Sore Throat Due to a Common ColdPhase 3NCT01265446
Efficacy and Safety of a Sore Throat Lozenge Containing Lidocaine and Cetylpyridinium Chloride in Patients With Sore Throat Due to a Common Cold.
A Phase 3 study testing Lidocaine 8mg + CPC 2mg and Lidocaine 1mg + CPC 2mg in people with Sore Throat Due to a Common Cold, run by Novartis at 1 site in Germany.
Trial summary
This study will compare the efficacy and safety of a single dose of a lidocaine 8 mg + cetylpyridimium chloride (CPC) 2 mg lozenge with a single dose of a lidocaine 1 mg + CPC 2 mg lozenge in the treatment of sore throat due to a common cold. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sore Throat Due to a Common Cold
- What is being tested?
- Lidocaine 8mg + CPC 2mg and Lidocaine 1mg + CPC 2mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2010to Apr 2011
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with sore throat due to an upper respiratory tract infection, with recent onset (within 48 hours)
- Sore throat of at least moderate pain intensity
Who cannot join
- - History of hypersensitivity to any of the study drugs and listed excipients or to drugs of similar chemical classes
- Evidence of mouth breathing or severe coughing
- Evidence of overt oropharyngeal bacterial or fungal infection or evidence of lower respirator tract infection
- Severe renal, liver or cardiac impairment
- Severe lung disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Parallel Group, Single-dose Study of the Efficacy of Lidocaine 8 mg + Cetylpyridinium Chloride (CPC) 2 mg Fixed Combination Lozenges on Sore Throat Pain Intensity Compared to Lozenges Containing Lidocaine 1 mg and CPC 2 mg in Subjects With Sore Throat Due to Upper Respiratory Tract Infection.
This study will compare the efficacy and safety of a single dose of a lidocaine 8 mg + cetylpyridimium chloride (CPC) 2 mg lozenge with a single dose of a lidocaine 1 mg + CPC 2 mg lozenge in the treatment of sore throat due to a common cold.
- Conditions
- Sore Throat Due to a Common Cold
- Being tested
- Lidocaine 8mg + CPC 2mg, Lidocaine 1mg + CPC 2mg
- Keywords
- Sore throat, upper respiratory tract infection, lozenge with lidocaine and cetylpyridinium chloride.
- Medical subject headings
- Pharyngitis, Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine 8mg + CPC 2mgDrug
one single dose
Lidocaine 1mg + CPC 2mgDrug
one single dose
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine 8mg +CPC 2mg | Experimental | one single dose Receives: Drug: Lidocaine 8mg + CPC 2mg |
| Lidocaine 1mg + CPC 2mg | Active comparator | one single dose Receives: Drug: Lidocaine 1mg + CPC 2mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline Sore Throat Pain Intensity
100 milimeter (mm) visual acuity score (left=no pain=0mm, right=worst possible pain=100mm)
Measured: Baseline and 2 hours post-dose
Secondary outcomes (1)
Change From Baseline Sore Throat Pain Intensity up to 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.
Measured: Baseline and 240 mn post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2010 (estimated)
- Study startDec 2010
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sore Throat Due to a Common ColdStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Investigator, Principal investigator, SocraTec R&D GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01265446
- Sponsor's protocol ID
- 075-A-301
- Other IDs
- 2010-021653-39
- Status last verified
- Apr 2013
- First submitted
- 20 Dec 2010
- Last updated
- 24 Apr 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Donath F, Mallefet P, Garreffa S, Furcha R. Efficacy of 8 mg lidocaine and 2 mg cetylpyridinium chloride (CPC) fixed-combination lozenges on sore throat pain intensity compared with 1 mg lidocaine and 2 mg CPC fixed-combination lozenges in subjects with sore throat due to upper respiratory tract infection: a randomized double-blind parallel-group single-dose study. Trials. 2018 Dec 12;19(1):679. doi: 10.1186/s13063-018-3077-6.
PubMed 30541606
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Parallel Group, Single-dose Study of the Efficacy of Lidocaine 8 mg + Cetylpyridinium Chloride (CPC) 2 mg Fixed Combination Lozenges on Sore Throat Pain Intensity Compared to Lozenges Containing Lidocaine 1 mg and CPC 2 mg in Subjects With Sore Throat Due to Upper Respiratory Tract Infection.
- ClinicalTrials.gov ID
- NCT01265446
- Acronym / sponsor ID
- 075-A-301
- Conditions
- Sore Throat Due to a Common Cold
- Keywords
- Sore throat, upper respiratory tract infection, lozenge with lidocaine and cetylpyridinium chloride.
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 23 Dec 2010 (estimated)
- Results
- Posted 26 Jul 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare the efficacy and safety of a single dose of a lidocaine 8 mg + cetylpyridimium chloride (CPC) 2 mg lozenge with a single dose of a lidocaine 1 mg + CPC 2 mg lozenge in the treatment of sore throat due to a common cold.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidocaine 8mg +CPC 2mg | Experimental | Drug: Lidocaine 8mg + CPC 2mgone single dose |
| Lidocaine 1mg + CPC 2mg | Active comparator | Drug: Lidocaine 1mg + CPC 2mgone single dose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with sore throat due to an upper respiratory tract infection, with recent onset (within 48 hours)
- Sore throat of at least moderate pain intensity
Key exclusion criteria (5 listed)
- - History of hypersensitivity to any of the study drugs and listed excipients or to drugs of similar chemical classes
- Evidence of mouth breathing or severe coughing
- Evidence of overt oropharyngeal bacterial or fungal infection or evidence of lower respirator tract infection
- Severe renal, liver or cardiac impairment
- Severe lung disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lidocaine 8mg + CPC 2mgone single dose | Drug | Lidocaine 8mg +CPC 2mg |
| Lidocaine 1mg + CPC 2mgone single dose | Drug | Lidocaine 1mg + CPC 2mg |
Primary outcome
Change From Baseline Sore Throat Pain Intensity
Time frame: Baseline and 2 hours post-dose
100 milimeter (mm) visual acuity score (left=no pain=0mm, right=worst possible pain=100mm)
1 secondary outcome
Change From Baseline Sore Throat Pain Intensity up to 240 mn Post-dose
Time frame: Baseline and 240 mn post-dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30541606Donath F, Mallefet P, Garreffa S, Furcha R. Efficacy of 8 mg lidocaine and 2 mg cetylpyridinium chloride (CPC) fixed-combination lozenges on sore throat pain intensity compared with 1 mg lidocaine and 2 mg CPC fixed-combination lozenges in subjects with sore throat due to upper respiratory tract infection: a randomized double-blind parallel-group single-dose study. Trials. 2018 Dec 12;19(1):679. doi: 10.1186/s13063-018-3077-6.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Investigator principal investigator
SocraTec R&D GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lidocaine 8mg + CPC 2mg and Lidocaine 1mg + CPC 2mg in people with Sore Throat Due to a Common Cold, run by Novartis at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jul 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline Sore Throat Pain Intensity (time frame: Baseline and 2 hours post-dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01265446, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2013.