Safety evaluation of indomethacin-containing oral mucosa adaptive formulation for pain relief of oral mucositis in cancer patients

JRCT ID: jRCTs031220121

Registered date:09/06/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Healthy Adults
• Date of first enrollment: 21/07/2022
• Target sample size: 6
• Study type: Interventional
• Intervention(s): In this study, the administration of indomethacin (oral spray, etc.) to healthy adults constitutes a medical practice that is beyond the scope of normal medical care as research, and thus constitutes an intervention.

Outcome(s)

• Primary Outcome: Irritation to the oral mucosa (presence of inflammation)

Secondary Outcome

Urinary indomethacin and metabolite concentrations from 0 to 8 hours
Sensory evaluation and residual status by subjects and test physicians (immediately after use and 1 hour after use)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 65age old
• Gender: Male

Include criteria

(1) Age: 20 years old or older and less than 65 years old at the time of obtaining consent.
(2) Gender: Male
(3) BMI: 18 to 35
(4) Who have the capacity to consent and can abide by the compliance requirements during participation in the study.
(5) Persons who have been judged by the principal investigator or subinvestigator to be eligible to participate in this study during the preliminary examination as stipulated in the protocol for this study.

Exclude criteria

(1) Persons with a medical history (drug abuse/dependence, alcohol abuse/dependence, heart, liver, kidney, lung, eye, or blood disease, etc.) that may affect the evaluation and safety of this study.
(2) Those with obvious ulcers or trauma to the oral cavity.
(3) Currently undergoing dental treatment
(4) History of drug allergy or allergy to indomethacin
(5) Those with a history or current history of aspirin asthma
(6) Are taking any medications (including dietary supplements and dietary supplements) that may affect the evaluation and safety of this study.
(7) Persons who are using or may use all medications (including OTC) containing indomethacin.
(8) Current smokers who are unable to quit during the study period.
(9) Persons who regularly use excessive amounts of alcohol (those who cannot maintain abstinence from alcohol on the day before and the day of the study drug for the duration of the study).
(10) Those who are within three months of participating in another clinical research study.
(11) Any other person who is judged by the principal investigator or a subinvestigator to be ineligible for this study.

Related Information

• Primary Sponsor: Hida Noriko
• Secondary Sponsor: Momo Kenji
• Source(s) of Monetary Support: Falnex Inc.,