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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04649697
• Other study ID #: CEBC-CU-2020-9
• Status: Recruiting
• Phase: Phase 3
• Start date: December 1, 2020
• Est. completion date: December 30, 2023

Study information

• Verified date: September 2023
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 39
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Rebamipide
A mucosal protection drug developed in Japan for the treatment of gastritis and gastric ulcer.
• Nanoparticulated Rebamipide
A mucosal protection drug developed in Japan for the treatment of gastritis and gastric ulcer will be used in nanotechnology.
• Clobetasol Propionate
A corticosteroid drug used as a gold standard for treatment of methotrexate induced oral ulceration.

Locations

Country	Name	City	State
Egypt	Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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
Secondary	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