EUCTR2015-003947-21-PL
Active, not recruiting
Phase 1
’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’’
FARMAKA Srl0 sites180 target enrollmentNovember 17, 2015
Conditionsmoderate or severe sore throatTherapeutic area: Diseases [C] - Ear, nose and throat diseases [C09]
DrugsDicklofenac spray
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- moderate or severe sore throat
- Sponsor
- FARMAKA Srl
- Enrollment
- 180
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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.
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
- •?Bronchopneumonia
Outcomes
Primary Outcomes
Not specified
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