NCT04677062

Brief Summary

The aim of the study was to assess the safety, acceptability, and efficacy of product GV-328 for the treatment of childhood oral aphthous lesion.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2017

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

December 11, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 21, 2020

Completed
Last Updated

February 1, 2021

Status Verified

January 1, 2021

Enrollment Period

1.7 years

First QC Date

December 11, 2020

Last Update Submit

January 29, 2021

Conditions

Aphthous Stomatitis

Keywords

aphthous lesionhyaluronic acid

Outcome Measures

Primary Outcomes (1)

  • The level of pain was measured on the Wong-Baker Faces Scale (WBFS)

    It consists of a 6-point scale that ranges from 0 (no pain) to 5 (excruciating pain).

    4 DAYS

Secondary Outcomes (1)

  • The degree of functional limitation and edema in the marginal mucosa were measured using a Likert scale.

    4 DAYS

Other Outcomes (1)

  • The baseline size of the main lesion was also classified according to its diameter

    4 DAYS

Study Arms (1)

GV-328

EXPERIMENTAL

The treatment should be carried out for 4 days. Children between 3 and 6 years old had to consume 4 pills a day, children between 7 and 10 years old 5 pills, and children between 11 and 13 years old up to 6 pills. The patient had to slowly thin the tablet in the mouth, maintaining direct contact with the area to be treated. The study consisted of 2 visits, one initial and one final. In the initial visit , the documentation (informed consent) and the treatment were delivered. During this visit, baseline assessments of pain level, functional limitation, marginal mucosal edema, and lesion size were recorded. In addition, a photograph of the area to be treated was taken. Parents were also given a chart, in which they had to record the intensity of pain daily using the Wong-Baker face scale.

Drug: GV-328

Interventions

GV-328DRUG

Patients with GV-328 treatment

GV-328

Eligibility Criteria

Age3 Years - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Patients aged 3-13 years.
  • Children who presented canker sores.

You may not qualify if:

  • Patients who presented canker sores with 48 h of evolution.
  • Patients with diabetic disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitat Internacional de Catalunya

Sant Cugat del Vallès, Barcelona, 08195, Spain

Location

MeSH Terms

Conditions

Stomatitis, Aphthous

Condition Hierarchy (Ancestors)

StomatitisMouth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Jefe departamento de odontopedaitria

Study Record Dates

First Submitted

December 11, 2020

First Posted

December 21, 2020

Study Start

November 1, 2017

Primary Completion

June 30, 2019

Study Completion

June 30, 2019

Last Updated

February 1, 2021

Record last verified: 2021-01

Locations

ES(1)