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Completed

NCT Number: NCT01657448

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Centro de Medicina Reprodutiva Carlos Isaia Filho Ltda, Porto Alegre, Rio Grande do Sul, Brazil

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About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Methenamine and Methylthioninium chloride

Drug
  • Ingesting two (02) tablets of the drug with a glass of water, every 8 hours for 3 days

Phenazopyridine

Drug
  • Ingesting two (02) tablets of the drug with a glass of water, every 8 hours for 3 days

Other names: Pyridium

Primary outcomes

  1. Efficacy of treatment in the symptomatic relief of dysuria

    Time frame: 3 days

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

EMS

Industry

Registry information

Official study 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 Phenazopyridine 100 mg in Symptomatic Control of Dysuria

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Aug 6, 2012
Registry last updated
Jul 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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