Ibuprofen lozenge for Pain in Acute Sore Throats

• Conditions: Acute Sore Throat Pain; MedDRA version: 14.1Level: PTClassification code 10049140Term: PharyngotonsillitisSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2012-004423-20-GB
• Lead Sponsor: Centre de Recherche et Développement Pierre Fabre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11-30
• Last Update Posted: 10 March 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 382

Inclusion Criteria

- male or female aged at least 18 years old
- patient with an acute sore throat:
- of recent onset (within the last 72 hours)
- associated or not with an upper respiratory tract infection (URTI)
- in the absence of Streptococcus group A (negative Streptococcal swab test before randomisation)
- Tonsillo-Pharyngitis Assessment scale (TPA) = 5 on a 21- point scale
- Sore Throat Pain Intensity when swallowing (STPIS) = 60 mm on a 100 mm visual analogue scale (VAS)
- for female patient with child-bearing potential: negative urinary pregnancy test
- patient able to understand and to comply with all study procedures (e.g. such as those who could understand correctly the use of the pain rating scales)
- patient having signed a written informed consent

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 260
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 122

Exclusion Criteria

Related to pathologies:
- severe respiratory tract infection (pneumonia, bronchitis or laryngitis)
- oro-pharyngeal paresthesia or mycosis
- severely traumatised and/or very severe oromucosal inflammation
- tonsillopharyngectomy
- Peritonsillar abscess
- hyposalivation or asialia, or any swallowing disorder other than linked to sore throat.
- any painful condition that may have distracted attention from sore throat pain, (e.g. mouth ulcers)
- any disease that could compromise breathing such as bronchospasm or severe/instable asthma
- mouth-breathing or uncomfortable coughing
- history of an upper gastrointestinal ulcer within the past 30 days before randomisation
- Crohn’s disease or ulcerative colitis
- history of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy.
- known cerebrovascular haemorrhage or other haemorrhage disease
- severe heart failure
- severe renal impairment
- severe hepatic failure
- disseminated erythematous lupus

Related to treatments:
- 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
- any product with demulcent properties within 2 hours before randomisation
- any antibiotics intake by systemic route within 7 days before randomisation
- any intake of anticoagulants or antiplatelet agents within 14 days before randomisation
- any intake of anticholinergic drugs, atropine, scopolamine, quaternary ammoniums, imipraminic antidepressives, phenothiazines, neuroleptics, disopyramide or antimitotic drugs which influence salivary flow within 14 days before randomisation

Related to population:
- heavy smokers (>20 cigarettes/day)
- history of alcohol abuse
- patient who is a family member or work associate (secretary, nurse, technician ..) of the investigator
- female patient who is in post-partum period or a breast-feeding mother
- patient who is participating in or is in the exclusion period of another clinical trial
- patient mentally unable in the opinion of the investigator to understand the nature and the objectives of the study and unable to comply fully with the study requirements
- patient who has forfeited his freedom by administrative or legal award, or who is under guardianship
- patient who does not accept not to take any medications or OTC drugs during the 1 hour before and the 2 hours after the start of sucking of the 1st study drug administered
- patient who does not accept not to eat or not to drink or not to smoke during the 1 hour before and the 2 hours after the start of sucking of the 1st study drug administered
- patient who does not accept not to smoke or not to eat or not to drink at least 1 hour before each assessment timepoint
- pregnancy

Study & Design

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