Efficacy Study of Acriflavine Hydrochloride + Methenamine + Methylthioninium Chloride vs Placebo for the Rapid Relief of Symptoms Urinary Tract Infection

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by EMS.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
EMS
ClinicalTrials.gov Identifier:
NCT01657448
First received: August 2, 2012
Last updated: August 15, 2012
Last verified: August 2012
  Purpose

The purpose of this study is to evaluate the efficacy of the combination of Acriflavine hydrochloride + Methenamine + Methylthioninium chloride produced by EMS S/A, using the comparator Placebo, the rapid relief of symptoms in uncomplicated lower urinary tract infection in women.


Condition Intervention Phase
Lower Urinary Tract Infection
Drug: Acriflavine hydrochloride, Methenamine, Methylthioninium chloride
Drug: Placebo to Acriflavine hydrochloride, Methenamine, Methylthioninium chloride
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Parallel Study, Double-blind, Randomized, to Evaluate the Efficacy of the Combination of Drug Versus Placebo of Drug for the Rapid Relief of Symptoms of Uncomplicated Lower Urinary Tract Infection in Women

Resource links provided by NLM:


Further study details as provided by EMS:

Primary Outcome Measures:
  • Efficacy of treatment in the rapid relief of symptoms in uncomplicated lower urinary tract infection [ Time Frame: 3 days ] [ Designated as safety issue: No ]
    Symptoms will be assessed during the first 24 hours as pollakiuria, cystalgia, dysuria, urinary urgency and odor through the report of the patient (subjective parameter) and objective evaluation through laboratory tests and urine culture Urine I, comparing, after 3 days treatment, the results between groups.


Secondary Outcome Measures:
  • Safety of the study medication [ Time Frame: 5 days ] [ Designated as safety issue: Yes ]
    To assess the safety of the study medication on the occurrence, type, intensity and frequency of adverse reactions during the treatment period.


Estimated Enrollment: 140
Study Start Date: March 2013
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Acriflavine, Methenamine, Methylthioninium Drug: Acriflavine hydrochloride, Methenamine, Methylthioninium chloride
• Ingesting two (02) drives the drug with a glass of water, 8 by 8 hours for 3 days
Placebo Comparator: Placebo to Acriflavine, Methenamine, Methylthioninium Drug: Placebo to Acriflavine hydrochloride, Methenamine, Methylthioninium chloride
• Ingesting two (02) drives the drug with a glass of water, 8 by 8 hours for 3 days

Detailed Description:
  • Open, randomized, prospective study.
  • Length of experience: 05 days.
  • 04 visits (days 1, 2, 5 and 7).
  • Evaluation of the efficacy and safety of the medication.
  • Shall be assessed for symptoms during the first 24 hours as pollakiuria, cystalgia, dysuria, urinary urgency and odor through the report of the patients (subjective parameter) and objective evaluation through laboratory tests and urine culture Urine I, comparing, after 3 days treatment, the results between the groups.
  • Shall be assessed for adverse events.
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who agree to participate by agreeing to the terms proposed in the IC;
  • Patients aged over 18 years of any ethnicity;
  • Female patients;
  • Patients with clinical diagnosis of urinary tract infection (UTI), for symptomatic UTI, uncomplicated, with onset of symptoms no more than 72 hours of visit 1;
  • Women who are using an effective method of birth control (hormonal contraceptives, IUDs, surgical sterilization), or who are postmenopausal, in addition to condom use (mandatory).

Exclusion Criteria:

  • Patients who are febrile (axillary T º: ≥ 38 ° C), with back pain or lumbar;
  • Patients with suspected STD and / or pelvic inflammatory disease;
  • Patients with complicated clinical picture of UTI-eligible or systemic antibiotic therapy intravenously;
  • Patients hospitalized and / or bedridden and / or making use of urinary probe;
  • Patients with any other infectious condition that could confound interpretation of clinical response to treatment;
  • Patients who received systemic antibiotic therapy / parenteral past 30 days;
  • 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 receiving treatment with immunosuppressants, including corticosteroids within 30 days before the study began, or who are receiving immunosuppressive treatments or who have congenital or acquired immunodeficiency known;
  • Patients who received antibiotic treatment, anthelmintic within 15 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;
  • Patients with a history of alcoholism, drug abuse, psychological or emotional problems that would invalidate the Deed of Consent or limit the ability of patients to adhere to protocol requirements;
  • Patients with any direct, familiar or not with professionals involved in conducting the study or the EMS S / A;
  • Patients with uncontrolled hypertension (blood pressure [PA] pressure> 180 mmHg or diastolic BP> 100 mmHg) at randomization or clinical hypertensive urgency;
  • Patients with a prior history of abnormal hematologic, hepatic, renal or metabolic functions;
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01657448

Contacts
Contact: FELIPE PINHO, MD + 55 19 9212 7964 felipe.pinho@ems.com.br

Locations
Brazil
CAEP - Centro Avançado de Estudos e Pesquisa Not yet recruiting
Campinas, São Paulo, Brazil, 13.087-567
Principal Investigator: Ulisses Magalhães Antunes da Rocha, Md         
Sponsors and Collaborators
EMS
Investigators
Principal Investigator: Ulisses Magalhães Antunes da Rocha, MD CAEP - Centro Avançado de Estudos e Pesquisa
  More Information

No publications provided

Responsible Party: EMS
ClinicalTrials.gov Identifier: NCT01657448     History of Changes
Other Study ID Numbers: CYSEMS0112
Study First Received: August 2, 2012
Last Updated: August 15, 2012
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by EMS:
Urinary infection

Additional relevant MeSH terms:
Infection
Communicable Diseases
Urinary Tract Infections
Urologic Diseases
Acriflavine
Methenamine hippurate
Methenamine
Methylene Blue
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Infective Agents, Urinary
Renal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 22, 2014