Rheumatoid ArthritisPhase 3NCT04649697
Rebamipide (Regular & Nanoparticulated) vs. Clobetasol in Management of Methotrexate-Induced Oral Ulceration in Rheumatoid Arthritis Patients
A Phase 3 study testing Rebamipide, Nanoparticulated Rebamipide and Clobetasol Propionate in people with Rheumatoid Arthritis, run by Cairo University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Rebamipide, Nanoparticulated Rebamipide and Clobetasol Propionate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2020to 30 Dec 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University
Cairo
faculty of dentistry, 02 23642705, dentmail@dentistry.cu.edu.eg
About this study
Official title: Evaluation of Topical Rebamipide Versus Topical Clobetasol in Management of Methotrexate-Induced Oral Ulceration in Rheumatoid Arthritis Patients: Randomized-Controlled Clinical Trial
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.
Read the 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.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Rebamipide, Nanoparticulated Rebamipide, Clobetasol Propionate
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RebamipideDrug
Also called Mucosta
A mucosal protection drug developed in Japan for the treatment of gastritis and gastric ulcer.
Nanoparticulated RebamipideDrug
Also called Mucosta
A mucosal protection drug developed in Japan for the treatment of gastritis and gastric ulcer will be used in nanotechnology.
Clobetasol PropionateDrug
Also called corticosteroids
A corticosteroid drug used as a gold standard for treatment of methotrexate induced oral ulceration.
| Study group | Role | What they receive |
|---|---|---|
| Rebamipide | Experimental | The enrolled subjects will be treated with Rebamipide in mucoadhesive gel for 2 weeks or until complete healing. Receives: Drug: Rebamipide |
| Nanoparticulated Rebamipide | Experimental | The enrolled subjects will be treated with nanoparticulated Rebamipide in mucoadhesive gel for 2 weeks or until complete healing. Receives: Drug: Nanoparticulated Rebamipide |
| Clobetasol | Active comparator | The enrolled subjects will be treated with Clobetasol in mucoadhesive gel for 2 weeks or until complete healing. Receives: Drug: Clobetasol Propionate |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in the Clinical improvement of oral ulcers
Will be assessed using World Health Organization (WHO) grading of mucositis
Measured: assessment will be at baseline, 2 weeks and 4 weeks
Secondary outcomes (3)
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.
Measured: Pain assessment will be daily for the first week then at 2 weeks and 4 weeks.
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.
Measured: assessment at 0, 2 weeks and 4 weeks
healing time of the ulcer
The total healing time of oral ulcers Will be recorded in days for all the patients.
Measured: assessment at 0, 2 weeks and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2020
- Study start1 Dec 2020
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Mohamed Abd el-Aziz Mohamed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04649697
- Sponsor's protocol ID
- CEBC-CU-2020-9
- Status last verified
- Sep 2023
- First submitted
- 26 Oct 2020
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Topical Rebamipide Versus Topical Clobetasol in Management of Methotrexate-Induced Oral Ulceration in Rheumatoid Arthritis Patients: Randomized-Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04649697
- Acronym / sponsor ID
- CEBC-CU-2020-9
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 2 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Rebamipide | Experimental | Drug: RebamipideThe enrolled subjects will be treated with Rebamipide in mucoadhesive gel for 2 weeks or until complete healing. |
| Nanoparticulated Rebamipide | Experimental | Drug: Nanoparticulated RebamipideThe enrolled subjects will be treated with nanoparticulated Rebamipide in mucoadhesive gel for 2 weeks or until complete healing. |
| Clobetasol | Active comparator | Drug: Clobetasol PropionateThe enrolled subjects will be treated with Clobetasol in mucoadhesive gel for 2 weeks or until complete healing. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RebamipideAlso: MucostaA mucosal protection drug developed in Japan for the treatment of gastritis and gastric ulcer. | Drug | Rebamipide |
| Nanoparticulated RebamipideAlso: MucostaA mucosal protection drug developed in Japan for the treatment of gastritis and gastric ulcer will be used in nanotechnology. | Drug | Nanoparticulated Rebamipide |
| Clobetasol PropionateAlso: corticosteroidsA corticosteroid drug used as a gold standard for treatment of methotrexate induced oral ulceration. | Drug | Clobetasol |
Primary outcome
change in the Clinical improvement of oral ulcers
Time frame: assessment will be at baseline, 2 weeks and 4 weeks
Will be assessed using World Health Organization (WHO) grading of mucositis
3 secondary outcomes
Subjective degree of pain
Time frame: Pain assessment will be daily for the first week then at 2 weeks and 4 weeks.
size of oral ulcer
Time frame: assessment at 0, 2 weeks and 4 weeks
healing time of the ulcer
Time frame: assessment at 0, 2 weeks and 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rebamipide, Nanoparticulated Rebamipide and Clobetasol Propionate in people with Rheumatoid Arthritis, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in the Clinical improvement of oral ulcers (time frame: assessment will be at baseline, 2 weeks and 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.