’Dose dependent pain relieving efficacy and local tolerability of diclofenac oromucosal spray in the treatment of sore throat: A multicenter, parallel-group, double-blind, placebo controlled and randomized clinical study’’

Phase 1

• Conditions: moderate or severe sore throat; Therapeutic area: Diseases [C] - Ear, nose and throat diseases [C09]

• Registration Number: EUCTR2015-003947-21-PL
• Lead Sponsor: FARMAKA Srl

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-11-17
• Last Update Posted: 4 May 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

?Male or female outpatients
?Aged 18 – 75 years
?Evidence of acute viral tonsillopharyngitis not requiring antibiotic treatment as diagnosed by physician
?Pain at swallowing (odynophagia) not less than 50 mm on a 100 mm VAS scale
?Tonsillo-Pharyngitis Score (TPS) >6 points at baseline.
?Disease onset within 48 hours prior to study inclusion, medically untreated.
?If female of childbearing potential:
?Have maintained reliable birth control (oral contraceptive, IUDs ) for at least one month before the enrollment and agree to maintain it throughout the study and
?with negative pregnancy test (urine)
?Subject who, in the opinion of the investigator, would understand the meaning of the information sheet, would be co-operative and sufficiently reliable to use the medication as instructed, complete the diary and return for scheduled visits including assurance of availability for follow¬-up call.
?Subject has provided signed written informed consent

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 180
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 180

Exclusion Criteria

?Known hypersensitivity to any component of the study medication and / or paracetamol
?Hypersensivity to acetylsalicylic acid and any NSAIDs
?Recognized alteration in hepatic or renal function or positive history of gastrointestinal disorders
?Recognized glucose 6 dehydrogenase deficit
?Streptococcal throat infection - positive finding on Strep Test in commercial presentation available on the Polish market
?Subject undergone to any oromucosal surgery 30 days before the enrollment date
?Subject mentally not capable of adhering to the protocol
?Subjects suffering from depression, epilepsy or other psychological disorders
?Known impaired kidney, liver or lung function
?Asthma
?Bronchopneumonia
?Sore throat had been present for more than 2 days
?Cardiac malfunction
?Hypertension: Diastolic Blood Pressure >90 mm Hg or Systolic Blood Pressure >140 mm Hg unless stable and under adequate therapy
?Hypotension: Systolic Blood pressure < 100 mm Hg
?Bradycardia: frequency < 45 beats / min
?Gastrointestinal disorders, especially ulcers and acute or chronic gastritis
?Malignant disease
?Pathological changes (open wounds) in oral cavity
?Suspected peritonsillar abscess
?Use of any pastille, lozenge, spray or topical medication containing local anesthetic, disinfectant or anti-inflammatory within 15 hours prior to study entry (5 x elimination half-life)
?Use of any long-acting or slow-release analgesic, including NSAIDs, within 24 hours of study entry
?Pregnant or lactating women
?Women of childbearing potential who are not taking adequate contraception
?The patient is not able to fully comply with trial requirements
?Participation in any other clinical trial within the previous 30 days
?Drug addiction
?Nicotine: more than 20 cigarettes per day, (smoking is prohibited during the first hour after the application of the IMP / placebo)
?Alcohol abuse(no alcohol intake during the study!!!)
?Known positive HIV-infection

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified