Oral MucositisNCT06276270
Multi-centre, Open-label, First-in-man Study With Mucopad HA
A study testing Mucopad HA in people with Oral Mucositis, run by Contipro Pharma a.s. at 5 sites in Czechia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Mucositis
- What is being tested?
- Mucopad HA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 5 sitesCzechia
- Study dates
- 12 Dec 2023to 30 Nov 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Czechia5 sites
Masarykův onkologický ústav, Klinika radiační onkologie
Brno, Česká Republika, 56401
FN Hradec Králové Klinika onkologie a radioterapie
Hradec Králové, Česká Republika, 56401
Fakultní nemocnice Ostrava, Klinika onkologická
Ostrava, Česká Republika, 56401
Etická komise FN Bulovka
Prague, Česká Republika, 56401
Fakultní Thomayerova nemocnice Onkologická klinika 1.LF UK a FTN
Prague, Česká Republika, 56401
About this study
Official title: 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.
Read the 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.
- Conditions
- Oral Mucositis
- Being tested
- Mucopad HA
- Medical subject headings
- Stomatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mucopad HADevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Device is administered directly onto the area affected by mucositis. | Experimental | Not described Receives: Device: Mucopad HA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resolution of mucositis symptoms since completion of radiotherapy
healing time
Measured: 10 weeks
Secondary outcomes (3)
- Pain management (VAS scale)
pain value 1-100
Measured: 10 weeks
Development of xerostomy
xerostomy yes/no
Measured: 10 weeks
Subjective evaluation on scale 1-5 of the treatment by investigator/ patient
scale 1-5
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2024
- Study start12 Dec 2023
- Primary completion30 Nov 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral MucositisStudies 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Contipro Pharma a.s.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06276270
- Sponsor's protocol ID
- PT-MUC-1_05-21
- Status last verified
- Mar 2026
- First submitted
- 14 Feb 2024
- Last updated
- 20 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-centre, Open-label, First-in-man Study With Mucopad HA Used in Adult Patients Suffered From Oral Mucositis After Radiotherapy
- ClinicalTrials.gov ID
- NCT06276270
- Acronym / sponsor ID
- PT-MUC-1_05-21
- Conditions
- Oral Mucositis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Contipro Pharma a.s.University, hospital or other
- Study start
- 12 Dec 2023 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 23 Feb 2024 (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 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Device is administered directly onto the area affected by mucositis. | Experimental | Device: Mucopad HA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Mucopad HAThe 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. | Device | Device is administered directly onto the area affected by mucositis. |
Primary outcome
Resolution of mucositis symptoms since completion of radiotherapy
Time frame: 10 weeks
healing time
3 secondary outcomes
- Pain management (VAS scale)
Time frame: 10 weeks
Development of xerostomy
Time frame: 10 weeks
Subjective evaluation on scale 1-5 of the treatment by investigator/ patient
Time frame: 10 weeks
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 20 Mar 2026.
- Individual participant dataSharing planned: No
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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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mucopad HA in people with Oral Mucositis, run by Contipro Pharma a.s. at 5 sites in Czechia.
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 4 inclusion and 5 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 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Czechia. 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?
Resolution of mucositis symptoms since completion of radiotherapy (time frame: 10 weeks). 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 20 Mar 2026.