Multi-centre, Open-label, First-in-man Study With Mucopad HA

Oral Mucositis Clinical Trial

Official title:

Multi-centre, Open-label, First-in-man Study With Mucopad HA Used in Adult Patients Suffered From Oral Mucositis After Radiotherapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06276270
• Other study ID #: PT-MUC-1_05-21
• Status: Recruiting
• Phase: N/A
• Start date: December 12, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: Contipro Pharma a.s.
• Contact: Pavel Kušnierik
• Phone: +420775418823
• Email: pavel.kusnierik[@]contipro.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The device´s intended use is to treat defects and/or lesions of the oral mucosa, e.g. oral mucositis.To prove safety of the device in terms of clinical results.

Description:

This is an multi-centre, open-label, first-in-man prospective study.

Up to 60 patients in total will be involved in the open-label trial of new medical device - Mucopad HA. Eligible patients will be undergoing treatment with the device for up to 10 weeks, after which it is expected that there should be significant improvement in the healing process of oral mucositis after radiotherapy. It is considered as an improvement when there is a significant reduction or complete resolution of the mucositis. Mucositis will be assessed as a WHO scale.

Quality of life will be assessed by Oral Mucositis Daily Questionnaire (OMDQ) provided by FACIT. The FACIT and all related works are owned and copyrighted by, and the intellectual property of David Cella, Ph.D. Permission for use of the OMDQ questionnaire is obtained by contacting Dr. Cella at information@facit.org.

List of investigational sites is in appendix 7.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 years

• Oral Mucositis after radiotherapy of grade I - IV according to WHO

• Patient willing and able to provide the written consent

• Ability to communicate well with the investigator in the local language, and to understand and comply with the requirements of the study

Exclusion Criteria:

• Age < 18 years

• Pregnant or lactating women

• Patients in terminal stage of living

• Patients with known hypersensitivity or allergy to any of the substances contained in Medical Device

• Alcohol or drug abuse

Related Conditions & MeSH terms

• Mucositis
• Oral Mucositis
• Stomatitis

Intervention

Device:
• Mucopad HA
The product is a Class III Medical Device incorporating a medicinal substance (antiseptics-octenidine) within the composition made of sodium hyaluronate polysacharide stabilised by calcium chloride. Device is administered directly onto the area affected by mucositis.

Locations

Country	Name	City	State
Czechia	Masarykuv onkologický ústav, Klinika radiacní onkologie	Brno	Ceská Republika
Czechia	FN Hradec Králové Klinika onkologie a radioterapie	Hradec Králové	Ceská Republika
Czechia	Fakultní nemocnice Ostrava, Klinika onkologická	Ostrava	Ceská Republika
Czechia	Etická komise FN Bulovka	Praha	Ceská Republika
Czechia	Fakultní Thomayerova nemocnice Onkologická klinika 1.LF UK a FTN	Praha	Ceská Republika

Sponsors (1)

Lead Sponsor	Collaborator
Contipro Pharma a.s.

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resolution of mucositis symptoms since completion of radiotherapy	healing time	10 weeks
Secondary	- Pain management (VAS scale)	pain value 1-100	10 weeks
Secondary	Development of xerostomy	xerostomy yes/no	10 weeks
Secondary	Subjective evaluation on scale 1-5 of the treatment by investigator/ patient	scale 1-5	10 weeks