Clinical trial · Interventional
A Trial of Episil® Oral Liquid in Cancer Patients Suffering From Chemotherapy- and/or Radiation-induced Oral Mucositis
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemotherapy- and/or Radiation-induced Oral Mucositis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| episil® | Device | — | UNRESOLVED |
| Kang Su | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group A
- interventionNames
- Device: episil®
- type
- ACTIVE_COMPARATOR
- label
- Group B
- interventionNames
- Device: Kang Su
Primary outcomes (1)
- measure
- Area under the curve (AUC) of pain score of oral mucositis
- timeFrame
- During 6 hours after a single use of investigational medical device
- description
- Oral mucosal pain is assessed by a numerical score (0-10 Likert-pain scale).
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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.
References
Publications (0)
Data not yet available