STUDY OF EFFICACY AND SAFETY OF V0498 VERSUS PLACEBO IN ACUTE SORE THROAT PAI

Phase 1

• Conditions: Acute sore throat; MedDRA version: 16.0 Level: PT Classification code 10049140 Term: Pharyngotonsillitis System Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2012-004423-20-FR
• Lead Sponsor: PIERRE FABRE MEDICAMENT

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-06-19
• Study Completion: 2013-06-25
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 292

Inclusion Criteria

- male or female aged at least 18 years old
- patient with an acute sore throat

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 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 92

Exclusion Criteria

- Severe respiratory tract infection (pneumonia, bronchitis or laryngitis)
- Oro-pharyngeal paresthesia or mycosis
- Severely traumatised and/or very severe oromucosal inflammation
- Tonsillopharyngectomy
- Peritonsillar abscess
- Hypersensitivity to ibuprofen or other NSAIDs (including bronchospasm) or to excipients
- Long term use (= 3 times per week within the last month or regular intake within the last 3 months before randomisation) of anti-inflammatory drugs
- Any long-acting or slow release analgesic intake including NSAIDs within 24 hours before randomisation (e.g. piroxicam or naproxen)
- Any anti-inflammatory drugs intake by systemic route within 12 hours before randomisation
- Any paracetamol intake within 6 hours before randomisation
- Any cold medication (decongestant, antihistamine, expectorant, antitussive) within 6 hours before randomisation
- Any topical throat medication intake containing or not a local oral anaesthetic such as lozenge, spray, mouth rinse within 4 hours before randomisation
- Heavy smokers (>20 cigarettes/day)

Study & Design

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