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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01657448
Recruitment Status : Unknown
Verified August 2015 by EMS.
Recruitment status was:  Not yet recruiting
First Posted : August 6, 2012
Last Update Posted : August 25, 2015
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Dysuria Drug: Methenamine and Methylthioninium chloride Drug: Phenazopyridine Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 316 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : January 2016
Estimated Primary Completion Date : July 2016
Estimated Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

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

Secondary Outcome Measures :
  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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01657448

Contact: Joyce Macedo Silva, MD + 55 19 9212 9851

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

Responsible Party: EMS Identifier: NCT01657448     History of Changes
Other Study ID Numbers: CYSEMS0112
First Posted: August 6, 2012    Key Record Dates
Last Update Posted: August 25, 2015
Last Verified: August 2015

Keywords provided by EMS:
Symptom of Dysuria

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