Status:
COMPLETED
Ibuprofen Versus Mecillinam for Uncomplicated Cystitis
Lead Sponsor:
University of Oslo
Collaborating Sponsors:
University of Bergen
Lund University
Conditions:
Acute Cystitis (Excl in Pregnancy)
Eligibility:
FEMALE
18-60 years
Phase:
PHASE4
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 re...
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...
Eligibility Criteria
Inclusion
- woman between 18 and 60 years of age
- dysuria and pollakiuria and/or urinary urgency
- ability to give written consent
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2016
Estimated Enrollment :
383 Patients enrolled
Trial Details
Trial ID
NCT01849926
Start Date
April 1 2013
End Date
July 1 2016
Last Update
November 6 2017
Active Locations (1)
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1
University of Oslo
Oslo, Norway