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

EMS

Status and phase

Completed

Phase 3

Conditions

Dysuria

Treatments

Drug: Methenamine and Methylthioninium chloride

Drug: Phenazopyridine

Study type

Interventional

Funder types

Industry

Identifiers

NCT01657448

CYSEMS0112

Details and patient eligibility

About

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.

Full 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.

Enrollment

316 patients

Sex

All

Ages

18+ years old

Volunteers

No 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.