E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Respiratory Tract Diseases [C08] |
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 |
Safety and efficacy of Dorithricin® Halstabletten Classic (lozenges) |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Male and female outpatients aged ≥18 years • Signed informed consent form • Clinically diagnosed acute pharyngitis (Tonsillo-Pharyngitis Assessment (TPA) ≥5) • Recent onset of symptoms (≤24 hours) • Moderate or severe pain intensity (11-point numerical scale ≥6) • Difficulty in swallowing (100-mm VAS ≥50 mm) |
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E.4 | Principal exclusion criteria |
• patients with strong suspicion of streptococcus A infection (McIsaac Score ≥3) • Another acute episode of pharyngitis within the last 7 days prior to screening (the current acute pharyngitis which started within the last 24 hours is not meant) • Positive rapid streptococcus A test (rapid antigen detection test) to exclude the major bacterial pathogen responsible for sore throat •Purulent tonsillitis •Severe inflammations of the throat or throat pain that are accompanied by high fever (≥ 38,5°C, oral (sublingual)), headache, nausea and/or vomiting •The use of systemic antibiotics / local antibiotics in the throat area during the study and within the previous 7 days prior to screening •The use of any systemic analgesics / local analgesics in the throat area (e.g. non-steroidal drugs, ASA (> 100 mg), paracetamol) during the study or within the previous 36 hours prior to screening •The use of local anesthetics for treatment of sore throat during the study or within the previous 2 days prior to screening •The use of any other ‘sore throat medication’ (e.g. lozenges, drops, sprays) or other “cold medication” that could interfere the study results during the study and within the previous 7 days prior to screening •Major wounds of the mouth and throat •Immunodeficiency disorders (e.g. organ transplantation, HIV infection) •Severe neurologic and/or psychiatric disorders •Malignant ENT disorders within the previous 5 years •Known hypersensitivity to any of the ingredients of the study medication •Fructose intolerance •Women of child-bearing potential who do not use a highly effective method of contraception, that is the case when the Pearl Index of the contraceptive measure is ≥1 •Pregnancy and lactation •Participation in another clinical study during the study and within the previous 30 days prior to screening •Presence of drug or alcohol abuse •Persons who are institutionalized by court order or regulatory action • patients, who are members of the staff of the study center, staff of the sponsor or involved Clinical Research Organization (CRO), the investigator him- / herself or close relatives of the investigator • legal incapacity and/or other circumstances rendering the subject unable to understand the nature, scope and possible impact of the study
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint variable is defined as the percentage of patients with complete resolution of throat pain and difficulty in swallowing 48 hrs and 72 hrs after first application of treatment.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
At Visit 2 / Day 4 / T72 hrs. Analysis will be done after last patient last visit, data cleaning, data base lock and unblinding. |
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E.5.2 | Secondary end point(s) |
Efficacy - Free of Symptoms (asked once daily): 1. Percentage of patients free of throat pain and difficulty in swallowing evaluated separately after 48 hrs and after 72 hrs of treatment. 2. Percentage of patients free of throat pain analogously to the primary endpoint (repeated measures at 48 hrs and 72 hrs) and also evaluated separately after 48 hrs / 72 hrs. 3. Percentage of patients free of “difficulty in swallowing” analogously to the primary endpoint (repeated measures at 48 hrs and 72 hrs), and also evaluated separately after 48 hrs / 72 hrs 4. Time to free of symptom(s) of - throat pain - difficulty in swallowing
Efficacy - Symptom relief in the first two hours after first intake: 1. The sum of pain intensity differences over 2 hours after initial dose. 2. The sum of “difficulty in swallowing” differences over 2 hours after initial dose. 3. Time to pain relief defined as time till reduction of pain intensity by at least one score point. 4. Time to almost or complete pain relief defined as NRS ≤ 1 within 2 hours after initial dose. 5. Time to almost or complete relief in “difficulty in swallowing”, defined as VAS ≤ 1 within 2 hours after initial dose. 6. Percentage of patients with almost or complete pain relief defined as NRS ≤ 1 once occurred within 2 hours after initial dose. 7. Percentage of patients with almost or complete “difficulty in swallowing” defined as VAS ≤ 1 once occurred during 2 hours following initial dose.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Efficacy - Free of Symptoms Endpoints (asked once daily): 48 hrs and 72 hrs after start of treatment Efficacy - Endpoints with respect to symptom relief in the first two hours after first intake: 2 hrs after start of treatment
All analyses will be done after last patient last visit, data cleaning, data base lock and unblinding. |
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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 | Yes |
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 | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | Yes |
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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 25 |
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 | No |
E.8.7 | Trial has a data monitoring committee | No |
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
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End of the clinical trial: last patient last visit |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 5 |
E.8.9.1 | In the Member State concerned days | 0 |