Efficacy Study of Methenamine + Methylthioninium Chloride vs Phenazopyridine for the Symptomatic … (NCT01657448) | Clinical Trial Compass
CompletedPhase 3
Efficacy Study of Methenamine + Methylthioninium Chloride vs Phenazopyridine for the Symptomatic Control of Dysuria
Brazil316 participantsStarted 2016-06-27
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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.
What they're measuring
1
Efficacy of treatment in the symptomatic relief of dysuria