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

Sponsored by EMS

About this trial

Last updated 5 years ago

Study ID

CYSEMS0112

Status

Completed

Type

Interventional

Phase

Phase 3

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 8 years ago

What is this trial 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.

What are the participation requirements?

Yes

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;

No

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.