Effects of the indomethacin spray in patient with radiation-induced oral mucositis (Rondomised,double blind, placebo controlled crossover study)

Effects of the indomethacin spray in patient with radiation-induced oral mucositis (Rondomised,double blind, placebo controlled crossover study) - Effects of the indomethacin spray in patient with radiation-induced oral mucositis

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000015020

Enrollment

Registered

2014-09-30

Start date

2014-10-01

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

Head and neck cancer patients with radiation induced oral mucositis

Interventions

administration of indomethacin spray administration of placebo

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)The patient of oropharyngeal cancer or maxillary or oral cancer. 2)The patient with oral mucositis (>Gr.1 NCI CTCAE Ver.3) and pain (>VAS50mm) 3)Indomethacin spray is available 4)Perfomance status(ECOG) 0 or 1. 5)Over 20 age (at the time of the agreement acquisition).

Exclusion criteria

Exclusion criteria: 1)Patient with serious comorbidities. 2)Patient with Gr.2 or more mucositis but no pain. 3)During(or Planning of) the study of a clinical experimental medicine. 4)Contraindication of NSAIDs 5)Patient whom the chief physician or principal investigator judged to be inappropriate.

Design outcomes

Primary

Measure	Time frame
analgesic effect of the indomethacin spray for radiation induced oral mucositis (VAS after 30 minutes)	—

Secondary

Measure	Time frame
Safty of indomethacin spray for radiation induced oral mucositis	—

Countries

Japan

Contacts

Public ContactHironobu Hata

Department of oral pathobiological Science, Graduate school of dental medicine , Hokkaido University Oral diagnosis and medicine

hata@den.hokudai.ac.jp0117064280

Outcome results

None listed

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