Treatment of cystitis in adult, non-pregnant wome
- Conditions
- ncomplicated cystitis in adult, non pregnant women, age 18-60.MedDRA version: 17.1Level: LLTClassification code 10000699Term: Acute cystitis (excl in pregnancy)System Organ Class: 100000004862Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
- Registration Number
- EUCTR2012-002776-14-DK
- Lead Sponsor
- niversity of Oslo
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 400
Women between 18 and 60 years of age. Dysuria and urinary frequency and/or urinary urgency. Ability to speak, understand and write Danish and ability to understand and sign the inform consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 400
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Pregnancy. Breastfeeding. Diabetes. kidney disease or use of the drug probenecid. Clinical suspicion of pyelonefritis: fever, reduced general condition, upper back pain. Vaginal symptoms such as discharge or irritation. Severe abdominal pain More than seven days with symptoms. 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. Previous allergic reaction to penicillin. Previous allergic reaction to ibuprofen, or worsening of asthma when taking NSAIDs. Narrow oesophagus. Severe gastritis or previous ulcer. Anticoagulative treatment. Ongoing use of steroids Use of immunosuppressant drugs. Thrombocytopenia Heart insufficiency. Severe psychiatric illness or dementia. Severe drug addiction. Unable to communicate in Norwegian, Swedish or Danish language.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Uncomplicated cystitis is considered to be a mild condition and mostly self-limiting. Currently, the majority of patients are treated with antibiotics, which 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 assess whether symptomatic treatment with ibuprofen is equally effective as the treatment with mecillinam.;Secondary Objective: Are there more complications in the ibuprofen group compared to the mecillinam group? Are there more positive urine cultures in the ibuprofen group after two weeks?;Primary end point(s): Proportion of patients who feel cured by day four as registered in the patient diary.;Timepoint(s) of evaluation of this end point: Four days
- Secondary Outcome Measures
Name Time Method Secondary end point(s): The patients’ symptom load with regard to dysuria, urinary frequency and/or urinary urgency. Proportion of patients who had a relapse of symptoms of uncomplicated cystitis within the study period. Proportion of patients who were in need of a secondary medical consultation within the study period. Proportion of patients who developed an upper urinary tract infection (pyelonefritis). Proportion of patients who experienced severe adverse effects. Proportion of patients with a positive urine culture after two weeks.;Timepoint(s) of evaluation of this end point: Two weeks