Chemotherapy- and/or Radiation-induced Oral MucositisNCT03546985
A Trial of Episil® Oral Liquid in Cancer Patients Suffering From Chemotherapy- and/or Radiation-induced Oral Mucositis
A study testing episil® and Kang Su in people with Chemotherapy- and/or Radiation-induced Oral Mucositis, run by Solasia Pharma K.K. at 7 sites in China.
Trial summary
This is a randomized, multi-center, single-use, active-controlled, two-stage open study of episil®. The purpose of this study is to assess the local analgesic effect of episil® in cancer patients suffering from chemotherapy- and/or radiation-induced oral mucositis, which will provide scientific and reliable clinical… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapy- and/or Radiation-induced Oral Mucositis
- What is being tested?
- episil® and Kang Su
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 7 sitesChina
- Study dates
- 26 Dec 2017to 25 May 2018
- 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
- Male/female patient 18 years of age;
- Pathological histologic and/or cytological diagnosis of malignant tumor;
- Patients who are suffering from symptomatic oral mucositis (WHO grade 2 or above) during chemotherapy and/or radiotherapy during screening period;
- Patients who are suffering from pain inside the oral cavity caused by oral mucositis, and pain assessment by Likert scale (0-10) results in a score of at least 6 out of 10 during screening period and at enrollment on Day 1;
- Patients undergoing chemotherapy and/or radiotherapy: patients must have received at least one cycle of multiple-cycle chemotherapy regimen and/or have received multiple doses of radiation, prior to the enrollment on Day 1;
- Patients at Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, 2 and 3; and
- Patients are able to provide written informed consent to participate in the study freely after the nature of the study and disclosure of data has been explained to the patients.
Who cannot join
None listed.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites
The People's Liberation Army 307 Hospital
Beijing, Beijing Municipality
The First Hospital of Jilin University
Changchun, Jilin
Jiangsu Province Hospital
Nanjing, Jiangsu
The People's Liberation Army 81 Hospital
Nanjing, Jiangsu
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality
Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei
Tongji Hospital
Wuhan, Hubei
About this study
Official title: A Randomized, Multi-center, Single-use, Active-controlled, Open Study to Assess the Local Analgesic Effect of Episil® Oral Liquid in Cancer Patients Suffering From Chemotherapy- and/or Radiation-induced Oral Mucositis
This is a randomized, multi-center, single-use, active-controlled, two-stage open study of episil®. The purpose of this study is to assess the local analgesic effect of episil® in cancer patients suffering from chemotherapy- and/or radiation-induced oral mucositis, which will provide scientific and reliable clinical data in the product registration in China.
- Being tested
- episil®, Kang Su
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
episil®Device
Firmly press the pump and apply the stream of liquid to the oral cavity 3 times (a total volume of 0.45 mL approximately). Distribute to affected areas in the mouth, for example by using the tongue. Wait for 5 minutes for the protective film to form.
Kang SuDevice
Also called Generic of MuGard®
Gently pour 5 mL of rinse into the mouth, keep the rinse staying in the oral cavity for at least 1 minute, and spilt out the liquid.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Not described Receives: Device: episil® |
| Group B | Active comparator | Not described Receives: Device: Kang Su |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve (AUC) of pain score of oral mucositis
Oral mucosal pain is assessed by a numerical score (0-10 Likert-pain scale).
Measured: During 6 hours after a single use of investigational medical device
Secondary outcomes (3)
Pain intensity decrease inside the oral cavity
Oral mucosal pain is assessed by a numerical score (0-10 Likert-pain scale).
Measured: During 6 hours after a single use of investigational medical device
Peak pain intensity difference inside the oral cavity
Oral mucosal pain is assessed by a numerical score (0-10 Likert-pain scale).
Measured: During 6 hours after a single use of investigational medical device
Incidence of adverse events
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2018
- Study start26 Dec 2017
- Primary completion8 May 2018
- Study completion25 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy- and/or Radiation-induced 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Solasia Pharma K.K.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Solasia Medical Information Consulting (Shanghai) Co. Ltd.
- Responsible party
- Sponsor
- Investigators
- Xinchen Sun, Principal investigator, Jiangsu People's HospitalGuoyao Tang, Principal investigator, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03546985
- Sponsor's protocol ID
- SP-0301
- Status last verified
- Jun 2018
- First submitted
- 23 Apr 2018
- Last updated
- 8 Jun 2018
- 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 8 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multi-center, Single-use, Active-controlled, Open Study to Assess the Local Analgesic Effect of Episil® Oral Liquid in Cancer Patients Suffering From Chemotherapy- and/or Radiation-induced Oral Mucositis
- ClinicalTrials.gov ID
- NCT03546985
- Acronym / sponsor ID
- SP-0301
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Solasia Pharma K.K.Industry (pharma, biotech, devices)
- Collaborators
- Solasia Medical Information Consulting (Shanghai) Co. Ltd.
- Study start
- 26 Dec 2017 (actual)
- Primary completion
- 8 May 2018 (actual)
- Study completion
- 25 May 2018 (actual)
- First posted
- 6 Jun 2018 (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.
This is a randomized, multi-center, single-use, active-controlled, two-stage open study of episil®. The purpose of this study is to assess the local analgesic effect of episil® in cancer patients suffering from chemotherapy- and/or radiation-induced oral mucositis, which will provide scientific and reliable clinical data in the product registration in China.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Device: episil® |
| Group B | Active comparator | Device: Kang Su |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male/female patient 18 years of age;
- Pathological histologic and/or cytological diagnosis of malignant tumor;
- Patients who are suffering from symptomatic oral mucositis (WHO grade 2 or above) during chemotherapy and/or radiotherapy during screening period;
- Patients who are suffering from pain inside the oral cavity caused by oral mucositis, and pain assessment by Likert scale (0-10) results in a score of at least 6 out of 10 during screening period and at enrollment on Day 1;
- Patients undergoing chemotherapy and/or radiotherapy: patients must have received at least one cycle of multiple-cycle chemotherapy regimen and/or have received multiple doses of radiation, prior to the enrollment on Day 1;
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| episil®Firmly press the pump and apply the stream of liquid to the oral cavity 3 times (a total volume of 0.45 mL approximately). Distribute to affected areas in the mouth, for example by using the tongue. Wait for 5 minutes for the protective film to form. | Device | Group A |
| Kang SuAlso: Generic of MuGard®Gently pour 5 mL of rinse into the mouth, keep the rinse staying in the oral cavity for at least 1 minute, and spilt out the liquid. | Device | Group B |
Primary outcome
Area under the curve (AUC) of pain score of oral mucositis
Time frame: During 6 hours after a single use of investigational medical device
Oral mucosal pain is assessed by a numerical score (0-10 Likert-pain scale).
3 secondary outcomes
Pain intensity decrease inside the oral cavity
Time frame: During 6 hours after a single use of investigational medical device
Peak pain intensity difference inside the oral cavity
Time frame: During 6 hours after a single use of investigational medical device
Incidence of adverse events
Time frame: 2 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 8 Jun 2018.
- 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.
Xinchen Sun principal investigator
Jiangsu People's Hospital
Guoyao Tang principal investigator
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing episil® and Kang Su in people with Chemotherapy- and/or Radiation-induced Oral Mucositis, run by Solasia Pharma K.K. at 7 sites in China.
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 7 inclusion and 0 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 8 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in China. 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?
Area under the curve (AUC) of pain score of oral mucositis (time frame: During 6 hours after a single use of investigational medical device). 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 8 Jun 2018.