Aphtous UlcersPhase 3NCT00857688
Efficacy of the Combination Bismuth + Neomycin + Procaine in the Treatment of Recurrent Aphthous Ulceration
A Phase 3 study testing Bismu-Jet in people with Aphtous Ulcers, run by Azidus Brasil at 1 site in Brazil.
Trial summary
To evaluate the efficacy of the product Bismu-Jet ® (bismuth tartrate and sodium, neomycin sulfate and procaine hydrochloride) produced by EMS S / A compared to placebo in reducing the signs and symptoms resulting from UAR in patients of both sexes, with age over 12 years. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aphtous Ulcers
- What is being tested?
- Bismu-Jet
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteBrazil
- Study dates
- May 2011to Nov 2011
- 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 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Consistency with the purposes of the study and all topics of FICT;
- Age above 12 years;
- Both sexes;
- Diagnosis of type UAR minor
Who cannot join
- Use of nutritional supplements such as iron, folic acid and vitamins of the B complex;
- immunocompromised;
- systemic diseases (endocrine-metabolic);
- rheumatic diseases;
- Pregnancy and lactation;
- Use of topical or systemic corticosteroids;
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- UAR type major;
- UAR type Herpetiformis;
- UAR over 48 hours of development;
- Background allergic to any components of the formula.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
LAL Clinica Pesquisa e Desenvolvimento Ltda
Valinhos, São Paulo, 13270000
About this study
Official title: Randomized Clinical Study to Evaluate the Effectiveness and Safety of the Drug Topic Bismu-Jet ® (Bismuth Tartrate, Neomycin Sulphate and Procaine Hydrochloride) Compared to Placebo in Improvement of Signs and Symptoms of Ulcerations Caused Disease.
To evaluate the efficacy of the product Bismu-Jet ® (bismuth tartrate and sodium, neomycin sulfate and procaine hydrochloride) produced by EMS S / A compared to placebo in reducing the signs and symptoms resulting from UAR in patients of both sexes, with age over 12 years.
Read the detailed description
The period of practical study will be conducted at the Center for Orofacial Rehabilitation Aesthetics, located in Campinas-SP, where there are several beds and a large number of people served by dentists attending post-graduate, under the supervision of Dr. Claudio Azenha. Thus, patients are instructed to find the center if they experience the first signs of UARs.
Will be included only where the top of the table has not extrapolated 48 hours. These patients will be referred to the visit of screening and early treatment (day 0 - Visit 01). At a screening visit will be informed all the relevant aspects of research, enabling the patient judge the feasibility of their participation in the study. After signing the Informed Consent, patients will be randomized and will receive one of the treatments. This consultation will be a clinical examination where the examiner will tell the lesions and measure the size of each. Besides the clinical examination there is a subjective test, in which the patient must consider the intensity of pain you're feeling at that moment, using the visual analogue scale (VAS). The drug will be administered by the investigator, the patient showing the correct way of administration. After 15 minutes, the pain will be measured again, using the VAS.
After three days, patients should return for the 02 tour, which will be clinically evaluated and will be assessed for intensity of pain, in addition to the reporting of adverse events. The same procedures will be repeated in the return of seven days (Visit 03). This visit some patients may receive high clinic.
The study will be finalized after 14 days of treatment (Visit 04), when patients must return to the office to the final evaluations, as will high or be exempted from the clinical study.
Patients who do not have improvement in time, receive replacement therapy funded by the sponsor and provided by waxen, according to the needs of each individual case, judged by expert researchers.
- Conditions
- Aphtous Ulcers
- Being tested
- Bismu-Jet, Placebo
- Keywords
- aphtous, bismuth, procain, neomycin, Efficacy of the Association in Treatment of Aphtous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bismu-JetDrug
Bismuth sodium tartrate, neomycin sulfate, procain hydrocloride
PlaceboOther
Placebo: Menthol, saccharin sodium, propylene glycol, sodium hydroxide, glycerol, ethyl alcohol, water
| Study group | Role | What they receive |
|---|---|---|
| 1 - Test | Experimental | Patients will recieve the association. Receives: Drug: Bismu-Jet |
| 2 | Placebo comparator | Placebo: Menthol, saccharin sodium, propylene glycol, sodium hydroxide, glycerol, ethyl alcohol, water Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The pain will be assessed by visual analogue scale. Will evaluate the size of the lesion using a ruler created specifically for this study The number of lesions will be evaluated by counting.
