A Phase 4 interventional study of Benzalkonium Chloride-Benzocaine Topical and Placebo Oral Tablet in Pharyngitis, sponsored by Medice Arzneimittel Pütter GmbH & Co KG. Completed at 1 site in Germany. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2017-11-28.
Sponsored by Medice Arzneimittel Pütter GmbH & Co KG · Phase 4, Interventional, and Treatment
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.
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.
226 studies on the registry are indexed under Pharyngitis; 35 are open to participants now.
This study's enrollment of 321 is above the median of 144 across 188 interventional studies indexed under Pharyngitis.
Browse Pharyngitis studies →Medice Arzneimittel Pütter GmbH & Co KG is the lead sponsor of 10 studies on the registry; none are open to participants now.
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Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Dorithricin throat lozenges is a fixed combination of three active substances: Benzalkonium Chloride-Benzocaine Topical plus tyrothricin. Lozenge has to be sucked slowly until it fully dissolves in the mouth and dosed up to 8 lozenges per day. Test product without mint oil. Intervention: The initial dose is administered at the study site. Patients administer at home 1 lozenge at intervals of 2 hours (±15 minutes) up to a maximum of 8 lozenges per day.
Drug: Benzalkonium Chloride-Benzocaine Topical
Placebo Oral Tablet is taken orally. Placebo consists of a lozenge with matched appearance and the same excipients as those of the Dorithricin lozenge. The initial dose (2 lozenges simultaneously) is administered at the study site. Intervention: Patients are instructed to administer at home 1 lozenge at intervals of 2 hours (±15 minutes) up to a maximum of 8 lozenges per day.
Drug: Placebo Oral Tablet
Dorithricin = tyrothricin, benzalkonium chloride, benzocaine
Also known as: triple combination
Placebo Oral Tablet = a lozenge with matched appearance and the same excipients as Active Comparator Dorithricin lozenge. Intervention: Patients are instructed to administer at home 1 lozenge at intervals of 2 hours (±15 minutes) up to a maximum of 8 lozenges per day.
Also known as: Placebo lozenge
percentage of total responders assessed at Visit 2 (72 hours after first treatment)
complete resolution of throat pain and difficulty in swallowing at Visit 2
Time frame: 72 hours after first treatment
percentage of total responders assessed after 48 hours after first treatment
complete resolution of throat pain and difficulty in swallowing after 48 hours after first treatment
Time frame: 48 hours after first treatment
percentage of patients with complete resolution of throat pain 72 hours after first treatment
complete resolution of throat pain after 72 hours after first treatment
Time frame: 72 hours after first treatment
percentage of patients with complete resolution of difficulty in swallowing 72 hours after first treatment
complete resolution of difficulty in swallowing after 72 hours after first treatment
Time frame: 72 hours after first treatment
Plan to share: No — study protocol, statistical analysis plan, informed consent form, clinical study report are shared with all 26 recruited centers of the DoriPha investigators
Ran from Feb 2017 to primary completion in Jul 2017, 5 months.
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Medice Arzneimittel Pütter GmbH & Co KG