DysuriaPhase 3E01OSMPLS0108NCT00969254

Study to Assess the Efficacy and Safety of "Pílulas de Lussen®" Compared to the Pyridium® in the Symptomatic Control of Dysuria

A Phase 3 study testing Pílulas de Lussen and Pyridium® in people with Dysuria, run by Laboratorios Osorio de Moraes Ltda..

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Clinical Study, prospective, comparative, randomized, double-dummy entry with random from a total of 80 patients, 40 patients will receive the test medication (Pílulas de Lussen®) plus placebo and 40 patients will receive the comparative (Pyridium®) plus placebo. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Dysuria
What is being tested?: Pílulas de Lussen and Pyridium®
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: No sites listed yet
Study dates: Dec 2009to Mar 2010
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 over the age of 18 years;
Patients with symptoms of dysuria characterized by pain/burning sensation in the lower urinary tract and discomfort in urination;
Patients who are female and are of childbearing age should use reliable method of contraception and have negative pregnancy test.
Patients who consent to participate in the study.

Who cannot join

Patients with sensitivity to any component of the formula;
Patients pregnant or lactating;
Patients with a history of glaucoma, heart failure, cardiac arrhythmias, prostatic hypertrophy, paralytic ileus or pyloric stenosis;
Patients with menorrhagia or heavy menstrual periods;
Patients who need to use antibiotics or chemotherapy;
Patients who can not follow the procedures shown in this Clinical Protocol.

Trial locations and contacts

No sites are listed yet.

Dagoberto Brandão contact

55 11 3673 3763

dagoberto@phcbrasil.com.br

About this study

Official title: Phase III Clinical Study, Prospective, Multicenter, Double-blind, Randomized, Double-dummy to Assess the Efficacy and Safety of "Pílulas de Lussen®" Compared to the Pyridium® in the Symptomatic Control of Dysuria

Read the detailed description

Phase III Clinical Study, prospective, multicenter, double-blind, randomized, double-dummy to assess the efficacy and safety of "Pílulas de Lussen®" compared to the Pyridium® in the symptomatic control of dysuria in 80 patients of either sex or race, older than 18 years, with symptoms of dysuria, 40 patients will receive the test medication (Pílulas de Lussen®) plus placebo and 40 patients will receive the comparative (Pyridium®) plus placebo to evaluate the effectiveness and tolerability of 'Pílulas de Lussen' for symptomatic relief of dysuria.

Conditions: Dysuria
Being tested: Pílulas de Lussen, Pyridium®
Keywords: Pílulas de Lussen, Efficacy, Safety, Dysuria, Symptomatic control
Medical subject headings: Dysuria

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Pílulas de LussenDrug
Take one dragee of drug A* and one dragee of drug B** every 8 hours for three days.
- Drug A: Pílulas de Lussen®
** Drug B: placebo.
Pyridium®Drug
Take one dragee of drug A* and one dragee of drug B** every 8 hours for three days.
- Drug A: Pyridium®
** Drug B: placebo.

Study groups in NCT00969254
Study group	Role	What they receive
Pílulas de Lussen	Experimental	Take one dragee of drug A* and one dragee of drug B** every 8 hours for three days. * Drug A: Pílulas de Lussen® ** Drug B: placebo. Receives: Drug: Pílulas de Lussen
Pyridium®	Active comparator	Take one dragee of drug A* and one dragee of drug B** every 8 hours for three days. * Drug A: Pyridium® ** Drug B: placebo. Receives: Drug: Pyridium®

What is being measured

The primary outcome is the main question the study is designed to answer.

Visual Analogic Scale and opinion of the investigator.
Measured: 3 days

Secondary outcomes (1)

Of adverse events related to study medication by the Naranjo Algorithm.
Measured: 3 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2009Mar 2010

First posted1 Sep 2009 (estimated)
Study startDec 2009
Primary completionFeb 2010 (estimated)
Study completionMar 2010 (estimated)

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.
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: Double blind
Who is masked: Participant, Investigator
Enrolment: 80 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00969254
Sponsor's protocol ID: E01-OSM-PLS-01-08
Acronym: E01OSMPLS0108
Status last verified: Aug 2009
First submitted: 31 Aug 2009
Last updated: 1 Sep 2009
Results posted: No
Data monitoring committee: No

Want to know more?

Dagoberto Brandão

55 11 3673 3763

dagoberto@phcbrasil.com.br

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Dysuria trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase III Clinical Study, Prospective, Multicenter, Double-blind, Randomized, Double-dummy to Assess the Efficacy and Safety of "Pílulas de Lussen®" Compared to the Pyridium® in the Symptomatic Control of Dysuria
ClinicalTrials.gov ID: NCT00969254
Acronym / sponsor ID: E01OSMPLS0108 / E01-OSM-PLS-01-08
Conditions: Dysuria
Keywords: Pílulas de Lussen, Efficacy, Safety, Dysuria, Symptomatic control
Phase: Phase 3
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 80 participants (estimated)
Lead sponsor: Laboratorios Osorio de Moraes Ltda.Industry (pharma, biotech, devices)
Study start: Dec 2009
Primary completion: Feb 2010 (estimated)
Study completion: Mar 2010 (estimated)
First posted: 1 Sep 2009 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Pílulas de Lussen	Experimental	Drug: Pílulas de LussenTake one dragee of drug A* and one dragee of drug B** every 8 hours for three days. * Drug A: Pílulas de Lussen® ** Drug B: placebo.
Pyridium®	Active comparator	Drug: Pyridium®Take one dragee of drug A* and one dragee of drug B** every 8 hours for three days. * Drug A: Pyridium® ** Drug B: placebo.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Patients over the age of 18 years;
Patients with symptoms of dysuria characterized by pain/burning sensation in the lower urinary tract and discomfort in urination;
Patients who are female and are of childbearing age should use reliable method of contraception and have negative pregnancy test.
Patients who consent to participate in the study.

Key exclusion criteria (6 listed)

Patients with sensitivity to any component of the formula;
Patients pregnant or lactating;
Patients with a history of glaucoma, heart failure, cardiac arrhythmias, prostatic hypertrophy, paralytic ileus or pyloric stenosis;
Patients with menorrhagia or heavy menstrual periods;
Patients who need to use antibiotics or chemotherapy;

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
Pílulas de LussenTake one dragee of drug A* and one dragee of drug B** every 8 hours for three days. * Drug A: Pílulas de Lussen® ** Drug B: placebo.	Drug	Pílulas de Lussen
Pyridium®Take one dragee of drug A* and one dragee of drug B** every 8 hours for three days. * Drug A: Pyridium® ** Drug B: placebo.	Drug	Pyridium®

Primary outcome

Visual Analogic Scale and opinion of the investigator.
Time frame: 3 days

1 secondary outcome

Of adverse events related to study medication by the Naranjo Algorithm.
Time frame: 3 days

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2009.

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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.

Dagoberto Brandão contact

55 11 3673 3763

dagoberto@phcbrasil.com.br

Lúcia Hime principal investigator

Universidade de Santo Amaro (UNISA)

Nabil Ghorayeb principal investigator

Clínica Nabil Ghorayeb

Patrícia Smith principal investigator

Clínica Nabil Ghorayeb

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pílulas de Lussen and Pyridium® in people with Dysuria, run by Laboratorios Osorio de Moraes Ltda..

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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 1 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.

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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Dagoberto Brandão (55 11 3673 3763, dagoberto@phcbrasil.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual Analogic Scale and opinion of the investigator. (time frame: 3 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00969254.

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 1 Sep 2009.