NCT02183038已完成2 期
Double-blind Study to Compare Efficacy and Safety of Meloxicam 7.5 mg and 15 mg vs. Naproxen Sodium 1100 mg in the Symptomatic Treatment of Acute Non Bacterial Pharyngitis or Pharyngo-tonsillitis Over a Period of 5 Days
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 390
- 主要终点
- Change in intensity of spontaneous pharyngeal pain
研究概览
简要总结
Study to assess the efficacy and tolerability of Meloxicam once daily dose of 7.5 mg and 15 mg compared with 1100 mg of naproxen sodium in the symptomatic treatment of acute non bacterial pharyngitis or pharyngo-tonsillitis, over a period of 5 days.
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
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged 18 years or above
- •Ambulatory patients
- •Start of symptoms within the previous 24 hours
- •Patients suffering from acute non bacterial pharyngitis or pharyngo-tonsillitis diagnostic, under the following criteria:
- •spontaneous pharyngeal pain presence greater than 35 mm on a 100 mm visual analog scale (VAS)
- •Pharyngeal pain presence on swallowing greater than 35 mm on a 100 mm VAS
- •Pharyngeal and/or amygdaline hyperemia
- •Absence of purulent plaques
- •Negative test for β-haemolytic Streptococcus on pharyngeal exudate
- •Therapy with NSAID (Non-Steroid Anti-Inflammatory Drug) is required or recommended
- •Patient's informed consent in accordance with local law and ICH GCP (International Conference of Harmonization Good Clinical Practice) , before inclusion into the the trial
排除标准
- •Suspicion of acute pharyngitis or pharyngo-tonsillitis from bacterial origin by clinical criteria; Several impairment of patients condition, indicated by one or more or the following symptoms:
- •Extremely rapid onset of clinical picture
- •Very high fever (>38.5°C)
- •Severe pharyngeal pain
- •Cervical adenopathy
- •Intense headache
- •Purulent pharyngeal plaques, evidence of peritonsillar abscess or phlegmon
- •Known or suspected hypersensitivity to the trial drug or NSAIDs
- •Positive test for β-haemolytic Streptococcus on pharyngeal exudate
- •Therapy with antimicrobial agents prior to start of the trial
- •Chronic infections
- •Infectious mononucleosis
- •Active peptic ulcer within the past 6 months
- •Pregnancy or breast feeding precaution: attention should be drawn to reports that NSAIDs were reported to decrease the efficacy of intrauterine devices
- •Asthma, nasal polyps, angioneurotic edema or urticaria following the administration of aspirin or NSAIDs
- •Concomitant treatment with anti-coagulants (including heparin), lithium or methotrexate
- •Concomitant administration of other NSAIDs (including high-dose > 1500 mg at day aspirin) or analgesic agents
- •Administration of any NSAID during the last three days or analgesics 6 hours prior to the first administration of the trial drug
- •Present treatment or treatment within the last two months with corticosteroids
- •Historically know of impaired renal function (serum urea > 125 % of the upper limit of normal range; serum creatinine > 150 % of the upper limit of normal range)
- •Historically know of severe liver injury (alanine amino transferase ALAT > 2 x the upper normal range limit or aspartate amino transferase ASAT > 2 x the upper normal range limit)
- •Historically know of hematological disorder (platelet count < 100,000/mm3, leucocyte count < 3,000/mm3)
- •Participation in another clinical trial during this study or during the previous month
- •Previous participation in this trial
- •Patient unable to comply with the protocol
研究组 & 干预措施
Naproxen sodium & Placebo
Active Comparator
干预措施: Naproxen sodium (Drug)
Meloxicam low & Placebo
Experimental
干预措施: Meloxicam low (Drug)
Meloxicam low & Placebo
Experimental
干预措施: Meloxicam placebo high (Drug)
Meloxicam low & Placebo
Experimental
干预措施: Naproxen sodium placebo (Drug)
Meloxicam high & Placebo
Experimental
干预措施: Meloxicam high (Drug)
Meloxicam high & Placebo
Experimental
干预措施: Meloxicam placebo low (Drug)
Meloxicam high & Placebo
Experimental
干预措施: Naproxen sodium placebo (Drug)
Naproxen sodium & Placebo
Active Comparator
干预措施: Meloxicam placebo low (Drug)
Naproxen sodium & Placebo
Active Comparator
干预措施: Meloxicam placebo high (Drug)
结局指标
主要结局
Change in intensity of spontaneous pharyngeal pain
时间窗: Baseline, day 3 and 5
Change in intensity of pharyngeal pain on swallowing
时间窗: Baseline, day 3 and 5
次要结局
- Incidence of significant laboratory adverse events(up to 19 days)
- Occurrence of pharyngeal hyperemia(up to 5 days)
- Number of patients who withdraw due to adverse event(up to 19 days)
- Number of patients with adverse events(up to 19 days)
- Final global assessment of efficacy by patient(Day 5)
- Final global assessment of efficacy by investigator(Day 5)
- Occurrence of disease systemic manifestations (fever, and general malaise)(up to 5 days)
- Final global assessment of tolerability by patient(Day 5)
- Final global assessment of tolerability by investigator(Day 5)
- Assessment of patient status(Day 5)
- Occurrence of treatment withdrawal due to lack of efficacy(up to 5 days)
- Intensity of adverse events(up to 19 days)
- Occurrence and duration of hospital stay due to Gastro-Intestinal Serious Adverse Events (GI-SAE)(up to 19 days)
- Occurrence and duration of hospital stay due to adverse events related to trial drug administration(up to 19 days)
- Occurrence of an additional visit at physician due to gastro-intestinal adverse event (GI-AE)(up to 19 days)
- Occurrence of perforation, ulceration, bleeding (PUB) of the upper gastro-intestinal tract (stomach or duodenum)(up to day 5)
- Number of patients with adverse events related to trial drug(up to 19 days)
研究者
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