PER-046-00已完成未知
DOUBLE BLIND RANDOMIZED MULTICENTRIC PARALLEL GROUP STUDY TO COMPARE MONTELUKAST WITH PLACEBO IN PEDIATRIC PATIENTS OF 6 TO 24 MONTHS OF AGE WHO HAVE ASTHMA
MERCK SHARP & DOHME PERU S.R.L.,0 个研究点目标入组 0 人开始时间: 2000年8月8日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 至 0（—）
入选标准
- •The patient is male or female and is between> 6 months and <24 months of age.
- •The patient is in the 5th to 95th percentile for height and weight by age
- •The parent / legal guardian accepts the patient´s participation in the study as indicated by the signature of the parent / legal guardian on the consent form. The parent / guardian is willing to comply with the procedures and both the patient and the parent / guardian may make the scheduled clinical visits.
- •It is considered that the patient is otherwise in good physical condition according to the medical history, the physical examination and the usual laboratory information.
- •The patient has received solid food for at least 1 month.
- •The patient has received applesauce or another product containing apple for at least 1 week before the Pre-study Visit (Visit 1).
- •Parents / guardians can read and understand the asthma calendar.
- •The patient has experienced at least 3 episodes of asthma or asthma-like symptoms (including, but not limited to, coughing, wheezing and shortness of breath), all of which occurred 8 weeks after birth and before the Visit Pre-study (Visit 1).
- •The patient has symptoms that agree, at least, with the asthma classified in Step 2 of the GINA guidelines as demonstrated by the response that the parent / guardian provides in letter b for the 2 questions of the Baseline Questionnaire of Asthma.
排除标准
- •In the opinion of the investigator, the parent / guardian is mentally or legally incapacitated, which prevents the obtaining of informed consent.
- •The patient is hospitalized.
- •The patient has participated in a clinical trial that involves a drug or vaccine under investigation or commercialized within 8 weeks of the Pre-study visit.
- •The patient has undergone some important surgical procedure within 4 weeks of the Pre-study visit.
- •The patient is allergic to apples or applesauce.
- •The patient was born prematurely (that is, less than 28 weeks of gestation).
- •The patient has some active, acute or chronic lung disease, apart from asthma, documented by his history or a physical examination.
- •The patient has required intubation for asthma in the past.
- •The patient has had to go to an emergency due to an asthma exacerbation or has been hospitalized for asthma within 2 weeks of the Pre-study visit.
- •The patient has unresolved signs and symptoms of an upper or lower respiratory tract infection in the Pre-study Visit.
- •General Practitioners
- •The patient has a history of any of the following medical conditions; cystic fibrosis, tuberculosis, foreign body aspiration, bronchopulmonary dysplasia, tracheomalacia, tracheoesophageal fistula, gastroesophageal reflux, pertussis, congenital heart disease.
- •The patient has a history of some clinically significant adverse experience of a serious nature related to the administration of a marketed or investigational drug (eg, angioedema, anaphylaxis) or is otherwise sensitive to commercial or investigational drugs.
- •The patient has a history of a congenital illness or disease that could immediately threaten his life (for example: arrhythmias, congenital heart disease, labile diabetes, partially healed neoplasia or treated in the last 3 months), which represent a restriction for the participation or successful completion of the study or that would represent an additional risk for the administration of montelukast to the patient.
- •The patient has significant or unknown abnormalities in the physical examination and / or pre-study laboratory safety tests
- •Previous / Concurrent Medications
- •The patient has used drugs with known activities of inhibition or induction of metabolism of P-450 (such as phenobarbital, phenytoin, rifampin, erythromycin, trimethoprim / sulfaraetoxazole, ketoconazole [or other azoles]) within 2 weeks of the visit Pre-study
- •The patient has used astemizole within 3 months of the Pre-study visit, or terfenadine, ketotifen, anticholinergic and / or loratadine, within 2 weeks of the Pre-study visit.
- •The patient has used oral or parenteral corticosteroids within 2 weeks of the Pre-study visit.
- •The patient has used theophylline or anticholinergics within 2 weeks of the Pre-study visit.
- •The patient has used leukotriene agents within 2 weeks of the Pre-study visit.
- •The patient has had an increase in dose or a therapy with cromolin or nedocromil inhaled / nebulized that has recently been instituted within 2 weeks of the Pre-study visit.
- •The patient has had an increase in dose or a therapy with inhaled / nebulized corticosteroids that has recently been instituted within 2 weeks of the Pre-study visit.
- •The patient is in a situation or has a condition that, at the discretion of the investigator, may interfere with their optimal participation in the stu
研究者
相似试验
已完成
不适用
MULTICENTRIC DOUBLE-BLIND RANDOMIZED PARALLEL GROUPS CONTROLLED WITH PLACEBO STUDY WHOSE PURPOSE IS TO EVALUATE THE EFFECTIVENESS SAFETY AND TOLERABILITY OF F-1394 IN COMBINATION WITH THE REDUCTASE INHIBITOR HMG-COA SIMVASTATIN IN THE ALTERATION OF LIPIDSPER-058-00MERCK SHARP & DOHME PERU S.R.L.,
已完成
不适用
MULTICENTER, RANDOMIZED, DOUBLE-BLIND PARALLEL GROUPS STUDY TO EVALUATE THE EFFICACY, SAFETY AND TOLERABILITY OF A SINGLE ORAL DOSAGE OF 400 MG OF OXIBENDAZOL AGAINST A SINGLE ORAL DOSAGE OF 500 MG OF MEBENDAZAOL IN THE TREATMENT OF INTESTINAL HELMIANTIASIS IN ADULTS-B839 Helminthiasis, unspecifiedHelminthiasis, unspecifiedB839PER-010-01SMITHKLINE BEECHAM INTERAMERICAN,
进行中（未招募）
不适用
A RANDOMIZED, DOUBLE-BLIND, MULTICENTER PARALLEL GROUP STUDY ON EFFICACY AND SAFETY OF KETOTIFEN FUMARATE 0.05 OPHTHALMIC SOLUTION VERSUS KETOTIFEN FUMARATE 0.025 - KETOTIFENE 0.05Patients with seasonal allergic conjunctivitis and history of ocular allergies for at least 2 years.MedDRA version: 6.1Level: PTClassification code 10010744EUCTR2006-005681-39-ITFARMIGEA180
已完成
不适用
A MULTICENTER DOUBLE BLIND, RANDOMIZED, PARALLEL GROUP STUDY TO EVALUATE THE EFFECTS OF TWO DIFFERENT DOSIS OF LOSARTAN ON MORBIDITY AND MORTALITY IN PATIENTS WITH SYMPTOMATIC HEART FAILURE INTOLERANT TO ACE INHIBITOR TREATMENT-I50I50PER-060-01MERCK SHARP & DOHME PERU S.R.L.,
进行中（未招募）
不适用
MULTICENTRE, RANDOMISED, DOUBLE-BLIND, PARALLEL GROUP, PLACEBO-CONTROLLED STUDY ON THE THERAPEUTIC EFFICACY AND SAFETY OF BECLOMETHASONE DIPROPIONATE SUSPENSION FOR INHALATION 800 micrograms TWICE DAILY VS PLACEBO ADDED TO ANTIBIOTIC THERAPY IN PATIENTS WITH ACUTE RHINOSINUSITISAcute rhinosinusitisMedDRA version: 14.1Level: LLTClassification code 10052106Term: RhinosinusitisSystem Organ Class: 100000004862EUCTR2011-001459-35-ITCHIESI