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

Evaluation of Topical Rebamipide Versus Topical Clobetasol in Management of Methotrexate-Induced Oral Ulceration in Rheumatoid Arthritis Patients: Randomized-Controlled Clinical Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Drug: Rebamipide; Drug: Nanoparticulated Rebamipide; Drug: Clobetasol Propionate

Detailed Description

A random sample of patients diagnosed with rheumatoid arthritis attending at the Rheumatology clinic in faculty of Medicine, Cairo University Hospital, will be enrolled by the investigator in the study in a consecutive order after being examined for methotrexate induced oral ulceration by means of history and clinical examination.

Since oral mucositis associated with Methotrexate include production of free radicals, increase of inflammatory cytokines, and alteration of intracellular signal transduction, this suggests that Rebamipide should be useful for its treatment and prevention. Thus, this RCT will be the first to evaluate the treatment of Methotrexate-induced oral mucositis using Rebamipide and Rebamipide nanoparticles in patients with rheumatoid arthritis.

• Study Type: Interventional
• Enrollment (Estimated): 39
• Phase: Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Cairo University
    • Contact: faculty of dentistry; Phone Number: 02 23642705; Email: dentmail@dentistry.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patient who agreed to sign the informed consent.
• Age: 20-70 years old.
• Gender: males and females
• RA patients treated with MTX and suffering from MTX-induced oral ulceration.

Exclusion Criteria:

• Patients refused to sign the informed consent.
• Pregnant or lactating females in their child bearing age group.
• patients with known or suspected history of hypersensitivity to any of the ingredients of the preparation of the drugs used.
• Systemic disease: such as uncontrolled diabetes mellitus, auto-immune diseases known to cause oral ulceration, renal or liver dysfunction or any other condition considered risky by the clinician.
• Patients treated with any medication for the condition at the time of setting.
• Salivary gland diseases.
• Malignancy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rebamipide; The enrolled subjects will be treated with Rebamipide in mucoadhesive gel for 2 weeks or until complete healing.	Drug: Rebamipide; A mucosal protection drug developed in Japan for the treatment of gastritis and gastric ulcer.; Other Names: Mucosta
Experimental: Nanoparticulated Rebamipide; The enrolled subjects will be treated with nanoparticulated Rebamipide in mucoadhesive gel for 2 weeks or until complete healing.	Drug: Nanoparticulated Rebamipide; A mucosal protection drug developed in Japan for the treatment of gastritis and gastric ulcer will be used in nanotechnology.; Other Names: Mucosta
Active Comparator: Clobetasol; The enrolled subjects will be treated with Clobetasol in mucoadhesive gel for 2 weeks or until complete healing.	Drug: Clobetasol Propionate; A corticosteroid drug used as a gold standard for treatment of methotrexate induced oral ulceration.; Other Names: corticosteroids

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in the Clinical improvement of oral ulcers	Will be assessed using World Health Organization (WHO) grading of mucositis	assessment will be at baseline, 2 weeks and 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective degree of pain	All patients were introduced to the Numerical Rating Scale (NRS) and learnt how to express their pain through it, patients were instructed to fill the scale paper at the first visit [baseline], this procedure was repeated for each follow-up visit.	Pain assessment will be daily for the first week then at 2 weeks and 4 weeks.
size of oral ulcer	The ulcer size was determined by measuring the distance between two opposite edges of the ulcer border, using a periodontal probe in millimeters.	assessment at 0, 2 weeks and 4 weeks
healing time of the ulcer	The total healing time of oral ulcers Will be recorded in days for all the patients.	assessment at 0, 2 weeks and 4 weeks

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Estimated): December 30, 2023
• Study Completion (Estimated): December 30, 2023

Study Registration Dates

• First Submitted: October 26, 2020
• First Submitted That Met QC Criteria: November 29, 2020
• First Posted (Actual): December 2, 2020

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 16, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Anti-Inflammatory Agents; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Protective Agents; Anti-Ulcer Agents; Antioxidants; Clobetasol; Rebamipide
• Other Study ID Numbers: CEBC-CU-2020-9

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No