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Trial · Interventional

CompletedPhase 3Registry data

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

NCTNCT01657448 (opens ClinicalTrials.gov in a new tab)Other idCYSEMS0112
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
316 participants (actual)
Sponsor
EMS · Industry
Design
Randomized · Single masking
Countries
1 country

Brazil

Start
27 Jun 2016
Primary completion
21 Nov 2016
Completion
22 Dec 2017
First posted
6 Aug 2012 (estimated)
Last update posted
7 Jul 2020
Conditions
Dysuria

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201620172018
  1. Ph 3

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

    NCT01657448

    27 Jun 2016 to 22 Dec 2017

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Methenamine and Methylthioninium chlorideDrug
  • PhenazopyridineDrug

Arms2

  • Experimental

    Methenamine, Methylthioninium

  • Active comparator

    Phenazopyridine

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Efficacy of treatment in the symptomatic relief of dysuria

    Time frame · 3 days

Secondary outcomes(1)

  1. Safety of the study medication

    Time frame · 7 days

    Registry description

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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Patients who agree to participate by agreeing to the terms proposed in the Clinical trial; * Patients aged over 18 years of any ethnicity; * Presence of dysuria with marking greater than or equal to 5 measured points on the categorical scale pre-treatment for pain symptom; Exclusion Criteria: * Patients who are febrile (axillary T º: ≥ 38 ° C), with back pain or lumbar; * Patients with complicated clinical presentation of urinary tract infection; * Patients with a history of allergy or intolerance to any known or suspected one of the ingredients of the product under investigation; * Patients who are pregnant or during lactation, or childbearing potential and are not making use of effective contraception; * Patients presenting with renal disease or severe liver disease, according to medical history and / or laboratory; * Patients presenting with severe systemic disease according to the known medical history; * Patients who received antibiotic treatment, anthelmintic within 7 days prior to study entry; * Patients unable to understand the guidelines specified in this protocol or can not attend all study visits or unable to complete the log; * Pregnancy or risk of pregnancy and lactating patients; * Any finding of clinical observation (history and physical examination) that is interpreted by the physician investigator as a risk to the patient's participation in the study.

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