NCT01849926

Ibuprofen Versus Mecillinam for Uncomplicated Cystitis

Ibuprofen Versus Mecillinam for Uncomplicated Cystitis in Adult, Non-pregnant Women

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 383 (actual)
• Sponsor: University of Oslo · Academic / Other
• Sex: Female
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Acute Cystitis (Excl in Pregnancy)

Interventions

Type	Name	Description
DRUG	Ibuprofen
DRUG	Mecillinam

Timeline

• Start date: 2013-04-01
• Primary completion: 2016-07-01
• Completion: 2016-07-01
• First posted: 2013-05-09
• Last updated: 2017-11-06

Locations

1 site across 1 country: Norway