Efficacy Study of Acriflavine Hydrochloride + Methenamine + Methylthioninium Chloride vs Placebo for the Rapid Relief of Symptoms Urinary Tract Infection
Overview[ - collapse ][ - ]
| 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. |
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| Condition | Lower Urinary Tract Infection |
| Intervention | Drug: Acriflavine hydrochloride, Methenamine, Methylthioninium chloride Drug: Placebo to Acriflavine hydrochloride, Methenamine, Methylthioninium chloride |
| Phase | Phase 3 |
| Sponsor | EMS |
| Responsible Party | EMS |
| ClinicalTrials.gov Identifier | NCT01657448 |
| First Received | August 2, 2012 |
| Last Updated | August 15, 2012 |
| Last verified | August 2012 |
Tracking Information[ + expand ][ + ]
| First Received Date | August 2, 2012 |
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| Last Updated Date | August 15, 2012 |
| Start Date | March 2013 |
| Estimated Primary Completion Date | August 2013 |
| Current 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. |
| Current 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. |
Descriptive Information[ + expand ][ + ]
| Brief Title | Efficacy Study of Acriflavine Hydrochloride + Methenamine + Methylthioninium Chloride vs Placebo for the Rapid Relief of Symptoms Urinary Tract Infection |
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| 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 |
| Brief Summary | 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. |
| 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. |
| Study Type | Interventional |
| Study Phase | Phase 3 |
| Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment |
| Condition | Lower Urinary Tract Infection |
| Intervention | Drug: Acriflavine hydrochloride, Methenamine, Methylthioninium chloride • Ingesting two (02) drives the drug with a glass of water, 8 by 8 hours for 3 days 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 |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Not yet recruiting |
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| Estimated Enrollment | 140 |
| Estimated Completion Date | August 2013 |
| Estimated Primary Completion Date | June 2013 |
| Eligibility 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. |
| Gender | Female |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Contact: FELIPE PINHO, MD + 55 19 9212 7964 felipe.pinho@ems.com.br |
| Location Countries | Brazil |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01657448 |
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| Other Study ID Numbers | CYSEMS0112 |
| Has Data Monitoring Committee | Yes |
| Information Provided By | EMS |
| Study Sponsor | EMS |
| Collaborators | Not Provided |
| Investigators | Principal Investigator: Ulisses Magalhães Antunes da Rocha, MD CAEP - Centro Avançado de Estudos e Pesquisa |
| Verification Date | August 2012 |
Locations[ + expand ][ + ]
| CAEP - Centro Avançado de Estudos e Pesquisa | Campinas, São Paulo, Brazil, 13.087-567 Principal Investigator: Ulisses Magalhães Antunes da Rocha, MdNot yet recruiting |
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