Efficacy and tolerability of EPs 7630 solution in patients (> = 18 years old) with Acute Rhinopharyngitis (ARP)

Authors
Category Primary study
Registry of TrialsEU Clinical Trials Register
Year 2007
INTERVENTION: Trade Name: Umckaloabo® Product Code: EPs® 7630 solution Pharmaceutical Form: Oral drops, solution Pharmaceutical form of the placebo: Oral drops, solution Route of administration of the placebo: Oral use CONDITION: Adult patients are suffering at an acute Rhinopharyngitis. They will take 10 days 3x 30 drops per day of the investigational product and they will have 4 Visits. PRIMARY OUTCOME: Main Objective: Evaluation of the efficacy of EPs 7630 solution in patients (> = 18 years old) suffering from acute rhinopharyngitis (ARP). Evaluation is primarily done by the area under the curve (AUC) of total score of rhinopharyngitis‐relevant symptoms (RPS) between baseline (visit 1) and day 5 (visit 3). Primary end point(s): Secondary Objective: Efficacy: Change in total score of rhinopahryngitis‐ relevant symptoms, number of patients with complete remission, change in individual rhinopharyngitis‐relevant symptoms (RPS), change in individual further rhinopharyngitis‐relevant complaints, number of patients who experience a reduction in total score of RPS of at least 50% between baseline and day 5, sleep quality, Health‐related Quality of Life, patient´s satisfaction with treatment, consumption of paracetamol tablets, Tratment outcome (IMOS); Safety: Number, kind and severity of adverse events, laboratory examination 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
Epistemonikos ID: 4238d71374017ddc17c8476cfcee82a2b24bf932
First added on: Aug 21, 2024