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.
Phase 2
Recruiting
- Conditions
- Pain in oral mucositis derived from head and neck cancer treatment
- Registration Number
- JPRN-jRCT2031220421
- Lead Sponsor
- Tomoyuki Nishiura
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 18
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method