Treatment of cystitis in adult, non-pregnant wome

Phase 1

• Conditions: ncomplicated cystitis in adult, non pregnant women, age 18-60.; MedDRA version: 14.1 Level: LLT Classification code 10000699 Term: Acute cystitis (excl in pregnancy) System Organ Class: 100000004862; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2012-002776-14-NO
• Lead Sponsor: niversity of Oslo, Faculty of medicine, Institute of Health and Society

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-11-06
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 400

Inclusion Criteria

Woman between 18 and 60 years of age.
Dysuria and urinary frequency and/or urinary urgency.
Ability to speak, understand and write Norwegian/Swedish/Danish and ability to give consent.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 400
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Pregnancy/breastfeeding child under one month of age
Diabetes
Kidney disease or use of the drug probenecid
Clinical suspicion of pyelonefritis; 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
Previous allergic reaction to penicillin
Previous allergic reaction to ibuprofen, or worsening of asthma when taking NSAIDs
Narrow oesophagus
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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified