Ibuprofen Versus Mecillinam for Uncomplicated Cystitis

Overview

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.

Full Title of Study: “Ibuprofen Versus Mecillinam for Uncomplicated Cystitis in Adult, Non-pregnant Women”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: July 2016

Detailed Description

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.

Interventions

  • Drug: Ibuprofen
  • Drug: Mecillinam

Arms, Groups and Cohorts

  • Active Comparator: Ibuprofen
    • Tablet, over capsulated, 600mg three times a day for three days.
  • Active Comparator: Mecillinam
    • Tablet, over capsulated, 200mg three times a day for three days.

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • The patients’ symptom load with regard to specific symptoms.
    • Time Frame: Seven days
    • 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.

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Oslo
  • Collaborator
    • University of Bergen
  • Provider of Information About this Clinical Study
    • Principal Investigator: Morten Lindbaek, Professor dr. med – University of Oslo
  • Overall Official(s)
    • Morten Lindbæk, Professor, Principal Investigator, University of Oslo, faculty of medicine, institute for health and society, department of general medicine, antibiotic centre of primary care

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