Clinical Trials Logo
  1. Home
  2. Pharyngitis
  3. NCT03323528

Safety and Efficacy of a Sore Throat Lozenge DORITHRICIN in Patients With Acute Pharyngitis — DoriPha  

Pharyngitis Clinical Trial

Official title:
A Multi-centre, Randomized, Placebo-controlled, Double-blind, Parallel-group Study Investigating Safety and Efficacy of a Sore Throat Lozenge in the Symptomatic Treatment of Patients With Acute Pharyngitis

Clinical Trial Summary

The aim of this multi-center, randomized, double-blind, placebo-controlled trial is to compare the efficacy and safety of Dorithricin® lozenge - a triple combination of 0.5 mg tyrothricin, 1.0 mg benzalkonium chloride, and 1.5 mg benzocaine - in repeat dosing for 3 days to matched placebo lozenges in the treatment of acute pharyngitis in adults.

Clinical Trial Description

In this randomized, double-blind, placebo-controlled trial, adult patients with non-streptococcal sore throat and signs of moderate-to-severe associated pain (pain intensity on the 11-point Sore Throat Pain Intensity Scale NRS ≥7 and ≥50 mm on the subjective 0-100 mm visual analogue) are assigned to Dorithricin® or matching placebo lozenge treatment. Efficacy was assessed at the investigating center for 2 hrs after first dosing, and 3 days later (visit 2). The primary efficacy end-point is the percentage of total responders assessed at visit 2, i.e. complete resolution of throat pain and difficulty in swallowing at approx. 72 hrs after first application of treatment, Safety and local tolerability are also assessed. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03323528
Study type Interventional
Source Medice Arzneimittel Pütter GmbH & Co KG
Contact
Status Completed
Phase Phase 4
Start date February 1, 2017
Completion date November 15, 2017
View Details
See also
  Status Clinical Trial Phase
Completed NCT01453400 - Evaluate the Time of Pain Relief of Fast Acting Aspirin Versus Acetaminophen in Subjects Diagnosed With Sore Throat Pain Phase 3
Completed NCT04016051 - Acceptance of Clarithromycin in a Straw Compared to Syrup in Children With Upper Respiratory Tract Infections Phase 3
Recruiting NCT01681667 - Tablet vs. Liquid Suspension Ibuprofen in the Relief of Pain Phase 4
Completed NCT00527852 - Assessment of Flocked Swabs for the Identification of Group A Streptococcal Pharyngitis N/A
Completed NCT02178293 - Ketoprofen Lysine Salt as Mouthwash in Acute Phlogosis of the Pharyngeal Cavity Versus Benzidamine Hydrochloride Phase 4
Active, not recruiting NCT05127161 - Broad Implementation of Outpatient Stewardship N/A
Withdrawn NCT02535962 - Probiotics and Corticosteroids for Treating Periodic Fever, Aphthous Stomatitis, Pharyngitis, Cervical Adenitis (PFAPA) Phase 2
Not yet recruiting NCT02252419 - Combined Effect of Dexamethasone and Paracetamol for Postoperative Sore Throat N/A
Completed NCT00798018 - Effect of Intra-cuff Lidocaine and Tetracaine on Tracheal Tube-induced Emergence Phenomena N/A
Completed NCT00535093 - An Assessment of Rapid Streptococcal Tests in Community Clinics in Israel N/A
Completed NCT00148499 - Efficacy and Tolerability of Ambroxol Lozenge 20 mf in Relieving Pain of Sore Throat in Pat. With Acute/Viralpharyngitis Phase 3
Completed NCT00095368 - APC-111 Once a Day (QD) for 7 Days vs. Penicillin Taken Four Times a Day (QID) for 10 Days in Patients With Strep Throat Phase 3
Recruiting NCT06027593 - Using Electronically Derived Automated Reports of Appropriate Antibiotic Use to Inform Stewardship Interventions N/A
Recruiting NCT03720301 - The Use of Osteopathic Medical Manipulation to Decrease the Incidence and Severity of Post-Operative Sore Throat N/A
Completed NCT01361399 - Active and Placebo Controlled Study to Test the Efficacy and Safety of an Aspirin-Lidocaine Lozenge in the Symptomatic Treatment of Sore Throat Associated With a Common Cold Phase 3
Completed NCT01049334 - A Study of Flurbiprofen 8.75 mg Lozenge in Patient With Pharyngitis Phase 3
Completed NCT01398696 - Impact of Four Patient Information Leaflets (PIL) on Patient Behaviour Phase 4
Completed NCT01048866 - A Study of Flurbiprofen 8.75 mg Lozenge in Patients With Pharyngitis Phase 3
Completed NCT00547391 - Recurrent Throat Infections and Tonsillectomy Phase 4
Completed NCT00242281 - APC-111 MP Tablet Once a Day vs.Penicillin VK Four Times a Day Both for 10 Days in Patients With Strep Throat Phase 3