Benzydamine in Sore Throat Pain Relief (BePaiR Study)

NCT ID: NCT04941976

Last Updated: 2021-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 356 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-13
• Study Completion Date: 2021-06-30

Brief 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.

Detailed Description

The efficacy and safety of benzydamine local-applied, in the treatment of various throat inflammatory and painful conditions, had been widely demonstrated.

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 or Benzydamine hydrochloride 3 mg lozenges mint flavour.

The study will be conducted at 15 sites located among Poland, Hungary and Russia (5 sites for each country).

356 patients affected by acute sore throat will be enrolled in out-patient clinics or out-patient departments of city hospitals.

Conditions

Acute Sore Throat

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

0.3% benzydamine hydrochloride spray oromucosal solution

A single application of 0.3% benzydamine hydrochloride spray oromucosal solution, corresponding to 2.04 mg of benzydamine (4 nebulizations)

Group Type: EXPERIMENTAL

0.3% benzydamine hydrochloride spray oromucosal solution

Intervention Type: DRUG

Single application of 0.3% benzydamine hydrochloride spray oromucosal solution. Drug applications will be performed at the investigational site, on the morning of Visit 0.

In case of persistent sore throat patients will continue the assigned treatment at home, according to the local SmPC and up to one week, until the symptoms' resolution.

3 mg lozenge of benzydamine hydrochloride (mint flavour), corresponding to 2.68 mg of benzydamine

A single 3 mg lozenge of benzydamine hydrochloride (mint flavour), corresponding to 2.68 mg of benzydamine.

Group Type: ACTIVE_COMPARATOR

Single 3 mg lozenge of benzydamine hydrochloride (mint flavour)

Intervention Type: DRUG

Single 3 mg lozenge of benzydamine hydrochloride (mint flavour). Drug applications will be performed at the investigational site, on the morning of Visit 0.

In case of persistent sore throat patients will continue the assigned treatment at home, according to the local SmPC and up to one week, until the symptoms' resolution.

Interventions

0.3% benzydamine hydrochloride spray oromucosal solution

Single application of 0.3% benzydamine hydrochloride spray oromucosal solution. Drug applications will be performed at the investigational site, on the morning of Visit 0.

In case of persistent sore throat patients will continue the assigned treatment at home, according to the local SmPC and up to one week, until the symptoms' resolution.

Intervention Type: DRUG

Single 3 mg lozenge of benzydamine hydrochloride (mint flavour)

Single 3 mg lozenge of benzydamine hydrochloride (mint flavour). Drug applications will be performed at the investigational site, on the morning of Visit 0.

In case of persistent sore throat patients will continue the assigned treatment at home, according to the local SmPC and up to one week, until the symptoms' resolution.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zak-Pharma Dienstleistung Ges.m.b.H.

UNKNOWN

Sponsor Role: collaborator

Aziende Chimiche Riunite Angelini Francesco S.p.A

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Háziorvosi Rendelő

Budapest, , Hungary

Háziorvosi Rendelő

Budapest, , Hungary

Háziorvosi Rendelő

Érd, , Hungary

Háziorvosi Rendelő

Pilisvörösvár, , Hungary

Háziorvosi Rendelő

Tárnok, , Hungary

NZOZ Centrum Zdrowia i Profilaktyki Dabie Filia

Krakow, , Poland

NZOZ Centrum Zdrowia i Profilaktyki Dabie Krakow

Krakow, , Poland

ValeoMedical

Lodz, , Poland

Zdrowa Rodzina Przychodnia Lekarska

Warsaw, , Poland

Przchodnia Orlik

Warsaw, , Poland

Scientific research center Eco-Safety, LLC

Saint Petersburg, , Russia

Scientific research center Eco-Safety, LLC

Saint Petersburg, , Russia

Private Healthcare Institution "Clinical Hospital "RZD-Medicine" St.Petersburg"

Saint Petersburg, , Russia

Saint-Petersburg State Budgetary Healthcare Institution "City outpatient clinic #106"

Saint Petersburg, , Russia

Hospital "OrKli" LLC

Saint Petersburg, , Russia

"Astarta" LLC

Saint Petersburg, , Russia

"Meili" LLC

Saint Petersburg, , Russia

Countries

Hungary; Poland; Russia

Other Identifiers

2019-003257-29

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

030(Z)WO19176

Identifier Type: -

Identifier Source: org_study_id