A Phase 4 interventional study of Ibuprofen and Mecillinam in Acute Cystitis (Excl in Pregnancy), sponsored by University of Oslo. Completed at 1 site in Norway. Open to female participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-11-06.
Sponsored by University of Oslo · Phase 4, Interventional, and Treatment
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.
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.
235 studies on the registry are indexed under Cystitis; 22 are open to participants now.
This study's enrollment of 383 is above the median of 60 across 170 interventional studies indexed under Cystitis.
Browse Cystitis studies →University of Oslo is the lead sponsor of 176 studies on the registry; 23 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Tablet, over capsulated, 600mg three times a day for three days.
Drug: Ibuprofen
Tablet, over capsulated, 200mg three times a day for three days.
Drug: Mecillinam
Also known as: Ibux
Also known as: Selexid, Penomax
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.
Time frame: Four days
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.
Time frame: Seven days
Proportion of patients who were in need of a secondary medical consult within the study period.
Time frame: 28 days
Proportion of patients who developed an upper urinary tract infection (pyelonephritis).
Time frame: 14 days
Proportion of patients who experienced severe adverse effects.
Time frame: Seven days
Proportion of patients who had a relapse of symptoms within four weeks after being included in the study.
Time frame: 28 days
Proportion of patients with a positive urine culture after four weeks.
Time frame: 28 days
This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
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University of Oslo