EUCTR2013-003327-11-GB
Active, not recruiting
Phase 1
Alternative Treatments of Adult female Urinary Tract Infection: a double blind, placebo controlled,factorial randomised trial of Uva ursi and open pragmatic trial of ibuprofen. - ATAFUTI
niversity of Southampton0 sites382 target enrollmentDecember 17, 2014
ConditionsAcute urinary tract infections.MedDRA version: 19.0 Level: LLT Classification code 10000698 Term: Acute cystitis System Organ Class: 100000004862Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
DrugsARCTUVAN
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Acute urinary tract infections.
- Sponsor
- niversity of Southampton
- Enrollment
- 382
- Status
- Active, not recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Adult women (18\-70\) presenting to primary care with suspected lower urinary tract infection i.e. with at least one of dysuria, urgency or frequency.
- •Patient able to provide informed written consent.
- •Women willing to accept a delayed prescription for antibiotics.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 376
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 1
Exclusion Criteria
- •Known or suspected pregnancy or breast feeding
- •In women of child bearing age a urine pregnancy test will usually be performed unless not indicated (for instance prior hysterectomy)
- •Known immunodeficiency state, long term corticosteroids therapy or chemotherapy
- •Has any of the following (A – F) known contra\-indications or cautions to Ibuprofen and any as listed in the current SmPC:
- •A. Asthmatics sensitive to NSAIDS/ Ibuprofen or Aspirin
- •B. Severe heart failure and uncontrolled hypertension
- •C. Active gastro\-intestinal ulceration or bleeding
- •D. Crohn’s disease or ulcerative colitis
- •E. Documented poor renal function
- •F. Chronic Kidney disease (Grade 3 \- 5\)
Outcomes
Primary Outcomes
Not specified
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