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 ]
Current Secondary Outcome: Safety of the study medication [ Time Frame: 7 days ]
Original Secondary Outcome: Safety of the study medication [ Time Frame: 5 days ]
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