Ibuprofen Versus Mecillinam for Uncomplicated Cystitis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Ibuprofen Versus Mecillinam for Uncomplicated Cystitis in Adult, Non-pregnant Women

Conditions
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Acute Cystitis (Excl in Pregnancy)

Intervention / Treatment
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* Drug: Ibuprofen
* Drug: Mecillinam


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: woman between 18 and 60 years of age dysuria and pollakiuria and/or urinary urgency ability to give written consent Exclusion Criteria: pregnancy/breastfeeding child under one month of age diabetes 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ibuprofen<br>Tablet, over capsulated, 600mg three times a day for three days. | Drug: Ibuprofen<br> <br> * Other names: Ibux;|
| Active Comparator: Mecillinam<br>Tablet, over capsulated, 200mg three times a day for three days. | Drug: Mecillinam<br> <br> * Other names: Penomax;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients who are symptom free by day four | Both symptom load with regard to specific symptoms and when feeling completely symptom free will be registered in the patient diary. | Four days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The patients' symptom load with regard to specific symptoms. | Specific symptoms, such as dysuria, urgency and pollakiuria, will be given a number from 0-6 in the patient diary, 0 = no problem and 6= as bad as it can get. | Seven days |