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Clinical Assessment of Urinary Antiseptics Methenamine and Methylthioninium in Recurrent Cystitis

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ClinicalTrials.gov Identifier: NCT03379389
Recruitment Status : Recruiting
First Posted : December 20, 2017
Last Update Posted : May 3, 2018
Sponsor:
Collaborator:
Laboratório Gross S.A.
Information provided by (Responsible Party):
Carlos Pereira Nunes, Fundação Educacional Serra dos Órgãos

Brief Summary:
This is a double-blind, randomized, double-dummy, comparative study in parallel groups of subjects presenting with recurrent cystitis (≥2 episodes within the past 6 months). Subjects will be randomized and treated with one of two presentations of urinary antiseptics containing methenamine and methylthioninium for three days, followed by three days of antibiotic therapy as determined by urine culture and antibiogram. This study aims to assess the efficacy and safety of each treatment.

Condition or disease Intervention/treatment Phase
Urinary Tract Infections Drug: Methenamine + Methylthioninium Drug: Methenamine + Methylthioninium + Acriflavine + Atropa belladona Drug: Antibiotics Phase 4

Detailed Description:
This is a double-blind, randomized, double-dummy, comparative study in parallel groups of subjects presenting with recurrent cystitis (≥2 episodes within the past 6 months). After initial evaluations including urine culture and antibiogram, a total of 284 subjects will be randomized and treated with one of two presentations of urinary antiseptics containing methenamine and methylthioninium for six days. After three days of treatment, subjects will return to the study center and antibiotic therapy based on the results of the urine culture and antibiogram will be initiated for each subject, to be continued for the remaining three days of the treatment period. Efficacy assessments will include the UTISA (Urinary Tract Infection Symptoms Assessment Questionnaire) together with a global assessment by the investigator. Safety assessments will include monitoring of adverse events and laboratory tests carried out at each of the three study visits.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 284 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Assessment of Urinary Antiseptics Methenamine and Methylthioninium in Recurrent Cystitis
Actual Study Start Date : March 31, 2018
Estimated Primary Completion Date : May 1, 2019
Estimated Study Completion Date : May 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Methenamine + Methylthioninium
Dosage: Methenamine (120mg) + Methylthioninium (20mg) Dosage form: coated tablets Frequency: 2 coated tablets twice daily Duration: 6 days
Drug: Methenamine + Methylthioninium
Methenamine + Methylthioninium

Drug: Antibiotics
Antibiotics based on individual subjects urine culture / antibiogram

Active Comparator: Methenamine+Methylthioninium+Acriflavine+Atropa belladona
Dosage: Methenamine (250mg) + Methylthioninium (20mg) + Acriflavine hydrochloride (15mg) + Atropa belladonna L. (15mg) Dosage form: coated tablets Frequency: 2 coated tablets twice daily Duration: 6 days
Drug: Methenamine + Methylthioninium + Acriflavine + Atropa belladona
Methenamine + Methylthioninium + Acriflavine + Atropa belladona

Drug: Antibiotics
Antibiotics based on individual subjects urine culture / antibiogram




Primary Outcome Measures :
  1. Urination regularity [ Time Frame: Following three days of treatment with urinary antiseptics ]
    Percentage of subjects presenting improvement in cystitis symptoms in the "Urination Regularity" domain of the UTISA at Visit 2.


Secondary Outcome Measures :
  1. Total UTISA score [ Time Frame: From pretreatment to final visit, total of 6 days of treatment ]
    Evolution of total UTISA score at end of study compared to pretreatment in each treatment group

  2. UTISA question # 9 [ Time Frame: At Visit 2, after 3 days of treatment ]
    Percentage of subjects with improvement in UTISA question 9 at Visit 2 in each treatment group

  3. Adverse events [ Time Frame: From pretreatment to final visit, total of 6 days of treatment ]
    Incidence of study drug-related adverse events in each treatment group

  4. Problems with Urination at Visit 2 [ Time Frame: After 3 days of treatment ]
    Evolution of UTISA domain "Problems with Urination" in each treatment Group

  5. Problems with Urination at Visit 3 [ Time Frame: After 6 days of treatment ]
    Evolution of UTISA domain "Problems with Urination" in each treatment Group

  6. Pain Associated with UTI at Visit 2 [ Time Frame: After 3 days of treatment ]
    Evolution of UTISA domain "Pain Associated with UTI" in each treatment Group

  7. Pain Associated with UTI at Visit 3 [ Time Frame: After 6 days of treatment ]
    Evolution of UTISA domain "Pain Associated with UTI" in each treatment Group

  8. Blood in Urine at Visit 2 [ Time Frame: After 3 days of treatment ]
    Evolution of UTISA domain "Blood in Urine" in each treatment Group

  9. Blood in Urine at Visit 3 [ Time Frame: After 6 days of treatment ]
    Evolution of UTISA domain "Blood in Urine" in each treatment Group



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients of both sexes, age ≥18
  • Clinical diagnosis of recurrent cystitis (≥ 2 episodes in the past 6 months)
  • Female subject of reproductive age not pregnant, agrees to use birth control during study period
  • Subject has read, understood, signed and dated informed consent document

Exclusion Criteria:

  • History of nephritis or kidney stones
  • History of hepatic or gastrointestinal disease
  • Diabetes
  • Glaucoma
  • Female subjects: pregnancy or breastfeeding
  • History of anatomical alterations contributing to recurring cystitis on imaging exams
  • Hypersensitivity to any component of study drug

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03379389


Contacts
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Contact: Carlos P Nunes, MD (+55-21) 99461-5193 carlos.nunes@globo.com

Locations
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Brazil
Centro Universitário Serra dos Órgãos - UNIFESO Recruiting
Teresópolis, RJ, Brazil, 25964004
Contact: Carlos P Nunes, MD    2126417000    carlos.nunes@globo.com   
Sponsors and Collaborators
Fundação Educacional Serra dos Órgãos
Laboratório Gross S.A.

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Responsible Party: Carlos Pereira Nunes, Professor of Internal Medicine, Fundação Educacional Serra dos Órgãos
ClinicalTrials.gov Identifier: NCT03379389     History of Changes
Other Study ID Numbers: AUCR-01-05-17
First Posted: December 20, 2017    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Urinary Tract Infections
Infection
Urinary Bladder Diseases
Anti-Infective Agents, Urinary
Cystitis
Urologic Diseases
Anti-Bacterial Agents
Methenamine hippurate
Methenamine mandelate
Antibiotics, Antitubercular
Anti-Infective Agents, Local
Acriflavine
Methenamine
Methylene Blue
Anti-Infective Agents
Antitubercular Agents
Renal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action