The study will be performed in patients suffering from acute sore throat not necessarily to be treated with antibiotics
Conditions
Interventions
Trade Name: Trachisan® Halsschmerztabletten
Product Name: Lidocain 8 mg Halsschmerztabletten
Pharmaceutical Form: Lozenge
INN or Proposed INN: lidocaine
CAS Number: 137-58-6
Concentration unit: mg mil
Sponsors
Engelhard Arzneimittel GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients of both genders will be enrolled. They must fulfil all the following criteria before being enrolled in the study: - Age: > 18 years. - Patients with moderate to severe throat pain (³60 mm VAS) due to acute pharyngitis of recent onset (within preceding 48 hours) not requiring antibiotic treatment. - The patient must give written informed consent, after having been informed about benefits and potential risks of the trial, as well details of the insurance taken out to cover the subjects participating in the study. 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
Exclusion criteria: Patients are to be excluded from the study if they display any of the following criteria: - Hypersensitivity to lidocaine hydrochloride, local anaesthetics of the amide type or any of the excipients of the study drugs. - Known or suspected primary or secondary bacterial pharyngitis or tonsillopharyngitis (e.g. clinical finding of purulent, serous or fibrinous exudate from the pharyngeal mucosa). - Known or suspected oro-pharyngeal mycosis. - Presence of severely traumatised and / or very severe inflammation of the oro -pharyngeal mucosa. - Severe lower respiratory tract infection (pneumonia, bronchitis) requiring antibiotic treatment. - Acute rhino-sinusitis or laryngitis requiring antibiotic treatment. - Fever (>38°C oral). - Systemic treatment with analgesics (within the last 12 hours) or non-steroidal anti -inflammatory drugs, COX-2 inhibitors (within the last 24 hours) prior to enrolment except long-term treatment with low-dose ASA (£ 100 mg ASA per day). - Treatment with codeine containing cough preparations within the last 12 hours prior to enrolment. - Topical oro- or nasopharyngeal use of local anaesthetics and / or antiseptic formulations (such as lozenges, pharyngeal washes, breath spray, inhalation) or use of herbal teas used for the treatment of common cold within the last 6 hours prior to enrolment. - Concomitant systemic propranolol treatment. - Concomitant systemic cimetidine treatment unless the treatment will be interrupted the latest 6 hours prior to first intended lidocaine treatment. - Systemic or topical (oro-pharyngeal) treatment with an antibiotic agent within the last week prior to enrolment. - Known fructose intolerance. - Known medical condition associated with chronic pain, clinically relevant acute disease (at the investigator’s judgement), known current haematopoietic or malignant disorder. - Presence of relevant neurological or psychiatric disorder or mental impairment. - Pregnancy or breast feeding. - Women of childbearing potential unable or unwilling to practice adequate contraceptive measures. - Heavy smoker (³ 20 cigarettes per day). - Suspicion of alcohol abuse, drug addiction or any other condition of the patient that at the investigator’s discretion may jeopardise patient’s compliance or adherence to protocol requirements. - Previous participation in this study or participation in any other drug investigational trial within the preceding 30 days. - Volunteers suspected or known not to follow the instructions. The exclusion criteria are chosen to assure that patients with specific risks for administration of the investigated drug and patients with conditions which may have an impact on efficacy parameters are excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation of efficacy and safety of 8 mg lidocaine sore throat lozenges for the treatment of acute sore throat not necessarily to be treated with antibiotics compared to placebo. primary variable (AUC0h-2h of PID) will be analysed confirmatorily by a 2-sided t-test (at level 5%). A 2-sided confidence interval (95%) will be calculated for the difference (verum – placebo) of AUC of PID. In addition, all these analyses will be conducted for the PP population as sensitivity analysis.;Secondary Objective: secondary variables (PI related variables) will be described for the ITT population. global assessments of efficacy will be described by frequencies and percentages (related to number of patients with information) for the ITT population, "very good" / "good" will be combined. number of needed study medication will be described by frequencies for the ITT population. safety variables (safety population): adverse events will be coded according to MedDRA and evaluated on preferred term and system organ class level with regard to intensity, drug relationship and seriousness global assessments of tolerability will be described by frequencies and percentages (related to number of patients with information), "very good" / "good" will be combined vital signs will be analysed for each time point as well as for the difference to baseline oro-pharyngeal variables;Primary end point(s): not applicable | — |
Countries
Germany
Outcome results
None listed