Comparing Rebamipide and Clobetasol for Oral Ulcers in Rheumatoid Arthritis
Evaluation of Topical Rebamipide Versus Topical Clobetasol in Management of Methotrexate-Induced Oral Ulceration in Rheumatoid Arthritis Patients: Randomized-Controlled Clinical Trial
This study is testing if a new mouth treatment called Rebamipide works better than Clobetasol for helping people with rheumatoid arthritis who have painful mouth ulcers from their medication.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 39 (estimated) |
| Ages | 20 Years to 70 Years |
| Sex | All |
| Sponsor | Cairo University Academic / other |
| Drugs / interventions | Methotrexate |
| Locations | 1 site (Cairo) |
| Trial ID | NCT04649697 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of topical Rebamipide, both in its regular and nanoparticulated forms, against Clobetasol propionate for treating oral mucositis induced by Methotrexate in patients with rheumatoid arthritis. Patients diagnosed with rheumatoid arthritis and experiencing oral ulceration due to Methotrexate will be enrolled from the Rheumatology clinic at Cairo University Hospital. The study will involve a randomized controlled trial design to assess the treatment outcomes and potential benefits of Rebamipide in this specific patient population.
Who should consider this trial
Good fit: Ideal candidates for this study are rheumatoid arthritis patients aged 20-70 who are currently being treated with Methotrexate and suffering from oral ulceration.
Not a fit: Patients who are pregnant, have hypersensitivity to the study drugs, or have other systemic diseases that could complicate treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new effective treatment option for managing oral ulcers in rheumatoid arthritis patients undergoing Methotrexate therapy.
How similar studies have performed: This study represents a novel approach as it is the first to evaluate the use of Rebamipide for Methotrexate-induced oral mucositis in rheumatoid arthritis patients.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Cairo
- Cairo University — Cairo, Egypt (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.