Ibuprofen Versus Mecillinam for Uncomplicated Cystitis (IMUTI)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by University of Oslo
Sponsor:
Collaborators:
University of Bergen
Lund University
University of Copenhagen
Information provided by (Responsible Party):
Morten Lindbaek, University of Oslo
ClinicalTrials.gov Identifier:
NCT01849926
First received: April 4, 2013
Last updated: May 8, 2013
Last verified: May 2013
  Purpose

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 Intervention Phase
Acute Cystitis (Excl in Pregnancy)
Drug: Ibuprofen
Drug: Mecillinam
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Ibuprofen Versus Mecillinam for Uncomplicated Cystitis in Adult, Non-pregnant Women

Resource links provided by NLM:


Further study details as provided by University of Oslo:

Primary Outcome Measures:
  • Number of patients who are symptom free by day four [ Time Frame: Four days ] [ Designated as safety issue: No ]
    Both symptom load with regard to specific symptoms and when feeling completely symptom free will be registered in the patient diary.


Secondary Outcome Measures:
  • The patients' symptom load with regard to specific symptoms. [ Time Frame: Seven days ] [ Designated as safety issue: No ]
    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:
  • Proportion of patients who were in need of a secondary medical consult within the study period. [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Proportion of patients who developed an upper urinary tract infection (pyelonephritis). [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • Proportion of patients who experienced severe adverse effects. [ Time Frame: Seven days ] [ Designated as safety issue: No ]
  • Proportion of patients who had a relapse of symptoms within four weeks after being included in the study. [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Proportion of patients with a positive urine culture after four weeks. [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 440
Study Start Date: May 2013
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ibuprofen
Tablet, over capsulated, 600mg three times a day for three days.
Drug: Ibuprofen
Other Names:
  • Ibux
  • Ibuprofen
Active Comparator: Mecillinam
Tablet, over capsulated, 200mg three times a day for three days.
Drug: Mecillinam
Other Names:
  • Selexid
  • Penomax

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  • heart insufficiency
  • severe psychiatric illness or dementia
  • severe drug addiction
  • unable to communicate in Norwegian, Swedish or Danish language
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01849926

Contacts
Contact: Ingvild Vik, Cand. med. +47 40164248 ingvild.vik@medisin.uio.no

Locations
Norway
University of Oslo Recruiting
Oslo, Norway
Sponsors and Collaborators
University of Oslo
University of Bergen
Lund University
University of Copenhagen
Investigators
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
  More Information

No publications provided

Responsible Party: Morten Lindbaek, Professor dr. med, University of Oslo
ClinicalTrials.gov Identifier: NCT01849926     History of Changes
Other Study ID Numbers: UiO_IMUTI
Study First Received: April 4, 2013
Last Updated: May 8, 2013
Health Authority: Norway: Regional Ethics Commitee
Norway: Norwegian Medicines Agency

Additional relevant MeSH terms:
Cystitis
Urinary Bladder Diseases
Urologic Diseases
Amdinocillin
Ibuprofen
Anti-Infective Agents, Urinary
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Renal Agents
Anti-Bacterial Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
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
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 21, 2014