mg | 1 | 125 | 1 |
| other | Throat Irritation | Respiratory, thoracic and mediastinal disorders | Lidocaine 1mg + CPC 2mg | 1 | 125 | 1 |
| other | Asthma | Respiratory, thoracic and mediastinal disorders | Lidocaine 8mg +CPC 2mg | 0 | 125 | 0 |
| other | Asthma | Respiratory, thoracic and mediastinal disorders | Lidocaine 1mg + CPC 2mg | 1 | 125 | 1 |
| other | dizziness | Nervous system disorders | Lidocaine 8mg +CPC 2mg | 0 | 125 | 0 |
| other | dizziness | Nervous system disorders | Lidocaine 1mg + CPC 2mg | 1 | 125 | 1 |
| other | hyperaesthesia | Nervous system disorders | Lidocaine 8mg +CPC 2mg | 1 | 125 | 1 |
| other | hyperaesthesia | Nervous system disorders | Lidocaine 1mg + CPC 2mg | 0 | 125 | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lidocaine 8mg +CPC 2mg | ||
| Total, all-cause mortality | Lidocaine 1mg + CPC 2mg | ||
| Total, other adverse events | Lidocaine 8mg +CPC 2mg | 10 | 125 |
| Total, other adverse events | Lidocaine 1mg + CPC 2mg | 9 | 125 |
| Total, serious adverse events | Lidocaine 8mg +CPC 2mg | 1 | 125 |
| Total, serious adverse events | Lidocaine 1mg + CPC 2mg | 0 | 125 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30541606 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Lidocaine 8mg +CPC 2mg vs Lidocaine 1mg + CPC 2mg: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01265446
GET https://conductscience.org/api/trials/v1/NCT01265446/registered