moderate or severe sore throat
Conditions
Interventions
Trade Name: Dicklofenac spray
Product Name: diclofenac spray
Pharmaceutical Form: Oromucosal spray
Pharmaceutical form of the placebo: Oromucosal spray
Route of administration of the placebo: Oromucos
Sponsors
FARMAKA Srl
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the analgesic efficacy of diclofenac oromucosal spray 1.48 mg/ml in single and repeated administrations in two parallel groups of two different daily diclofenac doses compared to placebo group in the treatment of sore throat;Secondary Objective: To evaluate local safety and tolerability profile of IMP in the treatment of sore throat To evaluate the pain relieving efficacy of IMP in comparison to placebo. To examine the time course of symptom improvement due to the treatment with IMP To examine the influence of baseline characteristics and consumption of rescue medication on treatment outcome. ;Primary end point(s): Primary Efficacy Variable: ? Change of intensity of spontaneous pain (pharyngodynia) and pain upon swallowing (odynophagia) between baseline value (day0 before the first dose) and within one hour after the first application of the IMP, assessed by the patient using VAS scale, AUC between baseline measurement and hour 1. Secondary Efficacy Variables: ? Change of intensity of spontaneous pain (pharyngodynia) and pain upon swallowing (odynophagia) between baseline value (day0 before the first dose) and within one hour after the first application of the IMP, assessed by the patient using 5-point categorical scale, AUC between baseline measurement and hour 1. ? Change of intensity of spontaneous pain (pharyngodynia) and pain upon swallowing (odynophagia)assessed by the patient every day, one hour after the morning and evening dose, using VAS scale, AUC between baseline and day 7. ? Change of intensity of spontaneous pain (pharyngodynia) and pain upon swallowing (odynophagia) assessed by the patient every day, one hour after the morning and evening dose, using 4-point categorical scale, AUC between baseline and day 7. ? Pain Intensity Difference (PID) ? Summed PID (SPID) ? Summed PI (SPI) ? Pain Relief and PID (PRID) ? Summed PRID (SPRID) ? Total Pain Relief (TOTPAR) ? Time to Perceptible Pain Relief (PPR) and Meaningful | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Primary Efficacy Variable: ? Change of intensity of spontaneous pain (pharyngodynia) and pain upon swallowing (odynophagia) between baseline value (day0 before the first dose) and within one hour after the first application of the IMP, assessed by the patient using VAS scale, AUC between baseline measurement and hour 1. Secondary Efficacy Variables: ? Change of intensity of spontaneous pain (pharyngodynia) and pain upon swallowing (odynophagia) between baseline value (day0 before the first dose) and within one hour after the first application of the IMP, assessed by the patient using 5-point categorical scale, AUC between baseline measurement and hour 1. ? Change of intensity of spontaneous pain (pharyngodynia) and pain upon swallowing (odynophagia)assessed by the patient every day, one hour after the morning and evening dose, using VAS scale, AUC between baseline and day 7. ? Change of intensity of spontaneous pain (pharyngodynia) and pain upon swallowing (odynophagia) assessed by the patient every day, one hour after the morning and evening dose, using 4-point categorical scale, AUC between baseline and day 7. ? Pain Intensity Difference (PID) ? Summed PID (SPID) ? Summed PI (SPI) ? Pain Relief and PID (PRID) ? Summed PRID (SPRID) ? Total Pain Relief (TOTPAR) ? Time to Perceptible Pain Relief (PPR) and Meaningful Pain Relief (MPR) ? Time to Onset of Analgesia ? Global assessment by the patient. ? Global assessment by the investigator. Safety will be assessed using adverse events and vital signs. | — |
Countries
Poland
Contacts
Public ContactDariusz Wilkowski
Angelini Pharma Polska Sp. z o.o.
Outcome results
None listed