Clinical Trial: Efficacy Study of Methenamine + Methylthioninium Chloride vs Phenazopyridine for the Symptomatic Control of Dysuria

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Phase III, Prospective, Multicenter, Single-blind, Randomized, Superiority to Evaluate the Efficacy and Safety of Methenamine Association 250mg + Methylthioninium Chloride 20 mg Compared to Phenazopyr

Brief Summary: The purpose of this study is to evaluate the efficacy of the combination of Methenamine + Methylthioninium chloride compared to phenazopyridine (comparator product) in the symptomatic relief of dysuria.

Detailed Summary:

  • Single blind, randomized, prospective study.
  • Length of experience: 03 days to 07 days.
  • 03 visits (days 1, 4 and 7).
  • Evaluation of the efficacy and safety of the medication.
  • Shall be assessed for adverse events.

Sponsor: EMS

Current Primary Outcome: Efficacy of treatment in the symptomatic relief of dysuria [ Time Frame: 3 days ]

Original Primary Outcome: Efficacy of treatment in the rapid relief of symptoms in uncomplicated lower urinary tract infection [ Time Frame: 3 days ]

Symptoms will be assessed during the first 24 hours as pollakiuria, cystalgia, dysuria, urinary urgency and odor through the report of the patient (subjective parameter) and objective evaluation through laboratory tests and urine culture Urine I, comparing, after 3 days treatment, the results between groups.


Current Secondary Outcome: Safety of the study medication [ Time Frame: 7 days ]

To assess the safety of the study medication on the occurrence, type, intensity and frequency of adverse reactions during the treatment period.


Original Secondary Outcome: Safety of the study medication [ Time Frame: 5 days ]

To assess the safety of the study medication on the occurrence, type, intensity and frequency of adverse reactions during the treatment period.


Information By: EMS

Dates:
Date Received: August 2, 2012
Date Started: January 2016
Date Completion: October 2016
Last Updated: August 24, 2015
Last Verified: August 2015