Dysuria
Conditions
Keywords
Symptom of Dysuria
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.
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.
Interventions
DRUGMethenamine and Methylthioninium chloride
• Ingesting two (02) tablets of the drug with a glass of water, every 8 hours for 3 days
DRUGPhenazopyridine
• Ingesting two (02) tablets of the drug with a glass of water, every 8 hours for 3 days
Sponsors
EMS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy of treatment in the symptomatic relief of dysuria | 3 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Brazil
Outcome results
None listed