search
Back to results

Safety, Galenic Acceptability and Efficacy of GV-328 Lozenges in Children With Oral Aphthosis

Primary Purpose

Aphthous Stomatitis

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
GV-328
Sponsored by
Universitat Internacional de Catalunya
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aphthous Stomatitis focused on measuring aphthous lesion, hyaluronic acid

Eligibility Criteria

3 Years - 13 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Universitat Internacional de Catalunya

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

GV-328

Arm Description

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

The degree of functional limitation and edema in the marginal mucosa were measured using a Likert scale.
(0-absent, 1-mild, 2-moderate, 3-intense, 4-very intense).

Full Information

First Posted
December 11, 2020
Last Updated
January 29, 2021
Sponsor
Universitat Internacional de Catalunya
search

1. Study Identification

Unique Protocol Identification Number
NCT04677062
Brief Title
Safety, Galenic Acceptability and Efficacy of GV-328 Lozenges in Children With Oral Aphthosis
Official Title
Safety, Galenic Acceptability and Efficacy of GV-328 Lozenges in Children With Oral Aphthosis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
June 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitat Internacional de Catalunya

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Prospective study carried out in the Pediatric Dentistry Department of the International University of Catalonia. The sample was made up of children between 3 and 13 years old. Baseline pain status, functional limitation, edema and lesion diameter were evaluated. The treatment lasted 4 days. The parents recorded the intensity of the pain and the number of pills provided daily. Statistical significance was accepted with p≤0.05 and a 95% confidence interval. A total sample of 33 patients, 11 boys (33 %) and 22 girls (67 %) was obtained. The average age of the children was 7.8 years (SD: 1.41). Numerical variables referring to pain, inflammation and edema presented statistically significant improvements (p-value <0.05). Healing efficacy was demonstrated in 13 cases (39 %) and only 3 cases (9 %) reported poor taste acceptability.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphthous Stomatitis
Keywords
aphthous lesion, hyaluronic acid

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GV-328
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
GV-328
Intervention Description
Patients with GV-328 treatment
Primary Outcome Measure Information:
Title
The level of pain was measured on the Wong-Baker Faces Scale (WBFS)
Description
It consists of a 6-point scale that ranges from 0 (no pain) to 5 (excruciating pain).
Time Frame
4 DAYS
Secondary Outcome Measure Information:
Title
The degree of functional limitation and edema in the marginal mucosa were measured using a Likert scale.
Description
(0-absent, 1-mild, 2-moderate, 3-intense, 4-very intense).
Time Frame
4 DAYS
Other Pre-specified Outcome Measures:
Title
The baseline size of the main lesion was also classified according to its diameter
Description
<0.5 cm, 0.5-1.0cm or> 1.0 cm.
Time Frame
4 DAYS

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients aged 3-13 years. Children who presented canker sores. Exclusion Criteria: Patients who presented canker sores with 48 h of evolution. Patients with diabetic disorders.
Facility Information:
Facility Name
Universitat Internacional de Catalunya
City
Sant Cugat del Vallès
State/Province
Barcelona
ZIP/Postal Code
08195
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

Safety, Galenic Acceptability and Efficacy of GV-328 Lozenges in Children With Oral Aphthosis

We'll reach out to this number within 24 hrs