Crohn's DiseasePhase 3NCT02769494
The Efficacy of Topical Mesalazine Sustained-Release Tablets in Crohn's Disease Patients With Oral Ulcer
A Phase 3 study testing Mesalazine Sustained-Release Tablets and Riboflavin Sodium Phosphate Injection in people with Crohn's Disease and Oral Ulcer, run by Xijing Hospital of Digestive Diseases at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Crohn's Disease, Oral Ulcer
- What is being tested?
- Mesalazine Sustained-Release Tablets and Riboflavin Sodium Phosphate Injection
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- Mar 2016to Jan 2017
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18~65, both gender.
- Patients with oral ulcer and confirmed Crohn's disease.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of Topically Applied Mesalazine Sustained-Release Tablets in Oral Lesions of Crohn's Disease
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.
Read the detailed 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.
- Conditions
- Crohn's Disease, Oral Ulcer
- Being tested
- Mesalazine Sustained-Release Tablets, Riboflavin Sodium Phosphate Injection
- Keywords
- Oral ulcer, Crohn's disease
- Medical subject headings
- Crohn Disease, Oral Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mesalazine Sustained-Release TabletsDrug
Also called Pentasa
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Riboflavin Sodium Phosphate Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: the 7 Days of treatment.
oral ulcer recurrence
to observe the recurrence rate of ulcer
Measured: the 28 Days after the end of treatment.
Secondary outcomes (2)
symptoms effective rates
Symptom effective rate =（total score before treatment - total score after treatment）/total score before treatment x 100%. Total score = frequency + severity. Frequency score is calculated by all the frequency of oral pain, anorexia,and eating difficult. Severity is accumulated by the degree of symptoms described above,which is divided to 4 degree as 0 presenting none,and 3 presenting most severe.
Measured: At the 7 Days of the treatment, and the 28 Days after the end of treatment.
adverse events
Participants with Adverse Events as a Measure of Safety and Tolerability. The common side effects of the study include headache, diarrhea, nausea, abdominal pain, vomiting and skin rash.
Measured: From 1st Day to 7th Days of the treatment and the 28 Days after the end of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2016 (estimated)
- Study startMar 2016
- Primary completionDec 2016
- Study completionJan 2017
Why it stopped: Lack of funds
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital of Digestive Diseases
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yongquan Shi, Xijing Hospital of Digestive Diseases
- Investigators
- Ying Han, Ph. D, Study director, Degistive Disease of Xijing Hospital, Fourth Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02769494
- Sponsor's protocol ID
- KY20160107-1
- Status last verified
- Jan 2023
- First submitted
- 9 Mar 2016
- Last updated
- 1 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Topically Applied Mesalazine Sustained-Release Tablets in Oral Lesions of Crohn's Disease
- ClinicalTrials.gov ID
- NCT02769494
- Acronym / sponsor ID
- KY20160107-1
- Conditions
- Crohn's Disease, Oral Ulcer
- Keywords
- Oral ulcer, Crohn's disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of funds
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Xijing Hospital of Digestive DiseasesUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 11 May 2016 (estimated)
- 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.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mesalazine Group | Experimental | Drug: Mesalazine Sustained-Release TabletsMesalazine 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. |
| Riboflavin Sodium Phosphate Group | Active comparator | Drug: Riboflavin Sodium Phosphate Injectionwipe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age between 18~65, both gender.
- Patients with oral ulcer and confirmed Crohn's disease.
Key exclusion criteria (6 listed)
- 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.
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 |
|---|---|---|
| Mesalazine Sustained-Release TabletsAlso: PentasaMesalazine 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. | Drug | Mesalazine Group |
| Riboflavin Sodium Phosphate Injectiongently 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. | Drug | Riboflavin Sodium Phosphate Group |
Primary outcome
oral ulcer healing
Time frame: the 7 Days of treatment.
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.
oral ulcer recurrence
Time frame: the 28 Days after the end of treatment.
to observe the recurrence rate of ulcer
2 secondary outcomes
symptoms effective rates
Time frame: At the 7 Days of the treatment, and the 28 Days after the end of treatment.
adverse events
Time frame: From 1st Day to 7th Days of the treatment and the 28 Days after the end of treatment.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2023.
- Individual participant dataSharing planned: No
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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.
Ying Han, Ph. D study director
Degistive Disease of Xijing Hospital, Fourth Military Medical University
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 Mesalazine Sustained-Release Tablets and Riboflavin Sodium Phosphate Injection in people with Crohn's Disease and Oral Ulcer, run by Xijing Hospital of Digestive Diseases at 1 site in China.
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 2 inclusion and 6 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: withdrawn, as of the sponsor's last update on 1 Feb 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 China. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
oral ulcer healing (time frame: the 7 Days of treatment.). The study lists 2 primary outcomes in all. 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 1 Feb 2023.