Analgesic profile of 3 new Ibuprofen lozenges (V0498TA01A 15mg, 25mg,35mg) after single administration in acute sore throat pai

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 185

Inclusion Criteria

- Male or female patients 18 years and older.
- patients with a sore throat associated or not with an URTI = 24 hours and < or = 5 days duration, in the absence of Streptococcus group A. as confirmed by a swab test before randomisation
- patients with tonsillopharyngitis = 6 on 21-point TPA (Tonsillo Pharyngitis Assessment) scale.
- patients with a Sore Throat Intensity Scale assessed by VAS more than or equal to 60 mm.
- For female patients of child-bearing potential:
- Negative urinary pregnancy test.
- Use of an effective contraceptive method (oral contraception, surgical method, intra-uterine device or diaphragm) during the study and at least one week after the study end visit or
- Agreements to have her male partner(s) use a condom during each
sexual intercourse during the study and at least one week after the
study end visit.
- patients 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).
- patients having signed a written informed consent.
- patients affiliated to a social security system or are beneficiaries.
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 120
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 65

Exclusion Criteria

Related to pathologies
- patients with pharyngeal paresthesia.
- patients with pharyngeal mycosis.
- patients with known peritonsillar abscess.
- patients with hyposialia or asialia, any swallowing disorder.
- patients with any painful condition that may have distracted attention from sore throat pain, (e.g. mouth ulcers).
- patients with any disease that could compromise breathing such as bronchospasm or severe/instable asthma.
- patients with evidence of mouth-breathing or uncomfortable coughing.
- patients with a history of an upper gastrointestinal ulcer within the past 30 days, who are currently experiencing clinically significant upper gastrointestinal complaints, or are currently taking medication regularly (= 3 times in the previous week).
- patients with Crohn's disease or ulcerative colitis.
- patients with a severe renal impairment.
- patients with history of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy.
- patients with gastrointestinal bleeding or cerebrovascular hemorrhage or other hemorrhage.
- patients with severe heart failure.
- patients with severe hepatic failure.
- patients with disseminated erythematous lupus.
- patients with glucose and galactose malabsorption syndrom,fructose intolerance, or sucrase-isomaltase deficiency.

Related to treatments
- patients with known history of Ibuprofen or other NSAID-induced bronchospasm.
- patients with a long term use of anti-inflammatory drugs.
- patients with a long term use of anticoagulants or antiplatelet agents.
- patients with hypersensitivity to Ibuprofen or other NSAIDs or the excipients.
- patients having used analgesics within 6 hours before study entry and who use analgesics more than = 3 times per week.
- patients having used any long-acting or slow release analgesics within 12 hours before study entry (e.g. piroxicam or naproxen).
- patients having used any anti inflammatory treatment within 12 hours before study entry.
- patients having used any antiseptics 6 hours before study entry.
- patients having used any local medication containing a local oral anaesthetic such as lozenge, spray, mouth rinse within 6 hours before study entry.
- patients having used any topical throat treatment within 6 hours before
study entry.
- patients having taken antibiotics within 14 days before study entry.
- patients having been treated with anticholinergic drugs, atropine, scopolamine, quaternary ammoniums, imipraminic antidepressives, phenothiazines neuroleptics, disopyramide, antimitotic drugs which influence salivary flow within 14 days before study entry.
- patients with history of disgust for mint, peppermint, menthol.

Related to population
- patients with a history of alcohol abuse.
- patients unable to refrain from smoking during their stay in the investigative site.
- 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 nursing-mother
- patient who is participating in or is in the exclusion period of another
clinical trial
- patients 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.
- patients who has forfeited their freedom by administrative or legal award, or who is under guardianship.
- patients who do not want to accept during the first 2H of the study, not
to take other medications, suck other lozenges, use toothpaste, mout

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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