Measured: V0 - 1st day, V1 - 3st day, V2 - 7th day, V3 - 14th day
Secondary outcomes (1)
safety will be assessed by the incidence of adverse reactions
Measured: V0 - 1st day, V1 - 3st day, V2 - 7th day, V3 - 14th day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2009 (estimated)
- Study startMay 2011
- Primary completionJun 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aphtous UlcersStudies 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azidus Brasil
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00857688
- Sponsor's protocol ID
- BNPEMS0209
- Status last verified
- Feb 2013
- First submitted
- 6 Mar 2009
- Last updated
- 25 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Study to Evaluate the Effectiveness and Safety of the Drug Topic Bismu-Jet ® (Bismuth Tartrate, Neomycin Sulphate and Procaine Hydrochloride) Compared to Placebo in Improvement of Signs and Symptoms of Ulcerations Caused Disease.
- ClinicalTrials.gov ID
- NCT00857688
- Acronym / sponsor ID
- BNPEMS0209
- Conditions
- Aphtous Ulcers
- Keywords
- aphtous, bismuth, procain, neomycin, Efficacy of the Association in Treatment of Aphtous
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Azidus BrasilIndustry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Jun 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 9 Mar 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.
To evaluate the efficacy of the product Bismu-Jet ® (bismuth tartrate and sodium, neomycin sulfate and procaine hydrochloride) produced by EMS S / A compared to placebo in reducing the signs and symptoms resulting from UAR in patients of both sexes, with age over 12 years.
Detailed description
The period of practical study will be conducted at the Center for Orofacial Rehabilitation Aesthetics, located in Campinas-SP, where there are several beds and a large number of people served by dentists attending post-graduate, under the supervision of Dr. Claudio Azenha. Thus, patients are instructed to find the center if they experience the first signs of UARs.
Will be included only where the top of the table has not extrapolated 48 hours. These patients will be referred to the visit of screening and early treatment (day 0 - Visit 01). At a screening visit will be informed all the relevant aspects of research, enabling the patient judge the feasibility of their participation in the study. After signing the Informed Consent, patients will be randomized and will receive one of the treatments. This consultation will be a clinical examination where the examiner will tell the lesions and measure the size of each. Besides the clinical examination there is a subjective test, in which the patient must consider the intensity of pain you're feeling at that moment, using the visual analogue scale (VAS). The drug will be administered by the investigator, the patient showing the correct way of administration. After 15 minutes, the pain will be measured again, using the VAS.
After three days, patients should return for the 02 tour, which will be clinically evaluated and will be assessed for intensity of pain, in addition to the reporting of adverse events. The same procedures will be repeated in the return of seven days (Visit 03). This visit some patients may receive high clinic.
The study will be finalized after 14 days of treatment (Visit 04), when patients must return to the office to the final evaluations, as will high or be exempted from the clinical study.
Patients who do not have improvement in time, receive replacement therapy funded by the sponsor and provided by waxen, according to the needs of each individual case, judged by expert researchers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 - Test | Experimental | Drug: Bismu-JetPatients will recieve the association. |
| 2 | Placebo comparator | Other: PlaceboPlacebo: Menthol, saccharin sodium, propylene glycol, sodium hydroxide, glycerol, ethyl alcohol, water |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Consistency with the purposes of the study and all topics of FICT;
- Age above 12 years;
- Both sexes;
- Diagnosis of type UAR minor
Key exclusion criteria (10 listed)
- Use of nutritional supplements such as iron, folic acid and vitamins of the B complex;
- immunocompromised;
- systemic diseases (endocrine-metabolic);
- rheumatic diseases;
- Pregnancy and lactation;
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 |
|---|---|---|
| Bismu-JetBismuth sodium tartrate, neomycin sulfate, procain hydrocloride | Drug | 1 - Test |
| PlaceboPlacebo: Menthol, saccharin sodium, propylene glycol, sodium hydroxide, glycerol, ethyl alcohol, water | Other | 2 |
Primary outcome
The pain will be assessed by visual analogue scale. Will evaluate the size of the lesion using a ruler created specifically for this study The number of lesions will be evaluated by counting.
Time frame: V0 - 1st day, V1 - 3st day, V2 - 7th day, V3 - 14th day
1 secondary outcome
safety will be assessed by the incidence of adverse reactions
Time frame: V0 - 1st day, V1 - 3st day, V2 - 7th day, V3 - 14th day
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 25 Feb 2013.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bismu-Jet in people with Aphtous Ulcers, run by Azidus Brasil at 1 site 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 4 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 25 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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?
The pain will be assessed by visual analogue scale. Will evaluate the size of the lesion using a ruler created specifically for this study The number of lesions will be evaluated by counting. (time frame: V0 - 1st day, V1 - 3st day, V2 - 7th day, V3 - 14th day). 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 25 Feb 2013.