EUCTR2015-004077-32-Outside-EU/EEA进行中（未招募）不适用
A randomized open-label, multinational, multicentre, phase III clinical study to evaluate the efficacy and safety of Ibuprofen oral suspension 20 mg/ml and Ibuprofen oral suspension 40 mg/ml (Berlin-Chemie) compared with Nurofen® oral suspension 20 mg/ml (Reckitt Benckiser) in children 3-9 years old with uncomplicated acute otitis media - not available
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
- 135
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
- •1)Child’s parents’ written informed consent for the child’s participation in the study.
- •2)Boys and girls 3 to 9 years old inclusive.
- •3)Body weight 10 – 29 kg inclusive.
- •4)Established diagnosis of AOM, either unilateral or bilateral, following diagnosis criteria:
- •a)Presence of uni- or bilateral otalgia (pain rating scale score = 4);
- •b)Recent onset of signs and symptoms including ear pain (within 48 hours);
- •c)Presence of erythema or fullness or bugling of the tympanic membrane (assessed by otoscopy).
- •5)Fever = 37.5 º? at screening.
- •6)Indications for oral antibiotics administration.
- •7)Parent(s) is(are) able to complete the study protocol (e.g. filling the Diary, assessing ear pain by pain scales) and has(-ve) access to telephone contacts.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 135
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1)Known or suspected hypersensitivity to the ibuprofen or to any of the excipients of study drugs, including fructose intolerance.
- •2)Known or suspected hypersensitivity to antibiotics (penicillines, cephalosporines, carbapenems).
- •3)History of bronchospasm, asthma, rhinitis, angioedema or urticaria associated with the intake of acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs).
- •4)Previous treatment of the current AOM:
- •a)any systemic antibiotic treatment at screening and at least 3 days before screening.
- •b)any systemic and/or topical analgesics for AOM at screening and within previous 24 hours.
- •c)previous invasive treatment of current AOM.
- •5)Severe fever at screening (> 40 °C)
- •6)Patients requiring non-oral administration of antibiotics.
- •7)Recurrent AOM (clinical recurrence of AOM within 30 days or history of more than 4 episodes of AOM over the course of 12 months).
- •8)Presence of otogenic complications of AOM (such as mastoiditis, labyrintitis etc.) or spontaneous perforation of the tympanic membrane.
- •9)Known presence of complications of the upper respiratory tract infections such as sinusitis (including catarrhal sinusitis) or pneumonia.
- •10)Known presence of AOM underlying chronic otitis media.
- •11)Presence of cochlear implants or prior middle ear surgery (e.g., tympanostomy tube[s] in place or a history of tympanostomy tubes).
- •12)Patients who underwent ear surgery such as canal wall down, mastoidectomy or tympanoplasty less than a year ago.
- •13)Any form of coagulation disturbances (e.g. hemophilia) or any active bleeding.
- •14)History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy.
- •15)Underlying systemic problems that might obscure response to infection, e.g., serious underlying disease (cystic fibrosis, neoplasm, juvenile diabetes, HIV-infection).
- •16)Presence of immunodeficiency or receipt of immunosuppressive therapy.
- •17)Concomitant active infection other than AOM or acute respiratory illness.
- •18)Known presence of severe hepatic failure (AST, ALT more than 3 times the upper value of the reference range).
- •19)Known presence of severe renal failure (creatinine clearance < 30 ml/min).
- •20)Chronic gastrointestinal conditions (i.e., malabsorption, inflammatory bowel disease).
- •21)Severe dehydration (caused by vomiting, diarrhoea or insufficient fluid intake).
- •22)Congenital disorder of porphyrin metabolism (e.g. acute intermittent porphyria)
- •23)Otologic or craniofacial abnormalities (e.g. unrepaired or repaired overt or submucous cleft palate, high-arched palate), or Down's syndrome.
- •24)Children, who cannot cooperate, comprehend or use the Pain rating scale.
- •25)The patient requires or may require medications prohibited by the protocol (e.g. ear drops, other NSAIDs and analgesics, systemic corticosteroids, anti-coagulants, CYP2C9 inhibitors, phenylbutazone, oxyphenbutazone, methotrexate and other medications that may interact with study drugs).
- •26)Participation in another clinical study within previous 30 days.
研究者
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