Ibuprofen Versus Mecillinam for Uncomplicated Cystitis in Adult, Non-pregnant Women
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 383
- 试验地点
- 1
- 主要终点
- Number of patients who are symptom free by day four
研究概览
简要总结
Although uncomplicated cystitis is considered to be a mild condition and mostly self limiting, most patients who see a doctor will be treated with antibiotics. Antibiotics are known to give a quick relief of symptoms and shorten the course of the condition by a few days. The aim of this study is to evaluate ibuprofen versus mecillinam in the treatment of uncomplicated cystitis in otherwise healthy, non-pregnant women. Our main objective is to see whether symptomatic treatment with ibuprofen is equally efficient as treatment with mecillinam in this group.
详细描述
The design of the study will be a double blinded randomized controlled trial (RCT). Half of the patients will receive treatment with mecillinam and the other half will receive treatment with ibuprofen. The study will follow the principles of Good Clinical Practice (GCP).
Urine cultures will be obtained on day one and after two weeks. The patients will be given a diary where they daily will register symptom load, possible complications or adverse effects and on which day they feel completely cured. We will contact the patients after two weeks to make sure they have followed the study procedures. After four weeks we will perform a final interview with the patient.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •woman between 18 and 60 years of age
- •dysuria and pollakiuria and/or urinary urgency
- •ability to give written consent
排除标准
- •pregnancy/breastfeeding child under one month of age
- •kidney disease
- •organic aciduria
- •clinical suspicion of pyelonephritis; fever, reduced general condition, upper back pain
- •vaginal symptoms such as discharge or irritation
- •severe abdominal pain
- •symptoms that have lasted for more than seven days
- •one or more urinary tract infections within the lasts four weeks
- •permanent bladder catheter or use of bladder catheter within the last four weeks
- •use of antibiotics within the last two weeks
- •participated in a clinical trial within the last four weeks
- •previously undergone a pyelonephritis
- •previous allergic reaction to penicillin
- •previous allergic reaction to ibuprofen, or worsening of asthma when using nonsteroidal antiinflammatory drugs(NSAIDs)
- •narrow oesophagus
- •use of the drug probenecid
- •severe gastritis or previous ulcer
- •anticoagulative treatment
- •ongoing use of steroids
- •use of immunosuppressant drugs
- •thrombocytopenia,
- •Chrohn's disease or Ulcerative colitis
- •heart insufficiency
- •severe psychiatric illness or dementia
- •severe drug addiction
- •unable to communicate in Norwegian, Swedish or Danish language
研究组 & 干预措施
Ibuprofen
Tablet, over capsulated, 600mg three times a day for three days.
干预措施: Ibuprofen (Drug)
Mecillinam
Tablet, over capsulated, 200mg three times a day for three days.
干预措施: Mecillinam (Drug)
结局指标
主要结局
Number of patients who are symptom free by day four
时间窗: Four days
Both symptom load with regard to specific symptoms and when feeling completely symptom free will be registered in the patient diary.
次要结局
- The patients' symptom load with regard to specific symptoms.(Seven days)
研究者
Morten Lindbaek
Professor dr. med
University of Oslo