Rebamipide (Regular & Nanoparticulated) vs. Clobetasol in Management of Methotrexate-Induced Oral Ulceration in Rheumatoid Arthritis Patients

NCT04649697 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2023-09-21

No results posted yet for this study

Summary

The aim of this intervention study is to compare the effect of topical Rebamipide (regular and nanoparticulated) to topical Clobetasol propionate in management of Methotrexate induced oral mucositis in patients with rheumatoid arthritis.

Conditions

Interventions

DRUG

Rebamipide

A mucosal protection drug developed in Japan for the treatment of gastritis and gastric ulcer.

DRUG

Nanoparticulated Rebamipide

A mucosal protection drug developed in Japan for the treatment of gastritis and gastric ulcer will be used in nanotechnology.

DRUG

Clobetasol Propionate

A corticosteroid drug used as a gold standard for treatment of methotrexate induced oral ulceration.

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-01
Primary Completion
2023-12-30
Completion
2023-12-30

Countries

  • Egypt

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04649697 on ClinicalTrials.gov