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

Not Applicable

• Conditions: Healthy Adults

• Registration Number: JPRN-jRCTs031220121
• Lead Sponsor: Hida Noriko

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-06-09
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Male
• Target Recruitment: 6

Inclusion 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.

Exclusion 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified