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

• Status: Completed
• Trial end date: 2017-12-22
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: EMS
• Treatments: Methenamine; Methenamine hippurate; Methenamine mandelate; Methylene Blue

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.