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The Efficacy of Topical Mesalazine Sustained-Release Tablets in Crohn's Disease Patients With Oral Ulcer

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Xijing Hospital of Digestive Diseases

Status and phase

Withdrawn
Phase 3

Conditions

Oral Ulcer
Crohn's Disease

Treatments

Drug: Mesalazine Sustained-Release Tablets
Drug: Riboflavin Sodium Phosphate Injection

Study type

Interventional

Funder types

Other

Identifiers

NCT02769494
KY20160107-1

Details and patient eligibility

About

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.

Full description

The study will include three phases: screening, treatment and follow-up.

Screening: This phase will last a maximum of 7 days and subjects eligibility will be evaluated after informed consent signature.

Treatment: Subjects are randomly assigned to treatment and will be treated for 7 days. Daily oral ulcer area and symptoms were recorded during the treatment period. A randomization visit will take place on day 0 and an end-of-treatment visit will take place between day 6 and 8.

Follow-up: 28 days after the end of treatment. Efficacy of treatment was evaluated by the oral ulcer remission or decreasing.

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

0 participants in 2 patient groups

Mesalazine Group
Experimental group
Description:
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.
Treatment:
Drug: Mesalazine Sustained-Release Tablets
Riboflavin Sodium Phosphate Group
Active Comparator group
Description:
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.
Treatment:
Drug: Riboflavin Sodium Phosphate Injection

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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