A phase II study to assess the efficacy, safety and pharmacokinetics of M529101 for pain in oral mucositis derived from head and neck cancer treatment.

A phase II, randomaized,double-blind, placebo-controlled, dose-escalation, parallel-group, multicenter study to assess the efficacy, safety amd pharmacokinetics of M529101 for pain in oral mucositis derived from head and neck cancer treatment

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031220421

Enrollment

Registered

2022-10-28

Start date

2023-01-24

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

Pain in oral mucositis derived from head and neck cancer treatment

Interventions

M529101 or M529101placebo will be swallowed after keeping it in the oral cavity

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients aged 18 years or older with malignant tumor of head and neck (Male and female who are determined to be infertile) 2. Patients planning or undergoing chemoradiotherapy with cisplatin or radiotherapy 3. Patients with an Eastern Cooperative Oncology Group performance status score of 0 or 1

Exclusion criteria

Exclusion criteria: 1. Patients complicated with diseases considered inappropriate for participation in clinical trials such as serious cardiac / hepatic /renal / pulmonary / hematologic disease 2. Patients who are judged to be abnormal by the principal investigator or sub-investigator based on vital signs and electrocardiogram that are considered inappropriate for participation

Design outcomes

Primary

Measure	Time frame
Numerical rating scale for pain	—

Contacts

Public Contact- Clinical Trials Information

Maruho Co.,Ltd. Kyoto R&D Center

ctinfo@mii.maruho.co.jp+81-75-325-3279

Outcome results

None listed

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