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 Mebucaine CL lozenges (containing lidocaine 1 mg and CPC 2 mg) in subjects with sore throat due to upper respiratory tract infectio

• Conditions: Sore throat due to upper respiratory tract infection(Planned indication for approval:Local antiseptic and analgesic treatment of sore throat and minor infections of the mouth.Relief of pain as well as irritation associated with these conditions in adults and adolescents aged 12 years and above.); MedDRA version: 12.1Level: LLTClassification code 10041367Term: Sore throat; MedDRA version: 12.1Level: LLTClassification code 10068319Term: Oropharyngeal pain

• Registration Number: EUCTR2010-021653-39-DE
• Lead Sponsor: ovartis Consumer Health S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09-10
• Last Update Posted: 27 January 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Subjects eligible for inclusion in this study must fulfill all of the following criteria. Criteria 1-5 must be met at screening; criterion 5 must also be met immediately prior to dosing.
1.Given written informed consent before any assessment is performed.
2.Male or female aged 18 years or over.
3.A primary diagnosis of sore throat, of onset = 48 hours prior to screening, and = 56 hours prior to dosing, due to URTI
4.A Tonsillopharyngitis Assessment (TPA) score = 5 on the expanded TPA scale (Schachtel et al, 2002; Schachtel 1984c, Eccles et al 2003)
5.A Sore Throat Pain Intensity score of at least 60 mm on the Sore Throat Pain Intensity Scale (a Visual Analogue Scale of 100 mm ranging from no pain at the left and to worst possible pain at the right) both at screening and immediately before dosing. Subjects should be asked to swallow before Sore Throat Pain intensity is recorded.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Subjects must be excluded from this study if they fit any of the following criteria listed below at screening or at the beginning of the study. Criterion 22 must be regularly verified, from the clinical point of view, during the course of the study.
1.Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer
2.Women of child-bearing potential (defined as all women physiologically capable of becoming pregnant) who are not using an acceptable method of contraception defined as:
- Surgical sterilization
- Hormonal contraception
- IUD
- Double barrier method
- Total abstinence throughout the study at the discretion of the Investigator.
Periodic abstinence is NOT acceptable. An acceptable method of contraception must be maintained throughout the study.
A woman who is postmenopausal must have a negative urine pregnancy test at screening but will not need to comply with an acceptable method of contraception.
3.History of hypersensitivity to any of the study drugs and the listed excipients or to drugs of similar chemical classes
4.Evidence of mouth breathing such as significant nasal congestion in both nostrils (Schachtel et al. 1984b)
5.Evidence of severe coughing
6.Pregnant or nursing (lactating women); positive pregnancy test at screening.
7.Any disease that could compromise breathing e.g. bronchopneumonia
8.Use of any analgesic or NSAID within 5 half-lives prior to dosing
9.Use of any antipyretic, antitussive or decongestant medications within 8 hours prior to dosing.
10.Use of any medicated confectionary, throat lozenges, throat pastilles, sprays, any products with demulcent properties such as boiled sweets or mints, in the 2 hours prior to dosing.
11.Use of any medication for sore throat containing a local anaesthetic within the 4 hours prior to dosing.
12.Use of antibiotics within the previous 14 days.
13.Any painful condition with an intensity that it may distract attention from sore throat pain at the discretion of the investigator, including but not limited to mouth ulcers, joint pain, back pain, sinusitis.
14.Evidence of overt oropharyngeal bacterial or fungal infection (e.g. purulent exudate, oral candidiasis) or evidence of lower respiratory tract infection.
15.Severe renal, liver or cardiac impairment. Severe lung disease.
16.A history of alcohol abuse or an admission by the subject that they regularly consume alcoholic food or beverages of = 40 g pure ethanol for male or = 20 g for female per day .
17.Heavy smokers (use of 20 or more cigarettes per day)
18.History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
19.Those previously randomized into the study.
20.Those unable, in the opinion of the Investigator, to comply with the study requirements. e.g. those who cannot comprehend or correctly use the scales.
21.Employees or relatives of employees of the investigational site
22.Fever that, in the opinion of the investigator, may interfere with the ability of the subject to participate in the study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified