DysuriaPhase 3NCT01657448
Efficacy Study of Methenamine + Methylthioninium Chloride vs Phenazopyridine for the Symptomatic Control of Dysuria
A Phase 3 study testing Methenamine and Methylthioninium chloride and Phenazopyridine in people with Dysuria, run by EMS at 4 sites in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dysuria
- What is being tested?
- Methenamine and Methylthioninium chloride and Phenazopyridine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 316 participants
- Where
- 4 sitesBrazil
- Study dates
- 27 Jun 2016to 22 Dec 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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;
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- 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.
Trial locations and contacts
4 sites in 1 country.
Brazil4 sites
Centro de Medicina Reprodutiva Carlos Isaia Filho Ltda
Porto Alegre, Rio Grande do Sul
Marcio Antonio Pereira Clinica de Endocrinologia
São José dos Campos, São Paulo
AFIP
São Paulo
Savmed Clinica Médica S/C Ltda.
São Paulo
About this study
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
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.
Read the 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.
- Conditions
- Dysuria
- Being tested
- Methenamine and Methylthioninium chloride, Phenazopyridine
- Keywords
- Symptom of Dysuria
- Medical subject headings
- Dysuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methenamine and Methylthioninium chlorideDrug
- Ingesting two (02) tablets of the drug with a glass of water, every 8 hours for 3 days
PhenazopyridineDrug
Also called Pyridium
- Ingesting two (02) tablets of the drug with a glass of water, every 8 hours for 3 days
| Study group | Role | What they receive |
|---|---|---|
| Methenamine, Methylthioninium | Experimental | Not described Receives: Drug: Methenamine and Methylthioninium chloride |
| Phenazopyridine | Active comparator | Not described Receives: Drug: Phenazopyridine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of treatment in the symptomatic relief of dysuria
Measured: 3 days
Secondary outcomes (1)
Safety of the study medication
To assess the safety of the study medication on the occurrence, type, intensity and frequency of adverse reactions during the treatment period.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2012 (estimated)
- Study start27 Jun 2016
- Primary completion21 Nov 2016
- Study completion22 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysuriaStudies of the same condition, open and under way.
- More trials run by EMSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 316 participants (actual)
Sponsor and investigators
- Lead sponsor
- EMS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01657448
- Sponsor's protocol ID
- CYSEMS0112
- Status last verified
- Jul 2020
- First submitted
- 2 Aug 2012
- Last updated
- 7 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01657448
- Acronym / sponsor ID
- CYSEMS0112
- Conditions
- Dysuria
- Keywords
- Symptom of Dysuria
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 316 participants (actual)
- Lead sponsor
- EMSIndustry (pharma, biotech, devices)
- Study start
- 27 Jun 2016 (actual)
- Primary completion
- 21 Nov 2016 (actual)
- Study completion
- 22 Dec 2017 (actual)
- First posted
- 6 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methenamine, Methylthioninium | Experimental | Drug: Methenamine and Methylthioninium chloride |
| Phenazopyridine | Active comparator | Drug: Phenazopyridine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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;
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methenamine and Methylthioninium chloride• Ingesting two (02) tablets of the drug with a glass of water, every 8 hours for 3 days | Drug | Methenamine, Methylthioninium |
| PhenazopyridineAlso: Pyridium• Ingesting two (02) tablets of the drug with a glass of water, every 8 hours for 3 days | Drug | Phenazopyridine |
Primary outcome
Efficacy of treatment in the symptomatic relief of dysuria
Time frame: 3 days
1 secondary outcome
Safety of the study medication
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Methenamine and Methylthioninium chloride and Phenazopyridine in people with Dysuria, run by EMS at 4 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of treatment in the symptomatic relief of dysuria (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2020.