Evaluation of preventive efficacy of Irsogladine maleate to stomatitis by Fluoropyrimidine anticancer agent.

Evaluation of preventive efficacy of Irsogladine maleate to stomatitis by Fluoropyrimidine anticancer agent. - Evaluation of preventive efficacy of Irsogladine maleate to stomatitis by Fluoropyrimidine anticancer agent.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000008810

Enrollment

Registered

2012-08-30

Start date

2012-08-31

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stomatitis by anticancer agent.

Interventions

Irsogladine maleate (GaslonN OD Tablets) No medication

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Patients who use Fluoropyrimidine anticancer agent, and are more than 20 years old. 2)Patients who has symptoms to exacerbate gastric ulcer, acute gastritis and/or chronic gastritis. 3)Informed consent.

Exclusion criteria

Exclusion criteria: 1)Patients with stomatitis and/or oral symptoms before the start of treatment. 2)Patients who are pregnant, suspected to be pregnant or breastfeeding. 3)Patients with drug allergy and/or history of severe side effect due to irsogladine maleate. 4)The patient who was considered ineligible by the investigators.

Design outcomes

Primary

Measure	Time frame
Stomatitis is more than Grade2 of CTCAE. Occurrence of oral symptoms.	—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026