NCT00857688

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started May 2011

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 6, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 9, 2009

Completed
2.1 years until next milestone

Study Start

First participant enrolled

May 1, 2011

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

February 25, 2013

Status Verified

February 1, 2013

Enrollment Period

1 month

First QC Date

March 6, 2009

Last Update Submit

February 22, 2013

Conditions

Aphtous Ulcers

Keywords

aphtousbismuthprocainneomycinEfficacy of the Association in Treatment of Aphtous

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

    V0 - 1st day, V1 - 3st day, V2 - 7th day, V3 - 14th day

Study Arms (2)

1 - Test

EXPERIMENTAL

Patients will recieve the association.

Drug: Bismu-Jet

2

PLACEBO COMPARATOR

Placebo: Menthol, saccharin sodium, propylene glycol, sodium hydroxide, glycerol, ethyl alcohol, water

Other: Placebo

Interventions

Bismu-JetDRUG

Bismuth sodium tartrate, neomycin sulfate, procain hydrocloride

1 - Test
PlaceboOTHER

Placebo: Menthol, saccharin sodium, propylene glycol, sodium hydroxide, glycerol, ethyl alcohol, water

2

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Consistency with the purposes of the study and all topics of FICT;
  • Age above 12 years;
  • Both sexes;
  • Diagnosis of type UAR minor

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LAL Clinica Pesquisa e Desenvolvimento Ltda

Valinhos, São Paulo, 13270000, Brazil

Location

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 6, 2009

First Posted

March 9, 2009

Study Start

May 1, 2011

Primary Completion

June 1, 2011

Study Completion

November 1, 2011

Last Updated

February 25, 2013

Record last verified: 2013-02

Locations

BR(1)