Who is sponsoring NCT03546985?

NCT03546985 is sponsored by Solasia Pharma K.K..

What drugs are being tested in NCT03546985?

Interventions in NCT03546985: episil®, Kang Su.

What condition does NCT03546985 study?

NCT03546985 studies Chemotherapy- and/or Radiation-induced Oral Mucositis.

Is NCT03546985 still recruiting?

NCT03546985 is currently completed. Last updated 8 June 2018.

Last reviewed 2018-06-08 · How we verify

NCT03546985

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Trial of Episil® Oral Liquid in Cancer Patients Suffering From Chemotherapy- and/or Radiation-induced Oral Mucositis

Completed NA Last updated 8 June 2018

What this trial tests

NA trial testing episil® in Chemotherapy- and/or Radiation-induced Oral Mucositis in 60 participants. Completed in 25 May 2018.

Timeline

26 December 2017

Primary endpoint
8 May 2018

25 May 2018

Quick facts

Lead sponsor	Solasia Pharma K.K.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	60
Start date	26 December 2017
Primary completion	8 May 2018
Estimated completion	25 May 2018
Sites	7 locations across China

Drugs / interventions tested

episil®
Kang Su

Conditions studied

Chemotherapy- and/or Radiation-induced Oral Mucositis — all drugs for Chemotherapy- and/or Radiation-induced Oral Mucositis →

Sponsor

Solasia Pharma K.K. — full company profile →

Who can join

18 and older, any sex, with Chemotherapy- and/or Radiation-induced Oral Mucositis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Local analgesic effect of a bioadhesive barrier-forming oral liquid in cancer patients with oral mucositis caused by chemotherapy and/or radiotherapy: a randomized multicenter, single-use, positive-controlled, open-label study.
Cheng Y, Qin SK, Chen YP, Dong LH, et al · · 2018 · cited 14× · PMID 30584316 · DOI 10.2147/ott.s185915
Ionizing radiation: molecular mechanisms, biological effects, and therapeutic targets.
Wei W, Ren Y, Lan J, Yi J, et al · · 2026 · PMID 41507636 · DOI 10.1186/s43556-025-00358-4

Verify or expand the search:

Other Solasia Pharma K.K. trials

Trials by the same sponsor.

NCT05075876 — Bioequivalence Study in Healthy Chinese Subjects Comparing SP-01 (Granisetron Patch) Manufactured at Two Different Sites · Phase 1 · completed
NCT02653976 — A Phase 2 Study of SP-02L in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL) · Phase 2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03546985 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Solasia Pharma K.K.
Last refreshed: 8 June 2018

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03546985.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing