NCT03546985

Brief 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 data in the product registration in China.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 26, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 23, 2018

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 8, 2018

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 25, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 6, 2018

Completed
Last Updated

June 8, 2018

Status Verified

June 1, 2018

Enrollment Period

4 months

First QC Date

April 23, 2018

Last Update Submit

June 7, 2018

Conditions

Chemotherapy- and/or Radiation-induced Oral Mucositis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Pain intensity decrease inside the oral cavity

    During 6 hours after a single use of investigational medical device

  • Peak pain intensity difference inside the oral cavity

    During 6 hours after a single use of investigational medical device

  • Incidence of adverse events

    2 days

Study Arms (2)

Group A

EXPERIMENTAL
Device: episil®

Group B

ACTIVE COMPARATOR
Device: Kang Su

Interventions

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.

Group A
Kang SuDEVICE

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.

Also known as: Generic of MuGard®
Group B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

The People's Liberation Army 307 Hospital

Beijing, Beijing Municipality, China

Location

Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Location

Tongji Hospital

Wuhan, Hubei, China

Location

Jiangsu Province Hospital

Nanjing, Jiangsu, China

Location

The People's Liberation Army 81 Hospital

Nanjing, Jiangsu, China

Location

The First Hospital of Jilin University

Changchun, Jilin, China

Location

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Location

Study Officials

  • Xinchen Sun

    Jiangsu People's Hospital

    PRINCIPAL INVESTIGATOR

  • Guoyao Tang

    Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2018

First Posted

June 6, 2018

Study Start

December 26, 2017

Primary Completion

May 8, 2018

Study Completion

May 25, 2018

Last Updated

June 8, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(7)