Analgesic profile of 3 new Ibuprofen lozenges (V0498TA01A 15mg, 25mg, 35mg) after single administration in acute sore throat pai
- Conditions
- Acute sore throatMedDRA version: 14.1 Level: PT Classification code 10049140 Term: Pharyngotonsillitis System Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2011-005848-10-FR
- Lead Sponsor
- PIERRE FABRE MEDICAMENT
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 185
- 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
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.
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
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