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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-021653-39 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lidocaine 8mg +CPC 2mg | Experimental | one single dose |
|
| Lidocaine 1mg + CPC 2mg | Active Comparator | one single dose |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine 8mg + CPC 2mg | Drug | one single dose |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline Sore Throat Pain Intensity | 100 milimeter (mm) visual acuity score (left=no pain=0mm, right=worst possible pain=100mm) | Baseline and 2 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 240 mn post-dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Investigator | SocraTec R&D GmbH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Socratec | Erfurt | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30541606 | Derived | 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. |
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14 Dec 2010 to 5 Apr 2011
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| ID | Title | Description |
|---|---|---|
| FG000 | Lidocaine 8mg +CPC 2mg | one single dose |
| FG001 | Lidocaine 1mg + CPC 2mg | one single dose |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Lidocaine 1mg + CPC 2mg |
| Drug |
one single dose |
|
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Lidocaine 8mg +CPC 2mg | one single dose |
| BG001 | Lidocaine 1mg + CPC 2mg | one single dose |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline Sore Throat Pain Intensity | 100 milimeter (mm) visual acuity score (left=no pain=0mm, right=worst possible pain=100mm) | Intent to treat | Posted | Mean | 95% Confidence Interval | mm | Baseline and 2 hours post-dose |
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| Secondary | 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. | intent to treat | Posted | Mean | 95% Confidence Interval | mm | Baseline and 240 mn post-dose |
|
|
14 Dec 2010 to 5 Apr 2011
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lidocaine 8mg +CPC 2mg | one single dose | 1 | 125 | 10 | 125 | ||
| EG001 | Lidocaine 1mg + CPC 2mg | one single dose | 0 | 125 | 9 | 125 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA |
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| Throat Irritation | Respiratory, thoracic and mediastinal disorders | MedDRA |
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| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA |
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| dizziness | Nervous system disorders | MedDRA |
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| hyperaesthesia | Nervous system disorders | MedDRA |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA |
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| Stridor | Respiratory, thoracic and mediastinal disorders | MedDRA |
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| vertigo | Nervous system disorders | MedDRA |
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Preliminary agreement between Novartis Consumer Health and the investigator
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Project Leader | Novartis Consumer Health, Nyon, Switzerland | +41223633279 | Rowland.Furcha@novartis.com |
| ID | Term |
|---|---|
| D010612 | Pharyngitis |
| D012141 | Respiratory Tract Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| C015101 | cytidylyl-(3'-5')-cytidine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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| >=65 years |
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| Male |
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