| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated | | The study will be performed in patients suffering from acute sore throat not necessarily to be treated with antibiotics | |
| MedDRA Classification |
| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial | 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. | |
| E.2.2 | Secondary objectives of the trial | 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 | |
| E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
| E.3 | Principal 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.
| |
| E.4 | Principal 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.
| |
| E.5 End points |
| E.5.1 | Primary end point(s) | |
| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | No |
| E.6.3 | Therapy | No |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | Yes |
| E.6.6 | Pharmacokinetic | No |
| E.6.7 | Pharmacodynamic | No |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | No |
| E.6.10 | Pharmacogenetic | Information not present in EudraCT |
| E.6.11 | Pharmacogenomic | No |
| E.6.12 | Pharmacoeconomic | No |
| E.6.13 | Others | No |
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | No |
| E.7.1.1 | First administration to humans | No |
| E.7.1.2 | Bioequivalence study | No |
| E.7.1.3 | Other | No |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | No |
| E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
| E.7.4 | Therapeutic use (Phase IV) | No |
| E.8 Design of the trial |
| E.8.1 | Controlled | Yes |
| E.8.1.1 | Randomised | Yes |
| E.8.1.2 | Open | No |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | Yes |
| E.8.1.5 | Parallel group | Yes |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | No |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | No |
| E.8.2.2 | Placebo | Yes |
| E.8.2.3 | Other | No |
| E.8.3 | The trial involves single site in the Member State concerned | Yes |
| E.8.4 | The trial involves multiple sites in the Member State concerned | No |
| E.8.5 | The trial involves multiple Member States | No |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | No |
| E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
| E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
| E.8.8 | Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial | |
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | |
| E.8.9.1 | In the Member State concerned months | 4 |
| E.8.9.1 | In the Member State concerned days | |
