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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Oral Mucositis
• Intervention / Treatment: Device: Mucopad HA

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pavel Kušnierik; Phone Number: +420775418823; Email: pavel.kusnierik@contipro.com
• Study Contact Backup: Name: Kateřina H Hynková Tichá; Phone Number: +420770199169; Email: katerina.ticha@contipro.com

Study Locations

• Czechia
  • Česká Republika
    • Brno, Česká Republika, Czechia, 56401
      • Recruiting
      • Masarykův onkologický ústav, Klinika radiační onkologie
      • Contact: Tomáš Novotný; Phone Number: +420543131103; Email: novotny@mou.cz
    • Hradec Králové, Česká Republika, Czechia, 56401
      • Recruiting
      • FN Hradec Králové Klinika onkologie a radioterapie
      • Contact: Milan Vošmik; Phone Number: +420495832316; Email: milan.vosmik@fnhk.cz
    • Ostrava, Česká Republika, Czechia, 56401
      • Recruiting
      • Fakultní nemocnice Ostrava, Klinika onkologická
      • Contact: Jana Jackaninová; Phone Number: +420597371111; Email: jana.jackaninova@fno.cz
    • Praha, Česká Republika, Czechia, 56401
      • Recruiting
      • Etická komise FN Bulovka
      • Contact: Petra Holečková; Phone Number: +420266084516; Email: petra.holeckova@bulovka.cz
    • Praha, Česká Republika, Czechia, 56401
      • Recruiting
      • Fakultní Thomayerova nemocnice Onkologická klinika 1.LF UK a FTN
      • Contact: Radka Lohynská; Phone Number: +420261083890; Email: radka.lohynska@ftn.cz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Device is administered directly onto the area affected by mucositis.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resolution of mucositis symptoms since completion of radiotherapy	healing time	10 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
- Pain management (VAS scale)	pain value 1-100	10 weeks
Development of xerostomy	xerostomy yes/no	10 weeks
Subjective evaluation on scale 1-5 of the treatment by investigator/ patient	scale 1-5	10 weeks

Collaborators and Investigators

• Sponsor: Contipro Pharma a.s.

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: February 14, 2024
• First Submitted That Met QC Criteria: February 21, 2024
• First Posted (Actual): February 23, 2024

Study Record Updates

• Last Update Posted (Actual): February 23, 2024
• Last Update Submitted That Met QC Criteria: February 21, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Stomatognathic Diseases; Mouth Diseases; Mucositis; Stomatitis
• Other Study ID Numbers: PT-MUC-1_05-21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No