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

Sponsor

EMS (Industry)

Overall Status

Completed

CT.gov ID

NCT01657448

Collaborator

(none)

316

Enrollment

Locations

Arms

17.8

Actual Duration (Months)

Patients Per Site

4.4

Patients Per Site Per Month

Study Details

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.

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 Design

Study Type:

Interventional

Actual 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

Actual Study Start Date :

Jun 27, 2016

Actual Primary Completion Date :

Nov 21, 2016

Actual Study Completion Date :

Dec 22, 2017

Arms and Interventions

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 Names: Pyridium

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 Names:

Pyridium

Outcome Measures

Primary Outcome Measures

Efficacy of treatment in the symptomatic relief of dysuria [3 days]

Secondary Outcome Measures

Safety of the study medication [7 days]
To assess the safety of the study medication on the occurrence, type, intensity and frequency of adverse reactions during the treatment period.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country
1	Centro de Medicina Reprodutiva Carlos Isaia Filho Ltda	Porto Alegre	Rio Grande Do Sul	Brazil
2	Marcio Antonio Pereira Clinica de Endocrinologia	São José dos Campos	São Paulo	Brazil
3	AFIP	São Paulo		Brazil
4	Savmed Clinica Médica S/C Ltda.	São Paulo		Brazil