Indomethacin oral spray for the analgesic effect of pain reduction in patient with oral mucositis due to cancer therapy: Randomized, double-blind, placebo-controlled phase II trial

Indomethacin oral spray for the analgesic effect of pain reduction in patient with oral mucositis due to cancer therapy: Randomized, double-blind, placebo-controlled phase II trial - Indomethacin oral spray for the analgesic effect of pain reduction in patient with oral mucositis due to cancer therapy: Randomized, double-blind, placebo-controlled phase II trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000017664

Enrollment

Registered

2015-05-25

Start date

2015-07-01

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

Patients with oral mucisitis due to cancer therapy

Interventions

IOS(0.8mg)is orally adminstered by spray after lunch.4hours later, IOS is administered before each meal and when pain appears.Treatment ends after 24hours from the initiation. Placebo(0.8mg)is orally

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Able to give written informed consent 2)Patients aged 20 or above at the time of obtaining informed consent 3)Histologically confirmed diagnosis of cancer 4)Hospitalized patients with oral mucositis due to chemotherapy and/or radiotherapy 5)Patients with oral mucositis CTCAE(Ver. 4) Grade <=3 and received oral care 6)Patients with oral mucositis pain(BPI item5) >=4 7)Patients with expected survival of 1month or longer 8)Patients who can take oral drugs

Exclusion criteria

Exclusion criteria: 1)Patients who have experience of IOS 2)Patients who have other important disorder that needs to be prioritized the treatment 3)Allergy due to NSAIDS 4)Patients who are judged to be inappropriate by the physician

Design outcomes

Primary

Measure	Time frame
Brief Pain Inventry(BPI)- item6 change between before(0min) and after IOS treatment(30min).	—

Secondary

Measure	Time frame
1)Area Under the Curve of BPI-item6 after IOS teatment(0min,15min,60min,120min,180min and 240min) 2)BPI (item3,4,5,6,8) cange between before(0min) and after IOS treatment(24hours) 3)Global impression 4)Minimal clinically important difference 5)Adverse effect	—

Countries

Japan

Contacts

Public ContactHiroka Nagaoka

Universiyy of Tsukuba Hospital General Medicine and Primary Care, Team for Palliative Care

nagaoka3taro@gmail.com029-853-3900

Outcome results

None listed

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