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.

JRCT ID: jRCT2031220421

Registered date:28/10/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Pain in oral mucositis derived from head and neck cancer treatment
• Date of first enrollment: 24/01/2023
• Target sample size: 18
• Study type: Interventional
• Intervention(s): M529101 or M529101placebo will be swallowed after keeping it in the oral cavity

Outcome(s)

• Primary Outcome: Numerical rating scale for pain

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Tomoyuki Nishiura