Efficacy of the Combination Bismuth + Neomycin + Procaine in the Treatment of Recurrent Aphthous Ulceration
Information source: L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Aphtous Ulcers
Intervention: Bismu-Jet (Drug); Placebo (Other)
Phase: Phase 3
Status: Not yet recruiting
Sponsored by: L.A.L Clinica Pesquisa e Desenvolvimento Ltda. Overall contact:
Humberto Vilugron, Coordinator, Phone: 55 19 3829-3822, Email: humberto@lalclinica.com.br
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.
Clinical Details
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.
Study design: Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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.
Secondary outcome: safety will be assessed by the incidence of adverse reactions
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.
Eligibility
Minimum age: 12 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Consistency with the purposes of the study and all topics of FICT;
- Age above 12 years;
- Both sexes;
- Diagnosis of type UAR minor
Exclusion Criteria:
- 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;
- UAR type major;
- UAR type Herpetiformis;
- UAR over 48 hours of development;
- Background allergic to any components of the formula.
Locations and Contacts
Humberto Vilugron, Coordinator, Phone: 55 19 3829-3822, Email: humberto@lalclinica.com.br
LAL Clinica Pesquisa e Desenvolvimento Ltda, Valinhos, SP 13270000, Brazil
Additional Information
Starting date: March 2009
Last updated: March 27, 2009
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