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Ibuprofen Versus Mecillinam for Uncomplicated Cystitis (IMUTI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01849926
Recruitment Status : Completed
First Posted : May 9, 2013
Last Update Posted : November 6, 2017
University of Bergen
Lund University
University of Copenhagen
Information provided by (Responsible Party):
Morten Lindbaek, University of Oslo

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Acute Cystitis (Excl in Pregnancy) Drug: Ibuprofen Drug: Mecillinam Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 383 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Ibuprofen Versus Mecillinam for Uncomplicated Cystitis in Adult, Non-pregnant Women
Study Start Date : April 2013
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Arm Intervention/treatment
Active Comparator: Ibuprofen
Tablet, over capsulated, 600mg three times a day for three days.
Drug: Ibuprofen
Other Name: Ibux

Active Comparator: Mecillinam
Tablet, over capsulated, 200mg three times a day for three days.
Drug: Mecillinam
Other Names:
  • Selexid
  • Penomax

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

Other Outcome Measures:
  1. Proportion of patients who were in need of a secondary medical consult within the study period. [ Time Frame: 28 days ]
  2. Proportion of patients who developed an upper urinary tract infection (pyelonephritis). [ Time Frame: 14 days ]
  3. Proportion of patients who experienced severe adverse effects. [ Time Frame: Seven days ]
  4. Proportion of patients who had a relapse of symptoms within four weeks after being included in the study. [ Time Frame: 28 days ]
  5. Proportion of patients with a positive urine culture after four weeks. [ Time Frame: 28 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01849926

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University of Oslo
Oslo, Norway
Sponsors and Collaborators
University of Oslo
University of Bergen
Lund University
University of Copenhagen
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Principal Investigator: Morten Lindbæk, Professor University of Oslo, faculty of medicine, institute for health and society, department of general medicine, antibiotic centre of primary care
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Morten Lindbaek, Professor dr. med, University of Oslo
ClinicalTrials.gov Identifier: NCT01849926    
Other Study ID Numbers: UiO_IMUTI
First Posted: May 9, 2013    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: November 2017
Additional relevant MeSH terms:
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Urinary Bladder Diseases
Urologic Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Male Urogenital Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Anti-Infective Agents
Anti-Bacterial Agents