CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 13 enrolled
Drug / intervention
0.25% EISO mouth rinsedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02399228
NCT02399228Phase 2Completed
CompareCT.gov

An Open-Label, Proof of Concept, Efficacy, Safety and Tolerability Trial of a Botanical Drug Containing East Indian Sandalwood Oil (EISO) for the Prevention and Treatment of Oral Mucositis Induced by Radiation Therapy

Santalis Pharmaceuticals, Inc.·interventional·Posted Mar 26, 2015·Updated Nov 19, 2021

In Brief

A Phase 2 clinical trial evaluating 0.25% EISO mouth rinse for Oral Mucositis. Completed, enrolled 13 participants across 1 site.

Detailed Summary

The initial proposed clinical study will be conducted in adult head and neck cancer subjects. This will be an open-labeled, proof of concept trial to evaluate the efficacy, safety and tolerability of EISO in a form of oral rinse as adjunctive therapy to standard of care. Santalis believes that the proposed study is a prudent and appropriate approach to investigate the potential of their product to prevent or improve oral mucositis symptoms commonly seen in subjects undergoing radiotherapy with or without chemotherapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOral Mucositis
CountriesUnited States
CollaboratorsThe University of Texas Health Science Center at San Antonio

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedMar 26, 2015
Enrollment StartOct 4, 2015
Primary CompletionMay 20, 2017
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 11.3 years ago

Interventions

0.25% EISO mouth rinsedrug

A mouth rinse to be used three times a day during the course of radiation and/or chemotherapy to prevent or minimize oral mucositis