Chemotherapy- and/or Radiation-induced Oral Mucositis Clinical Trial
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
| NCT number | NCT03546985 |
| Other study ID # | SP-0301 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | December 26, 2017 |
| Est. completion date | May 25, 2018 |
| Verified date | June 2018 |
| Source | Solasia Pharma K.K. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 60 |
| Est. completion date | May 25, 2018 |
| Est. primary completion date | May 8, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| China | The People's Liberation Army 307 Hospital | Beijing | Beijing |
| China | The First Hospital of Jilin University | Changchun | Jilin |
| China | Jiangsu Province Hospital | Nanjing | Jiangsu |
| China | The People's Liberation Army 81 Hospital | Nanjing | Jiangsu |
| China | Fudan University Shanghai Cancer Center | Shanghai | Shanghai |
| China | Fourth Hospital of Hebei Medical University | Shijiazhuang | Hebei |
| China | Tongji Hospital | Wuhan | Hubei |
| Lead Sponsor | Collaborator |
|---|---|
| Solasia Pharma K.K. | Solasia Medical Information Consulting (Shanghai) Co. Ltd. |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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). | During 6 hours after a single use of investigational medical device | |
| Secondary | Pain intensity decrease inside the oral cavity | Oral mucosal pain is assessed by a numerical score (0-10 Likert-pain scale). | During 6 hours after a single use of investigational medical device | |
| Secondary | Peak pain intensity difference inside the oral cavity | Oral mucosal pain is assessed by a numerical score (0-10 Likert-pain scale). | During 6 hours after a single use of investigational medical device | |
| Secondary | Incidence of adverse events | 2 days |