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Clinical Trials/ISRCTN43397016
ISRCTN43397016
Completed
Phase 3

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

niversity of Southampton0 sites376 target enrollmentFebruary 11, 2015
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ConditionsTopic: Primary CareSubtopic: Infectious diseases and microbiology, Primary careDisease: All DiseasesInfections and Infestations

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Topic: Primary Care
Sponsor
niversity of Southampton
Enrollment
376
Status
Completed
Last Updated
7 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

2017 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/28886751 2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/30685500

Registry
who.int
Start Date
February 11, 2015
End Date
May 31, 2017
Last Updated
7 years ago
Study Type
Interventional
Sex
Female

Investigators

Sponsor
niversity of Southampton

Eligibility Criteria

Inclusion Criteria

  • •1\. 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
  • •2\. Patient able to provide informed written consent
  • •3\. Women willing to accept a delayed prescription for antibiotics

Exclusion Criteria

  • •Current exclusion criteria as of 13/09/2016:
  • •1\. 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)
  • •2\. Known immunodeficiency state, long term corticosteroids therapy or chemotherapy
  • •3\. Diabetes
  • •4\. Has any of the following known contraindications or cautions to Ibuprofen and any as listed in the current SmPC:
  • •4\.1\. Asthmatics sensitive to NSAIDS/Ibuprofen or Aspirin
  • •4\.2\. Severe heart failure and uncontrolled hypertension
  • •4\.3\. Active gastrointestinal ulceration or bleeding
  • •4\.4\. Crohn’s disease or ulcerative colitis
  • •4\.5\. Documented poor renal function

Outcomes

Primary Outcomes

Not specified

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