Aphthous StomatitisNCT04677062
Safety, Galenic Acceptability and Efficacy of GV-328 Lozenges in Children With Oral Aphthosis
A study testing GV-328 in people with Aphthous Stomatitis, run by Universitat Internacional de Catalunya at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 3 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Aphthous Stomatitis
- What is being tested?
- GV-328
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteSpain
- Study dates
- 1 Nov 2017to 30 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patients aged 3-13 years.
- Children who presented canker sores.
Who cannot join
- Patients who presented canker sores with 48 h of evolution.
- Patients with diabetic disorders.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Universitat Internacional de Catalunya
Sant Cugat del Vallès, Barcelona, 08195
About this study
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.
Read the 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.
- Conditions
- Aphthous Stomatitis
- Being tested
- GV-328
- Keywords
- aphthous lesion, hyaluronic acid
- Medical subject headings
- Stomatitis, Aphthous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GV-328Drug
Patients with GV-328 treatment
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: GV-328 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 4 DAYS
Secondary outcomes (1)
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).
Measured: 4 DAYS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2020
- Study start1 Nov 2017
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aphthous StomatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitat Internacional de Catalunya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francisco Guinot-Jimeno, Universitat Internacional de Catalunya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04677062
- Sponsor's protocol ID
- UIC-ODP-VIÑAS
- Status last verified
- Jan 2021
- First submitted
- 11 Dec 2020
- Last updated
- 1 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Galenic Acceptability and Efficacy of GV-328 Lozenges in Children With Oral Aphthosis
- ClinicalTrials.gov ID
- NCT04677062
- Acronym / sponsor ID
- UIC-ODP-VIÑAS
- Conditions
- Aphthous Stomatitis
- Keywords
- aphthous lesion, hyaluronic acid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Universitat Internacional de CatalunyaUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 21 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GV-328 | Experimental | Drug: GV-328The 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. |
Who may qualify
- Ages
- 3 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Patients aged 3-13 years.
- Children who presented canker sores.
Key exclusion criteria (2 listed)
- Patients who presented canker sores with 48 h of evolution.
- Patients with diabetic disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GV-328Patients with GV-328 treatment | Drug | GV-328 |
Primary outcome
The level of pain was measured on the Wong-Baker Faces Scale (WBFS)
Time frame: 4 DAYS
It consists of a 6-point scale that ranges from 0 (no pain) to 5 (excruciating pain).
1 secondary outcome
The degree of functional limitation and edema in the marginal mucosa were measured using a Likert scale.
Time frame: 4 DAYS
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GV-328 in people with Aphthous Stomatitis, run by Universitat Internacional de Catalunya at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The level of pain was measured on the Wong-Baker Faces Scale (WBFS) (time frame: 4 DAYS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2021.