Exploratory study of a topically indicated formulation of indomethacin-containing oral mucosa

JRCT ID: jRCTs031230701

Registered date:14/03/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: After the removal of the tonsils
• Date of first enrollment: 14/03/2024
• Target sample size: 10
• Study type: Interventional
• Intervention(s): Oral spray for topical application on oral mucosa containing indomethacin

Outcome(s)

• Primary Outcome: Pain assessment (100 mm VAS) at 30 minutes after study drug administration with at least 25% reduction

Secondary Outcome

Irritation to oral mucosa
Safety
Reduction of pain in the oral mucosa (change over time after 30 minutes of pain assessment (VAS))

Key inclusion & exclusion criteria

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

Include criteria

1) Age: Patients who are at least 18 years old at the time of obtaining consent
2) Patients who underwent palatotonsillectomy the morning before the previous day
3) Patients with pain greater than 40 mm on the pain scale (100 mm VAS) at the time of study entry (immediately prior to study drug administration)
4) Patients who have been taking analgesics or using topical oral steroids for more than one hour immediately prior to the study
5) Patients who have an interval of at least 3 hours between the next analgesic medication administration of a regular postoperative prescription
6) Patients who are expected to be hospitalized during study participation
7) Patients who have the ability to consent and comply with the compliance requirements during participation in the study
8) Patients who are judged by the principal investigator or subinvestigator to be eligible for participation in the study based on the pre-testing specified in the study protocol.

Exclude criteria

1) Patients with e-GFR (/mL/min/1.73m2) less than 30
2) Patients with serious complications (severe pneumonia, heart failure, etc.) that make participation in the study undesirable
3) Patients with peptic ulcers or other contraindications (including triamterene, which is contraindicated) in the INTEBAN SP package insert
4) Patients with a history of drug allergy or allergy to indomethacin
(5) Patients with a history or current history of aspirin asthma
6) Women of childbearing potential or pregnant and lactating women
7) Patients who may require rescue medication (e.g., non-steroidal anti-inflammatory drugs) for oral pain relief from 1 hour before to 3 hours after administration of the study drug
8) Other patients who are deemed ineligible for this study by the principal investigator or a subinvestigator.

Related Information

• Primary Sponsor: Shimane Toshikazu
• Source(s) of Monetary Support: Grants-in-Aid for Scientific Research from Japan Society for the Promotion of Science