A Phase 4 interventional study of Methenamine + Methylthioninium and Methenamine + Methylthioninium + Acriflavine + Atropa belladona in Urinary Tract Infections, sponsored by Fundação Educacional Serra dos Órgãos. Completed at 1 site in Brazil. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-12-14.
Sponsored by Fundação Educacional Serra dos Órgãos · Phase 4, Interventional, and Treatment
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.
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.
803 studies on the registry are indexed under Urinary Tract Infections; 133 are open to participants now.
This study's enrollment of 284 is above the median of 131 across 560 interventional studies indexed under Urinary Tract Infections.
Browse Urinary Tract Infections studies →Fundação Educacional Serra dos Órgãos is the lead sponsor of 10 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Dosage: Methenamine (120mg) + Methylthioninium (20mg) Dosage form: coated tablets Frequency: 2 coated tablets twice daily Duration: 6 days
Drug: Methenamine + Methylthioninium · Drug: Antibiotics
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 · Drug: Antibiotics
Drug page: Methenamine
Methenamine + Methylthioninium
Also known as: methenamine + methylene blue
Methenamine + Methylthioninium + Acriflavine + Atropa belladona
Also known as: methenamine + methylene blue + acriflavine + A. belladona
Antibiotics based on individual subjects urine culture / antibiogram
Also known as: Antimicrobials
Urination regularity
Percentage of subjects presenting improvement in cystitis symptoms in the "Urination Regularity" domain of the UTISA at Visit 2.
Time frame: Following three days of treatment with urinary antiseptics
Total UTISA score
Evolution of total UTISA score at end of study compared to pretreatment in each treatment group
Time frame: From pretreatment to final visit, total of 6 days of treatment
UTISA question # 9
Percentage of subjects with improvement in UTISA question 9 at Visit 2 in each treatment group
Time frame: At Visit 2, after 3 days of treatment
Adverse events
Incidence of study drug-related adverse events in each treatment group
Time frame: From pretreatment to final visit, total of 6 days of treatment
Problems with Urination at Visit 2
Evolution of UTISA domain "Problems with Urination" in each treatment Group
Time frame: After 3 days of treatment
Problems with Urination at Visit 3
Evolution of UTISA domain "Problems with Urination" in each treatment Group
Time frame: After 6 days of treatment
Pain Associated with UTI at Visit 2
Evolution of UTISA domain "Pain Associated with UTI" in each treatment Group
Time frame: After 3 days of treatment
Pain Associated with UTI at Visit 3
Evolution of UTISA domain "Pain Associated with UTI" in each treatment Group
Time frame: After 6 days of treatment
Blood in Urine at Visit 2
Evolution of UTISA domain "Blood in Urine" in each treatment Group
Time frame: After 3 days of treatment
Blood in Urine at Visit 3
Evolution of UTISA domain "Blood in Urine" in each treatment Group
Time frame: After 6 days of treatment
Plan to share: No
No publications or documents are linked to this record.
Ran from Mar 2018 to primary completion in May 2019, 13 months.
Of 44 non-industry phase 4 interventional studies under Urinary Tract Infections, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 50. This study's 13 months is below that.
Counting every sponsor, half of 50 studies reached it within 37 months; a quarter within 22 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Methenamine
Fundação Educacional Serra dos Órgãos