NCT02183025已完成2 期
Double Blind Study to Evaluate Efficacy and Safety of Meloxicam 7.5 mg and 15 mg Versus Mefenamic Acid 1500 mg in the Treatment of Dysmenorrhea
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
- 337
- 主要终点
- Evaluation of severity of lumbar and/or abdominal pain on a visual analogue scale (VAS)
研究概览
简要总结
To access the efficacy and safety of Meloxicam 7.5 mg and 15 mg once daily compared with Mefenamic acid 500 mg t.i.d. over a treatment period of 3-5 days, during an observation period of 3 menstrual cycles, for the symptomatic relief of primary dysmenorrhea
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 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients between 18 to 40 years
- •Patients experiencing primary (functional) dysmenorrhea during the last 3 consecutive menstrual periods. Diagnosis will be based on symptoms and clinical signs: abdominopelvic pain, may radiate to the back and along the thighs; systemic symptoms including nausea, vomit, diarrhoea, headache, fatigue, nervousness, dizziness; the symptomatology should be usually some hours to one day before commencement of visible vaginal bleeding
- •Evaluation of lumbar and/or abdominopelvic pain due to dysmenorrhea > 35 mm through a 100 mm visual analogue scale (VAS)
- •Outpatients
- •Patients granting their written informed consent
- •Therapy with a NSAID (nonsteroidal antiinflammatory drug) is required or recommended
排除标准
- •Known or suspected hypersensitivity to trial drugs or their excipients, analgesics, antipyretics or NASIDs
- •Analgesic concomitant treatment (between each cycle paracetamol administration will be allowed)
- •To initiate hormonal contraception or intrauterine devices after inclusion to this trial or during the last 3 months
- •Abdominal surgery or pelvic procedure scheduled during the study
- •Patients with organic dysmenorrhea (endometriosis, salpingitis, adnexitis, uterine retroversion, tubal cysts, ovarian cysts, pathological vaginal secretion, painful pelvic exploration, etc.)
- •Patients with neoplastic disorders
- •History of recent abdominal or pelvic trauma requiring surgery
- •Peptic ulcer within the past 6 months
- •Pregnancy or breast feeding
- •Asthma, nasal polyps, angioneurotic edema or rash following aspirin or NSAIDs administration
- •Concomitant treatment with anti-coagulants, including heparin and aspirin, lithium or methotrexate
- •Concomitant administration of other NSAIDs (including aspirin > 150 mg daily) or analgesics
- •Confinement to bed rest
- •Administration of any NSAID during two days (three for oxicams) before the first administration of the trial drug
- •Present treatment or treatment within the last two months with corticosteroids
- •Impaired renal function (serum urea > 125 % of the upper limit of normal range; serum creatinine > 150 % of the upper limit of normal range)
- •Sever 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)
- •Hematological disorder (platelet count < 100,000/mm**3, leucocyte count < 3,000/mm**3)
- •Participation in another clinical trial during this study or the previous month
- •Previous participation in this trial
- •Patient unable to comply with protocol
- •Bleeding disorders
研究组 & 干预措施
Meloxicam 7.5 mg
Experimental
干预措施: Meloxicam 7.5 mg (Drug)
Meloxicam 7.5 mg
Experimental
干预措施: Placebo matching 15 mg meloxicam (Drug)
Meloxicam 7.5 mg
Experimental
干预措施: Placebo matching 500 mg mefenamic acid (Drug)
Meloxicam 15 mg
Experimental
干预措施: Meloxicam 15 mg (Drug)
Meloxicam 15 mg
Experimental
干预措施: Placebo matching 7.5 mg meloxicam (Drug)
Meloxicam 15 mg
Experimental
干预措施: Placebo matching 500 mg mefenamic acid (Drug)
Mefenamic acid 1500 mg
Active Comparator
500 mg three times daily
干预措施: Mefenamic acid 500 mg (Drug)
Mefenamic acid 1500 mg
Active Comparator
500 mg three times daily
干预措施: Placebo matching 7.5 mg meloxicam (Drug)
Mefenamic acid 1500 mg
Active Comparator
500 mg three times daily
干预措施: Placebo matching 15 mg meloxicam (Drug)
结局指标
主要结局
Evaluation of severity of lumbar and/or abdominal pain on a visual analogue scale (VAS)
时间窗: Baseline and day 3-5 of each treatment cycle
次要结局
- Final global assessment of efficacy by patient on a 4-point scale(day 3-5 of the second treatment cycle)
- Final global assessment of efficacy by investigator on a 4-point scale(day 3-5 of the second treatment cycle)
- Final global assessment of tolerability by patient on a 4-point scale(day 3-5 of the second treatment cycle)
- Final global assessment of tolerability by investigator on a 4-point scale(day 3-5 of the second treatment cycle)
- Number of Participants with Adverse Events (AE)(Up to 4 weeks after last treatment cycle)
- Incidence of significant laboratory events(Up to 4 weeks after last treatment cycle)
- Number of perforations, ulcerations and/or bleedings (PUB) of the upper gastro-intestinal tract(Up to 4 weeks after last treatment cycle)
- Number of gastro-intestinal adverse events (GI-AEs)(Up to 4 weeks after last treatment cycle)
- Duration of hospitalization stay due to GI-AEs(Up to 4 weeks after last treatment cycle)
- Number of additional visits at physician due to GI-AEs(Up to 4 weeks after last treatment cycle)
- Duration of hospitalization due to drug related AEs(Up to 4 weeks after last treatment cycle)
- Number of withdrawals due to AEs(Up to 4 weeks after last treatment cycle)
- Change in severity of symptomatology associated with dysmenorrhea(Baseline and day 3-5 of each treatment cycle)
- Intensity of AEs on a 3-point scale(Up to 4 weeks after last treatment cycle)
- Evaluation of labor and/or daily life disability associated with dysmenorrhea on a VAS(Baseline and day 3-5 of each treatment cycle)
研究者
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