Clinical trial NCT01657448: Efficacy Study of Methenamine + Methylthioninium Chloride vs Phenazopyridine for the Symptomatic Control of Dysuria
Official title: Phase III, Prospective, Multicenter, Single-blind, Randomized, Superiority to Evaluate the Efficacy and Safety of Methenamine Association 250mg + Methylthioninium Chloride 20 mg Compared to Phenazopyridine 100 mg in Symptomatic Control of Dysuria
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dysuria
Keywords: Symptom of Dysuria
Lead sponsor: EMS
Sponsor class: INDUSTRY
First posted: 2012-08-06
Enrollment: 316
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Efficacy of treatment in the symptomatic relief of dysuria
timeFrame: 3 days
Secondary outcomes:
measure: Safety of the study medication
timeFrame: 7 days
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Centro de Medicina Reprodutiva Carlos Isaia Filho Ltda
state: Rio Grande Do Sul
city: São José dos Campos
country: Brazil
facility: Marcio Antonio Pereira Clinica de Endocrinologia
state: São Paulo
city: São Paulo
country: Brazil
facility: AFIP
city: São Paulo
country: Brazil
facility: Savmed Clinica Médica S/C Ltda.
Study officials:
References: