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

Aphthous Stomatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04677062
• Other study ID #: UIC-ODP-VIÑAS
• Status: Completed
• Phase: N/A
• Start date: November 1, 2017
• Est. completion date: June 30, 2019

Study information

• Verified date: January 2021
• Source: Universitat Internacional de Catalunya
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 13 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aphthous Stomatitis
• Stomatitis
• Stomatitis, Aphthous

Intervention

Drug:
• GV-328
Patients with GV-328 treatment

Locations

Country	Name	City	State
Spain	Universitat Internacional de Catalunya	Sant Cugat del Vallès	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Universitat Internacional de Catalunya

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The baseline size of the main lesion was also classified according to its diameter	<0.5 cm, 0.5-1.0cm or> 1.0 cm.	4 DAYS
Primary	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	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).	4 DAYS