EUCTR2014-004164-38-Outside-EU/EEA进行中（未招募）不适用
An Open Label, Randomized, Single Dose, Parallel Arm Study To Determine Pharmacokinetics Of Azithromycin Following Oral Administration Of Immediate-Release (IR) Or Extended-Release (ER) Formulation In Pediatric Subjects With Acute Otitis Media (AOM)
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Pfizer Inc
- 入组人数
- 38
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. Male or female pediatric subjects age 6 months to 6 years old inclusive.
- •2. For each subject, the parent(s) or legal guardian(s) must be willing and able to provide written informed consent. Where appropriate, the assent of the subject will also be obtained. Subject’s age and relationship to the parent(s) or legal guardian(s) must be verified and documented.
- •3. Have clinical signs or symptoms of acute otitis media in at least one ear as follows:
- •Purulent otorrhea of less than or equal to (=) 24 hours duration
- •At least 2 otoscopic signs of middle ear effusion
- •Decreased or absent tympanic membrane mobility by pneumatic otoscopy
- •Yellow or white discoloration of tympanic membrane
- •Opacification of tympanic membrane (other than scarring)
- •4. At least 1 indicator of acute inflammation to support the diagnosis of AOM:
- •Ear pain, including unaccustomed tugging or rubbing
- •Marked redness of tympanic membrane
- •Distinct fullness or bulging of tympanic membrane
- •5. Subjects may be inpatients or outpatients. Subjects or their parent(s) or guardian(s) who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 38
- •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 38
排除标准
- •1. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) disease or clinical findings at screening.
- •2. Inability to take oral medications or any condition possibly affecting drug absorption.
- •3. Treatment with an investigational drug within 30 days or 5 half-lives preceding the first dose of study medication.
- •4. Previously diagnosed disease(s) of immune function.
- •5. Known or suspected hypersensitivity, or intolerance to azithromycin or other
- •macrolides or to any penicillin, beta-lactam antibiotic or beta lactamase inhibitor.
- •6. Use of prescription or non-prescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication.
- •7. Any medical condition that could interfere with the evaluation of the study drug and would make the subject unsuitable for enrollment, including: Tympanostomy tubes in place, Otitis externa, evidence of chronic middle ear disease including retraction pockets, cholesteatoma and erforations of the tympanic membrane in the affected ear for less than 24 hours prior to study entry or Mastoiditis.
- •8. Subjects who have consumed grapefruit or grapefruit containing products within 7 days prior to the dose of study medication, or intending to consume these products during the study.
- •9. Unwilling or unable to comply with the Life Style Guidelines described in the Protocol of the study.
- •10. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
研究者
相似试验
已完成
2 期
A Clinical Trial to evaluate the Efficacy and Safety of Intravenous Infusion of Nanosomal Paclitaxel Lipid Suspension and Taxol in Metastatic Breast cancer patients.CTRI/2010/091/001344Intas Pharmaceuticals Ltd120
已完成
2 期
A Clinical Study to evaluate the Effectiveness and Safety of Intravenous Infusion of Nanosomal Paclitaxel Lipid Suspension in comparison with Taxol in Breast cancer patients.CTRI/2015/07/006062Intas Pharmaceuticals Ltd54
已完成
2 期
A Clinical trial of Infusion of Nanosomal Docetaxel Lipid Suspension and Taxotere® in Breast Cancer PatientsCTRI/2010/091/000610Intas Pharmaceuticals Limited72
进行中（未招募）
不适用
Investigation of the ability of MRI to show changes in the nose after treatment of patients with Vicks® Sinex® Micromist®EUCTR2011-002443-10-GBProcter & Gamble Technical Centres Ltd., UK20
已完成
Unknown
Phase 1 study to evaluate the safety and pharmacokinetics comparison of AD-104 in healthy adult volunteersKCT0009332Addpharma40