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 2008
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 suffering from acute Rhinopharyngitis. 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 the total score of rhinopharyngitis‐relevant symptoms (RPS) between baseline (visit 1, day 1) and day 5 (visit 3). 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). Secondary Objective: Efficacy: Change in total score of rhinopharyngitis‐relevant symptoms, number of patients who experience a reduction in total score of RPS, number of patients with complete remission, change in individual 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 (IMPSS), consumption of paracetamol tablets, treatment outcome (IMOS). Safety: Adverse events surveillance, laboratory safety parameters.; 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)
Epistemonikos ID: 646c2fdb0b26debedbfda4a6c72933c80490d529
First added on: Aug 21, 2024