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

Sponsor
Cairo University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04649697
Collaborator
(none)
39
Enrollment
3
Arms
12
Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Rebamipide
  • Drug: Nanoparticulated Rebamipide
  • Drug: Clobetasol Propionate
 Phase 3

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 Design

Study Type:
Interventional
Anticipated Enrollment :
39 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Evaluation of Topical Rebamipide Versus Topical Clobetasol in Management of Methotrexate-Induced Oral Ulceration in Rheumatoid Arthritis Patients: Randomized-Controlled Clinical Trial
Anticipated Study Start Date :
Dec 1, 2020
Anticipated Primary Completion Date :
Nov 30, 2021
Anticipated Study Completion Date :
Nov 30, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Rebamipide

The enrolled subjects will be treated with Rebamipide in orabase 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 orabase 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 orabase 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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. change in the Clinical improvement of oral ulcers [assessment will be at baseline, 2 weeks and 4 weeks]

      Will be assessed using World Health Organization (WHO) grading of mucositis

    Secondary Outcome Measures

    1. Subjective degree of pain [Pain assessment will be daily for the first week then at 2 weeks and 4 weeks.]

      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.

    2. size of oral ulcer [assessment at 0, 2 weeks and 4 weeks]

      The ulcer size was determined by measuring the distance between two opposite edges of the ulcer border, using a periodontal probe in millimeters.

    3. healing time of the ulcer [assessment at 0, 2 weeks and 4 weeks]

      The total healing time of oral ulcers Will be recorded in days for all the patients.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Cairo University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Amira Mohamed Abd el-Aziz Mohamed, Resident, Cairo University
    ClinicalTrials.gov Identifier:
    NCT04649697
    Other Study ID Numbers:
    • CEBC-CU-2020-9
    First Posted:
    Dec 2, 2020
    Last Update Posted:
    Dec 2, 2020
    Last Verified:
    Nov 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Arthritis
    Arthritis, Rheumatoid
    Clobetasol
    Rebamipide

    Study Results

    No Results Posted as of Dec 2, 2020