Benzydamine in Sore Throat Pain Relief (BePaiR Study)

• Status: Completed
• Trial end date: 2021-06-30
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this study is to generate new clinical data about the speed of relief provided by a single application of Benzydamine hydrochloride 0,3% oromucosal spray vs Benzydamine hydrochloride 3 mg lozenges mint flavour.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aziende Chimiche Riunite Angelini Francesco S.p.A
• Collaborator: Zak-Pharma Dienstleistung Ges.m.b.H.
• Treatments: Benzydamine

Criteria

Inclusion Criteria:

• Adult male and female patients (aged 18 - 75 years, limits included) with recent onset (≤3 days) of sore throat and a diagnosis of tonsillopharyngitis confirmed by:

1. Presence of at least one symptom of URTI in the previous 24 h on the URTI questionnaire;

2. Sore throat pain intensity score ≥ 60 mm on Sore Throat Pain Intensity Scale (STPIS);

3. A score ≥ 5 on Tonsillo-Pharingytis Assessment (TPA);

• Women of childbearing potential or with no menses for a period < 12 months must have a negative pregnancy test at Visit 0 and have to agree not to start a pregnancy from the signature of the informed consent up to the Visit 2, using an appropriate birth control method such as combined oestrogen-progestin containing hormonal contraceptives (e.g., oral, injectable, transdermal), progestin-only hormonal contraceptives (e.g., oral, injectable, implantable), intrauterine device (IUD) or Intrauterine hormone-releasing System (IUS) in combination with male condom, bilateral tubal occlusion, vasectomised partner, sexual abstinence. The following definitions will be considered:

• Woman of childbearing potential (WOCBP): i.e., fertile, following menarche and until becoming post-menopausal, unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy.

• Patients legally capable of giving their consent to participate in the study (including personal data processing) and available to sign and date the written informed consent.

Exclusion Criteria:

• Known hypersensitivity to benzydamine or its excipients;

• Phenylketonuria;

• Clinically significant abnormalities at physical examination and vital signs;

• Intolerance to acetylsalicylic acid or other NSAIDS;

• History or diagnosis of asthma;

• Any concomitant disease that compromise breathing (i.e. bronchopneumonia);

• Mouth breathing due to nasal congestion which causes throat drying;

• Severe coughing which causes throat discomfort;

• Purulent plaques on the tonsils;

• Any inhaled therapy in the previous week before the first drug administration;

• Use of antibiotics for an acute disease in the 7 days before randomisation (chronic antibiotic use, such as for acne, is acceptable); any sustained release analgesic within 24 hours of administration of study medication; any medications for cold and flu (i.e., decongestants, antihistamines, expectorants, antitussives), immediate release analgesic or antipyretic within 4 hours of administration of study medication;

• Use of any lozenge, mouthwash, spray or menthol-containing products within 2 hours of administration of study medication;

• Women during pregnancy or lactation period;

• Subject involved in the conduct of the study (e.g. Investigator or his/her deputy, first grade relatives, pharmacist, assistant or other personnel, etc);

• Participation to a clinical trial within 3 months prior to the inclusion in the study.