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

Primary Purpose

Rheumatoid Arthritis

Status
Recruiting
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Rebamipide
Nanoparticulated Rebamipide
Clobetasol Propionate
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Cairo UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Rebamipide

Nanoparticulated Rebamipide

Clobetasol

Arm Description

The enrolled subjects will be treated with Rebamipide in mucoadhesive gel for 2 weeks or until complete healing.

The enrolled subjects will be treated with nanoparticulated Rebamipide in mucoadhesive gel for 2 weeks or until complete healing.

The enrolled subjects will be treated with Clobetasol in mucoadhesive gel for 2 weeks or until complete healing.

Outcomes

Primary Outcome Measures

change in the Clinical improvement of oral ulcers
Will be assessed using World Health Organization (WHO) grading of mucositis

Secondary Outcome Measures

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

Full Information

First Posted
October 26, 2020
Last Updated
September 16, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT04649697
Brief Title
Rebamipide (Regular & Nanoparticulated) vs. Clobetasol in Management of Methotrexate-Induced Oral Ulceration in Rheumatoid Arthritis Patients
Official Title
Evaluation of Topical Rebamipide Versus Topical Clobetasol in Management of Methotrexate-Induced Oral Ulceration in Rheumatoid Arthritis Patients: Randomized-Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
39 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Rebamipide
Arm Type
Experimental
Arm Description
The enrolled subjects will be treated with Rebamipide in mucoadhesive gel for 2 weeks or until complete healing.
Arm Title
Nanoparticulated Rebamipide
Arm Type
Experimental
Arm Description
The enrolled subjects will be treated with nanoparticulated Rebamipide in mucoadhesive gel for 2 weeks or until complete healing.
Arm Title
Clobetasol
Arm Type
Active Comparator
Arm Description
The enrolled subjects will be treated with Clobetasol in mucoadhesive gel for 2 weeks or until complete healing.
Intervention Type
Drug
Intervention Name(s)
Rebamipide
Other Intervention Name(s)
Mucosta
Intervention Description
A mucosal protection drug developed in Japan for the treatment of gastritis and gastric ulcer.
Intervention Type
Drug
Intervention Name(s)
Nanoparticulated Rebamipide
Other Intervention Name(s)
Mucosta
Intervention Description
A mucosal protection drug developed in Japan for the treatment of gastritis and gastric ulcer will be used in nanotechnology.
Intervention Type
Drug
Intervention Name(s)
Clobetasol Propionate
Other Intervention Name(s)
corticosteroids
Intervention Description
A corticosteroid drug used as a gold standard for treatment of methotrexate induced oral ulceration.
Primary Outcome Measure Information:
Title
change in the Clinical improvement of oral ulcers
Description
Will be assessed using World Health Organization (WHO) grading of mucositis
Time Frame
assessment will be at baseline, 2 weeks and 4 weeks
Secondary Outcome Measure Information:
Title
Subjective degree of pain
Description
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.
Time Frame
Pain assessment will be daily for the first week then at 2 weeks and 4 weeks.
Title
size of oral ulcer
Description
The ulcer size was determined by measuring the distance between two opposite edges of the ulcer border, using a periodontal probe in millimeters.
Time Frame
assessment at 0, 2 weeks and 4 weeks
Title
healing time of the ulcer
Description
The total healing time of oral ulcers Will be recorded in days for all the patients.
Time Frame
assessment at 0, 2 weeks and 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Cairo University
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
faculty of dentistry
Phone
02 23642705
Email
dentmail@dentistry.cu.edu.eg

12. IPD Sharing Statement

Learn more about this trial

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

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