EUCTR2011-005848-10-GB进行中（未招募）不适用
Analgesic profile of 3 new Ibuprofen lozenges (V0498TA01A 15mg, 25mg,35mg) after single administration in acute sore throat pain
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 185
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- 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
排除标准
- •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 medica
研究者
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