Acute Cystitis (Excl in Pregnancy) Clinical Trial
— IMUTIOfficial title:
Ibuprofen Versus Mecillinam for Uncomplicated Cystitis in Adult, Non-pregnant Women
| Verified date | November 2017 |
| Source | University of Oslo |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 383 |
| Est. completion date | July 2016 |
| Est. primary completion date | July 2016 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 18 Years to 60 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Norway | University of Oslo | Oslo |
| Lead Sponsor | Collaborator |
|---|---|
| University of Oslo | Lund University, University of Bergen, University of Copenhagen |
Norway,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Proportion of patients who were in need of a secondary medical consult within the study period. | 28 days | ||
| Other | Proportion of patients who developed an upper urinary tract infection (pyelonephritis). | 14 days | ||
| Other | Proportion of patients who experienced severe adverse effects. | Seven days | ||
| Other | Proportion of patients who had a relapse of symptoms within four weeks after being included in the study. | 28 days | ||
| Other | Proportion of patients with a positive urine culture after four weeks. | 28 days | ||
| Primary | 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 | 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 |