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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2015 by EMS
Information provided by (Responsible Party):
ClinicalTrials.gov Identifier:
First received: August 2, 2012
Last updated: August 24, 2015
Last verified: August 2015

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.

Condition Intervention Phase
Drug: Methenamine and Methylthioninium chloride
Drug: Phenazopyridine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
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 Phenazopyridine 100 mg in Symptomatic Control of Dysuria

Resource links provided by NLM:

Further study details as provided by EMS:

Primary Outcome Measures:
  • Efficacy of treatment in the symptomatic relief of dysuria [ Time Frame: 3 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety of the study medication [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
    To assess the safety of the study medication on the occurrence, type, intensity and frequency of adverse reactions during the treatment period.

Estimated Enrollment: 316
Study Start Date: January 2016
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Methenamine, Methylthioninium Drug: Methenamine and Methylthioninium chloride
• Ingesting two (02) tablets of the drug with a glass of water, every 8 hours for 3 days
Active Comparator: Phenazopyridine Drug: Phenazopyridine
• Ingesting two (02) tablets of the drug with a glass of water, every 8 hours for 3 days
Other Name: Pyridium

Detailed Description:
  • 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.

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01657448

Contact: Joyce Macedo Silva, MD + 55 19 9212 9851 pesquisa.clinica@ems.com.br

Centro de Medicina Reprodutiva Carlos Isaia Filho Ltda Not yet recruiting
Porto Alegre, Rio Grande do Sul, Brazil
Contact: Carlos Isaia Filho, MD         
UNISA Not yet recruiting
Santo Amaro, São Paulo, Brazil
Contact: Lucia Hime, MD         
Marcio Antonio Pereira Clinica de Endocrinologia Not yet recruiting
São José dos Campos, São Paulo, Brazil
Contact: Marcio A. Pereira, MD         
AFIP Not yet recruiting
São Paulo, Brazil
Contact: Helena H. Campos, MD         
Savmed Clinica Médica S/C Ltda. Not yet recruiting
São Paulo, Brazil
Contact: Felício Savióli, MD         
Sociedade de atendimento Cardiológico LTDA Not yet recruiting
São Paulo, Brazil
Contact: Nabil Ghorayeb, MD         
Principal Investigator: Patrícia Smith, MD         
USP Not yet recruiting
São Paulo, Brazil
Contact: Ceci M Carvalho Lopes, MD         
Sponsors and Collaborators
  More Information

No publications provided

Responsible Party: EMS
ClinicalTrials.gov Identifier: NCT01657448     History of Changes
Other Study ID Numbers: CYSEMS0112
Study First Received: August 2, 2012
Last Updated: August 24, 2015
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by EMS:
Symptom of Dysuria

Additional relevant MeSH terms:
Lower Urinary Tract Symptoms
Signs and Symptoms
Urological Manifestations
Methenamine hippurate
Methylene Blue
Anti-Infective Agents
Anti-Infective Agents, Urinary
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Renal Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 09, 2015