NCT02769494

Brief Summary

This study aims at evaluating efficacy and safety of topical using Mesalazine Sustained-Release Tablets in in the treatment of oral ulcers in patients with Crohn's disease.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2016

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Study Start

First participant enrolled

March 1, 2016

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

March 9, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 11, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

February 1, 2023

Status Verified

January 1, 2023

Enrollment Period

9 months

First QC Date

March 9, 2016

Last Update Submit

January 30, 2023

Conditions

Crohn's DiseaseOral Ulcer

Keywords

Oral ulcerCrohn's disease

Outcome Measures

Primary Outcomes (2)

  • oral ulcer healing

    The primary outcome is ulcer healing, oral ulcer area can be divided into 3 degrees: 1 degrees for a single ulcer, area ≤ 8mm; 2 degree for a single ulcer, 8mm ≤ area ≤ 15mm, or two ulcers, area of every ulcer ≤ 8mm; 3 degree for a single ulcer, area ≥ 15 mm, or 2 ulcers, every area between 8 to 15mm. Recovery refers oral ulcer is healing completely. The effective is the ulcer area decrease more than 1 degree. Invalid means the ulcer area is no change.

    the 7 Days of treatment.

  • oral ulcer recurrence

    to observe the recurrence rate of ulcer

    the 28 Days after the end of treatment.

Secondary Outcomes (2)

  • symptoms effective rates

    At the 7 Days of the treatment, and the 28 Days after the end of treatment.

  • adverse events

    From 1st Day to 7th Days of the treatment and the 28 Days after the end of treatment.

Study Arms (2)

Mesalazine Group

EXPERIMENTAL

Mesalazine Sustained-Release Tablets and 0.02L glycerol mixed, 2.5% mesalazine glycerol suspension liquid, gently apply to the ulcer surface, 3 times/day. Daily treatment time of the drug is 8 am,12 pm and 4 pm.

Drug: Mesalazine Sustained-Release Tablets

Riboflavin Sodium Phosphate Group

ACTIVE COMPARATOR

wipe the riboflavin sodium phosphate injection to the ulcer surface, 3 times/day. Daily treatment time of the drug is am,12 pm and 4 pm.

Drug: Riboflavin Sodium Phosphate Injection

Interventions

Mesalazine Sustained-Release TabletsDRUG

Mesalazine sustained-release tablets 500mg and 0.02L glycerol mixed, the preparation of 2.5% the mesalazine glycerol suspension liquid, gently apply to the ulcer surface, 3 times/day. The application time of the drug is 8:00,12:00, 16:00. Daily 20:00 measure the size of the mouth ulcers and record the symptoms in the diary card.

Also known as: Pentasa
Mesalazine Group
Riboflavin Sodium Phosphate InjectionDRUG

gently apply the riboflavin sodium phosphate injection to the ulcer surface, 3 times/day. The application time of the drug is 8:00,12:00, 16:00. Daily 20:00 measure the size of the mouth ulcers and record the symptoms in the diary card.

Riboflavin Sodium Phosphate Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 18\~65, both gender.
  • Patients with oral ulcer and confirmed Crohn's disease.

You may not qualify if:

  • Contraindications to study drugs.
  • Underwent or will accept oral Surgery.
  • Patients are not able to sign the informed consent or not comply with the study protocol.
  • Planning for pregnancy, pregnancy and lactating women.
  • Enrolled in other clinical trials in the past 30 days.
  • Patients with concurrent / new other serious diseases will affect the effectiveness and safety evaluation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xijing Hospital

Xi'an, Shaanxi, 710032, China

Location

MeSH Terms

Conditions

Crohn DiseaseOral Ulcer

Interventions

MesalamineFlavin Mononucleotide

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

meta-AminobenzoatesAminobenzoatesBenzoatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsAminosalicylic AcidsSalicylatesHydroxybenzoatesHydroxy AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPhenolsRiboflavinFlavinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHeterocyclic Compounds, 3-RingCoenzymesEnzymes and CoenzymesRibonucleotidesNucleotidesNucleic Acids, Nucleotides, and NucleosidesPigments, BiologicalBiological Factors

Study Officials

  • Ying Han, Ph. D

    Degistive Disease of Xijing Hospital, Fourth Military Medical University

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor of Xijing Hospital of Digestive Diseases,Principal

Study Record Dates

First Submitted

March 9, 2016

First Posted

May 11, 2016

Study Start

March 1, 2016

Primary Completion

December 1, 2016

Study Completion

January 1, 2017

Last Updated

February 1, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)