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

Primary Purpose

Dysuria

Status
Completed
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Methenamine and Methylthioninium chloride
Phenazopyridine
Sponsored by
EMS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dysuria focused on measuring Symptom of Dysuria

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Centro de Medicina Reprodutiva Carlos Isaia Filho Ltda
  • Marcio Antonio Pereira Clinica de Endocrinologia
  • AFIP
  • Savmed Clinica Médica S/C Ltda.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Methenamine, Methylthioninium

Phenazopyridine

Arm Description

Outcomes

Primary Outcome Measures

Efficacy of treatment in the symptomatic relief of dysuria

Secondary Outcome Measures

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

Full Information

First Posted
August 2, 2012
Last Updated
July 1, 2020
Sponsor
EMS
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1. Study Identification

Unique Protocol Identification Number
NCT01657448
Brief Title
Efficacy Study of Methenamine + Methylthioninium Chloride vs Phenazopyridine for the Symptomatic Control of Dysuria
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 Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
June 27, 2016 (Actual)
Primary Completion Date
November 21, 2016 (Actual)
Study Completion Date
December 22, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EMS

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysuria
Keywords
Symptom of Dysuria

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
316 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Methenamine, Methylthioninium
Arm Type
Experimental
Arm Title
Phenazopyridine
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Methenamine and Methylthioninium chloride
Intervention Description
• Ingesting two (02) tablets of the drug with a glass of water, every 8 hours for 3 days
Intervention Type
Drug
Intervention Name(s)
Phenazopyridine
Other Intervention Name(s)
Pyridium
Intervention Description
• Ingesting two (02) tablets of the drug with a glass of water, every 8 hours for 3 days
Primary Outcome Measure Information:
Title
Efficacy of treatment in the symptomatic relief of dysuria
Time Frame
3 days
Secondary Outcome Measure Information:
Title
Safety of the study medication
Description
To assess the safety of the study medication on the occurrence, type, intensity and frequency of adverse reactions during the treatment period.
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Centro de Medicina Reprodutiva Carlos Isaia Filho Ltda
City
Porto Alegre
State/Province
Rio Grande Do Sul
Country
Brazil
Facility Name
Marcio Antonio Pereira Clinica de Endocrinologia
City
São José dos Campos
State/Province
São Paulo
Country
Brazil
Facility Name
AFIP
City
São Paulo
Country
Brazil
Facility Name
Savmed Clinica Médica S/C Ltda.
City
São Paulo
Country
Brazil

12. IPD Sharing Statement

Learn more about this trial

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

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