NCT04649697

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
39

participants targeted

Target at below P25 for phase_3 rheumatoid-arthritis

Timeline
Completed

Started Dec 2020

Typical duration for phase_3 rheumatoid-arthritis

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 26, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 2, 2020

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

September 21, 2023

Status Verified

September 1, 2023

Enrollment Period

3.1 years

First QC Date

October 26, 2020

Last Update Submit

September 16, 2023

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • change in the Clinical improvement of oral ulcers

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

    assessment will be at baseline, 2 weeks and 4 weeks

Secondary Outcomes (3)

  • 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

  • healing time of the ulcer

    assessment at 0, 2 weeks and 4 weeks

Study Arms (3)

Rebamipide

EXPERIMENTAL

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

Drug: Rebamipide

Nanoparticulated Rebamipide

EXPERIMENTAL

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

Drug: Nanoparticulated Rebamipide

Clobetasol

ACTIVE COMPARATOR

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

Drug: Clobetasol Propionate

Interventions

RebamipideDRUG

A mucosal protection drug developed in Japan for the treatment of gastritis and gastric ulcer.

Also known as: Mucosta
Rebamipide
Nanoparticulated RebamipideDRUG

A mucosal protection drug developed in Japan for the treatment of gastritis and gastric ulcer will be used in nanotechnology.

Also known as: Mucosta
Nanoparticulated Rebamipide
Clobetasol PropionateDRUG

A corticosteroid drug used as a gold standard for treatment of methotrexate induced oral ulceration.

Also known as: corticosteroids
Clobetasol

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

rebamipideClobetasolAdrenal Cortex Hormones

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

BetamethasoneSteroids, FluorinatedSteroidsFused-Ring CompoundsPolycyclic CompoundsHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident

Study Record Dates

First Submitted

October 26, 2020

First Posted

December 2, 2020

Study Start

December 1, 2020

Primary Completion

December 30, 2023

Study Completion

December 30, 2023

Last Updated

September 21, 2023

Record last verified: 2023-09

Locations

EG(1)