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Trial record 16 of 400 for:    sodium phosphate

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

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ClinicalTrials.gov Identifier: NCT02769494
Recruitment Status : Unknown
Verified January 2016 by Yongquan Shi, Xijing Hospital of Digestive Diseases.
Recruitment status was:  Recruiting
First Posted : May 11, 2016
Last Update Posted : May 11, 2016
Sponsor:
Information provided by (Responsible Party):
Yongquan Shi, Xijing Hospital of Digestive Diseases

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.

Condition or disease Intervention/treatment Phase
Crohn's Disease Oral Ulcer Drug: Mesalazine Sustained-Release Tablets Drug: Riboflavin Sodium Phosphate Injection Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Efficacy of Topically Applied Mesalazine Sustained-Release Tablets in Oral Lesions of Crohn's Disease
Study Start Date : March 2016
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : January 2017


Arm Intervention/treatment
Experimental: Mesalazine Group
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
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.
Other Name: Pentasa

Active Comparator: Riboflavin Sodium Phosphate Group
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
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.




Primary Outcome Measures :
  1. 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.

  2. oral ulcer recurrence [ Time Frame: the 28 Days after the end of treatment. ]
    to observe the recurrence rate of ulcer


Secondary Outcome Measures :
  1. symptoms effective rates [ Time Frame: At the 7 Days of the treatment, and the 28 Days after the end of treatment. ]
    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.

  2. adverse events [ Time Frame: From 1st Day to 7th Days of the treatment and the 28 Days after the end of treatment. ]
    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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02769494


Contacts
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Contact: Ying Han +86-29-84771539 hanying@fmmu.edu.cn

Locations
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China, Shaanxi
Xijing Hospital Recruiting
Xi'an, Shaanxi, China, 710032
Contact: Yongquan Shi, Ph. D    +86-29-84771515    shiyquan@fmmu.edu.cn   
Sponsors and Collaborators
Xijing Hospital of Digestive Diseases
Investigators
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Study Director: Ying Han, Ph. D Degistive Disease of Xijing Hospital, Fourth Military Medical University

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Responsible Party: Yongquan Shi, Doctor of Xijing Hospital of Digestive Diseases,Principal, Xijing Hospital of Digestive Diseases
ClinicalTrials.gov Identifier: NCT02769494     History of Changes
Other Study ID Numbers: KY20160107-1
First Posted: May 11, 2016    Key Record Dates
Last Update Posted: May 11, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Yongquan Shi, Xijing Hospital of Digestive Diseases:
Oral ulcer
Crohn's disease

Additional relevant MeSH terms:
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Ulcer
Crohn Disease
Oral Ulcer
Pathologic Processes
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Mouth Diseases
Stomatognathic Diseases
Riboflavin
Flavin Mononucleotide
Mesalamine
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Photosensitizing Agents
Dermatologic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents