Adult patients suffering from Acute Rhinopharyngitis MedDRA version: 9.1 Level: LLT Classification code 10000938 Term: Acute nasopharyngitis (common cold)
Conditions
Interventions
Product Code: EPs® 7630 film-coated tablets
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Pelargonium sidoides extract ratio 1:8-10
extraction solvent: ethanol 11 % (w/w)
dried
Current Sponsor code: EPs® 7630
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administra
Sponsors
Dr. Willmar Schwabe GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Male and female patients >=18 years old (2) Written informed consent (3) Patients suffering from acute rhinopharyngitis (ARP) (4) Presence of (a) both major rhinopharyngitis-relevant symptoms (RPS) (nasal discharge and sore throat) with >= 2 points each and at least two minor RPS (nasal congestion, sneezing, scratchy throat, hoarseness, cough, headache, muscle aches, or fever) with >= 2 points each, or (b) one major RPS with >= 2 points and at least three minor RPS with >= 2 points each (5) Start of the acute rhinopharyngitis-relevant symptoms (RPS) 24-72 hours prior to inclusion into the study (6) Patients with willingness and ability to comply with all procedures of the trial and attend all scheduled visits at the investigational site 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: (1) Obstructive anatomic lesions in the nasopharynx such as nasal polyps, or severe septal deviations (2) Previous surgery (within the last 12 months prior to inclusion into the study) or need for surgery of the nose or paranasal sinuses incl. sinus puncture (3) Presence of any acute ENT diseases other than rhinopharyngitis and/or presence of respiratory tract disease (e.g. tonsillitis, sinusitis, otitis, bronchitis, pneumonia) (4) Patients with allergic rhinitis (5) Chronic lung diseases (e.g. chronic bronchitis, COPD, bronchial asthma, cystic fibrosis, active pulmonary tuberculosis, lung cancer) (6) Recurrent tonsillitis or otitis of > 3 episodes during the last 12 months prior to enrolment into the study (7) Recurrent bronchitis of > 6 episodes during the past 12 months prior to enrolment into the study (8) Recurrent sinusitis of > 3 episodes during the past 12 months prior to enrolment into the trial or chronic sinusitis (symptoms lasting for > 1 month) (9) Previous treatment with antibiotics, glucocorticosteroids or antihistamines within the last 4 weeks prior to enrolment into the trial (10) Previous (within the last 6 weeks prior to inclusion into the clinical trial) or concomitant treatment with anti-coagulants (11) Previous treatment with cold medications (e.g. decongestants, local anesthetics, zinc, Echinacea, vitamin C >=100 mg per day), anti-inflammatories, anti-tussiva, mucolytics, secretolytics, Pelargonium sidoides preparations, herbal treatment for cold, or pain relief medications (e.g. aspirin, paracetamol) within the last 7 days prior to enrolment into the trial (12) Concomitant medications that might impair the interpretation of trial results (e.g. antibiotics, glucocorticosteroids, antihistamines, any cold medications such as decongestants, zinc, Echinacea, vitamin C >= 100 mg per day , anti-inflammatories, secretolytics, anti-tussiva, mucolytics, herbal medications for respiratory tract infection other than the study medication, or pain relief medications other than paracetamol) (13) Known or suspected hypersensitivity to the investigational drug (14) Severe cardiovascular disease, unstable diabetes mellitus, or immunosuppression (15) Known severe renal or hepatic dysfunction (serum creatinine, serum AST, ALT or alkaline phosphatase >3 times above the upper limit of normal values) at any time during the past 12 months prior to enrolment into the trial (16) Significant symptoms within the last 6 months prior to enrolment into the study, e.g. un-unintentional weight loss, or any other sign indicating serious or malignant disease (17) Evidence of any malignant disease during the past 5 years prior to enrolment into the trial (18) Heavy smoking (= 25 cigarettes per day) (19) Intake of >= 500 mg caffeine per day (20) Known alcohol or drug abuse (21) Patients with tendency to bleed, specially nose or gingival bleeding (22) Known gastrointestinal disorders (e.g. partial or total gastrectomy, enterectomy, inflammatory bowel disease, celiac disease, symptomatic lactose intolerance, other disorders associated with chronic diarrhea) (23) Females of child-bearing potential with no adequate contraception (24) Pregnancy or lactation (25) Patients participating in another clinical trial at the same time or have taken part in a clinical trial during the last 4 weeks before inclusion into this study (26) Irresponsible patients or those unable to understand nature, meaning and consequences of the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Area under the curve (AUC) of the total score of rhinopharyngitis-relevant symptoms (RPS) from baseline (day 1, visit 1) to day 5 (visit 3);Main Objective: The primary objective of this clinical trial is to evaluate the efficacy of EPs? 7630 film-coated tablets in patients (>= 18 years old) suffering from acute rhinopharyngitis (ARP). Evaluation is primarily done by the area under the curve (AUC) of the total score of rhinopharyngitis-relevant symptoms (RPS) between baseline (visit 1, day 1) and day 5 (visit 3).;Secondary Objective: Efficacy: Change in total score of rhinopharyngitis-relevant symptoms (RPS), number of patients who experience a reduction in total score of RPS, number of patients with complete remission of RPS, change in individual rhinopharyngitis-relevant symptoms (RPS), patient´s ability to work or to attend school/college, sleep quality, health-related Quality of Life, patient´s satisfaction with treatment (IMPSS), consumption of paracetamol tablets, treatment outcome (IMOS) . Safety: Adverse events surveillance, laboratory safety parameters. | — |
Countries
Bulgaria
Outcome results
None listed