NCT02229747已完成4 期
Randomized, Open-label, Controlled Trial to Assess the Clinical Efficacy and Safety of Meloxicam Suspension 0.25 mg/kg/Day Once a Day, Versus Diclofenac 1 mg/kg/Day Twice a Day or Nimesulide 4 mg/kg/Day Twice a Day, for Five Days in the Treatment of Patients With Acute, Non-bacterial Pharyngitis, Pharyngotonsillitis or Laryngitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 128
- 主要终点
- Change in pharyngeal pain on deglutition (dysphagia)
研究概览
简要总结
The objective of this study was to assess the clinical efficacy and safety of meloxicam suspension 0.25 mg/kg/day once a day, versus diclofenac suspension 1 mg/kg/day twice a day or nimesulide suspension 4 mg/kg/day twice a day, after five days of treatment in patients with a diagnosis of acute, non-bacterial pharyngitis, pharyngotonsillitis or laryngitis
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of both genders between 2 and 8 years old
- •Outpatients, with onset of symptoms not more than 72 hours prior to presentation, patients with acute non-bacterial pharyngitis or pharyngotonsillitis diagnosed according to the following criteria:
- •Spontaneous pharyngeal pain, pharyngeal pain upon swallowing, pharyngeal and/or tonsillar hyperemia, absence of purulent plaques, pharyngeal smear negative for ß-hemolytic Streptococcus or Strepto Test® and Treatment with an Non-steroidal anti-inflammatory drugs (NSAID) required or recommended
排除标准
- •Known or suspected hypersensitivity to study medications or NSAID's
- •Pharyngeal smear positive for ß-hemolytic Streptococcus
- •treatment with antimicrobials prior to enrolment in the study
- •Chronic infection, infectious mononucleosis, peptic ulcer disease that has been active in the previous 6 months
- •nasal polyps
- •angioneurotic edema or urticaria after the administration of aspirin or NSAID's
- •Concomitant treatment with anticoagulants (including heparin), lithium or methotrexate
- •Concomitant administration of other NSAID's (including high dose aspirin) or analgesics, except authorized rescue drugs
- •Administration of any NSAID during the three previous days or of analgesics within six hours prior to the administration of the first study drug dose
- •Treatment with corticosteroids at the time of enrollment or within the two previous months
- •Known liver, renal or hematological disease
- •Participation in another clinical trial during the study period or during the previous month
- •Previous enrollment in this study
- •Inability to comply with the protocol
- •Suspected acute bacterial pharyngitis or pharyngotonsillitis (under the following clinical criteria):
- •Clinical presentation characterized by a rapid onset, very high fever (>38.5°C), severe pharyngeal pain, cervical adenopathy, intense headache, purulent pharyngeal plaques, evidence of peritonsillar abscess or phlegmon
研究组 & 干预措施
Meloxicam suspension
Experimental
干预措施: Meloxicam (Drug)
Diclofenac suspension
Active Comparator
干预措施: Diclofenac (Drug)
Nimesulide suspension
Active Comparator
干预措施: Nimesulide (Drug)
结局指标
主要结局
Change in pharyngeal pain on deglutition (dysphagia)
时间窗: baseline, 5 days
Change in spontaneous pharyngeal pain
时间窗: baseline, 5 days
Incidence of adverse events
时间窗: baseline, 5 days
Change in pharyngeal hyperemia
时间窗: baseline, 5 days
Change in systemic manifestations (fever, adenomegaly and general malaise)
时间窗: baseline, 5 days
次要结局
未报告次要终点
研究者
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