Evaluation of Topical Rebamipide Versus Topical Clobetasol in Management of Methotrexate-Induced Oral Ulceration in Rheumatoid Arthritis Patients: Randomized-Controlled Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- change in the Clinical improvement of oral ulcers
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Rebamipide
The enrolled subjects will be treated with Rebamipide in mucoadhesive gel for 2 weeks or until complete healing.
干预措施: Rebamipide (Drug)
Nanoparticulated Rebamipide
The enrolled subjects will be treated with nanoparticulated Rebamipide in mucoadhesive gel for 2 weeks or until complete healing.
干预措施: Nanoparticulated Rebamipide (Drug)
Clobetasol
The enrolled subjects will be treated with Clobetasol in mucoadhesive gel for 2 weeks or until complete healing.
干预措施: Clobetasol Propionate (Drug)
结局指标
主要结局
change in the Clinical improvement of oral ulcers
时间窗: assessment will be at baseline, 2 weeks and 4 weeks
Will be assessed using World Health Organization (WHO) grading of mucositis
次要结局
- healing time of the ulcer(assessment at 0, 2 weeks and 4 weeks)
- Subjective degree of pain(Pain assessment will be daily for the first week then at 2 weeks and 4 weeks.)
- size of oral ulcer(assessment at 0, 2 weeks and 4 weeks)
研究者
Amira Mohamed Abd el-Aziz Mohamed
Resident
Cairo University