Efficacy of the Combination Bismuth + Neomycin + Procaine in the Treatment of Recurrent Aphthous Ulceration

This study has been completed.
Sponsor:
Information provided by:
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
ClinicalTrials.gov Identifier:
NCT00857688
First received: March 6, 2009
Last updated: February 22, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Aphtous Ulcers
Drug: Bismu-Jet
Other: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by L.A.L Clinica Pesquisa e Desenvolvimento Ltda.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • safety will be assessed by the incidence of adverse reactions [ Time Frame: V0 - 1st day, V1 - 3st day, V2 - 7th day, V3 - 14th day ] [ Designated as safety issue: Yes ]

Enrollment: 100
Study Start Date: May 2011
Study Completion Date: November 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 - Test
Patients will recieve the association.
Drug: Bismu-Jet
Bismuth sodium tartrate, neomycin sulfate, procain hydrocloride
Placebo Comparator: 2
Placebo: Menthol, saccharin sodium, propylene glycol, sodium hydroxide, glycerol, ethyl alcohol, water
Other: Placebo
Placebo: Menthol, saccharin sodium, propylene glycol, sodium hydroxide, glycerol, ethyl alcohol, water

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

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00857688

Locations
Brazil
LAL Clinica Pesquisa e Desenvolvimento Ltda
Valinhos, SP, Brazil, 13270000
Sponsors and Collaborators
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
  More Information

No publications provided

Responsible Party: Alexandre FRederico, LAL Clinica
ClinicalTrials.gov Identifier: NCT00857688     History of Changes
Other Study ID Numbers: BNPEMS0209
Study First Received: March 6, 2009
Last Updated: February 22, 2013
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by L.A.L Clinica Pesquisa e Desenvolvimento Ltda.:
aphtous
bismuth
procain
neomycin
Efficacy of the Association in Treatment of Aphtous

Additional relevant MeSH terms:
Ulcer
Pathologic Processes
Procaine
Bismuth
Neomycin
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Antacids
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on April 14, 2014