Comparison of concentration of 5-ASA and acetyl 5-ASA in mucosa in time-dependent mesalazine granule preparation and pH-dependent mesalazine tablet for patients with ulcerative colitis

• Register: JPRN
• Last refreshed on: 17 October 2023
• Main ID: JPRN-UMIN000026175
• Date of registration: 01/03/2017
• Prospective Registration: Yes
• Primary sponsor: Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University
• Public title: Comparison of concentration of 5-ASA and acetyl 5-ASA in mucosa in time-dependent mesalazine granule preparation and pH-dependent mesalazine tablet for patients with ulcerative colitis
• Scientific title: Comparison of concentration of 5-ASA and acetyl 5-ASA in mucosa in time-dependent mesalazine granule preparation and pH-dependent mesalazine tablet for patients with ulcerative colitis - Comparison of concentration of 5-ASA and acetyl 5-ASA in mucosa in time-dependent mesalazine granule preparation and pH-dependent mesalazine tablet for patients with ulcerative colitis
• Date of first enrolment: 2017/06/23
• Target sample size: 60
• Recruitment status: Complete: follow-up complete
• URL: https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030077
• Study type: Interventional
• Study design: Parallel Non-randomized
• Phase: Not applicable

Countries of recruitment

Japan

Contacts

• Name: Tnakanari Kitazono
• Affiliation: Kyushu University Department of Medicine and Clinical Science, Graduate School of Medical Sciences

• Name: Akira Harada
• Affiliation: Kyushu University Department of Medicine and Clinical Science, Graduate School of Medical Sciences

Key inclusion & exclusion criteria

Inclusion criteria:
Exclusion criteria: 1) People with severe or fulminant ulcerative colitis. (Mayo score 2 or less, or less severe classification by Suzuki team of Ministry of Health, Labor and Welfare) 2) Patients undergoing total colon resection, subtotal puncture surgery etc. 3) Patients with liver dysfunction and renal dysfunction. 4) Patients undergoing antithrombotic therapy or anticoagulant therapy and patients with thrombocytopenia. 5) Pregnant women or patients who may be pregnant, breast-feeding patients. 6) Patients who are merging psychosis or psychiatric symptoms and are considered difficult to participate in the study. 7) Other patients who decided that the doctor in charge is inappropriate, such as a decline in compliance.

Age minimum: 20years-old
Age maximum: 99years-old
Gender: Male and Female

Health Condition(s) or Problem(s) studied

Ulcerative colitis

Intervention(s)

Time dependent mesalazine granule formulation After bottom of the 8th week from the start of administration, the lower endoscopy was performed and the mucous membrane was collected from the cecum and rectum by biopsy and the concentration of 5-ASA and acetyl 5-ASA in the mucosa was measured in the mucosa .
PH dependent mesalazine granule preparation Lower endoscopy was performed 8 weeks after the start of administration, mucosa was collected from the cecum and rectum by biopsy, and the concentration of 5-ASA and acetyl 5-ASA in the mucosa was measured at the drug part .

Primary Outcome(s)

Changes in the concentrations of 5-ASA and acetyl 5-ASA in rectal, cecal biopsy tissue, remission induction rate / maintenance rate (Mayo 1 or less)

Secondary Outcome(s)

Drug efficacy rate (improvement of CAI by 30% or more), remission maintenance rate and duration, side effect occurrence rate, endoscopic findings, CRP, change amount of calprotectin in the stool

Source(s) of Monetary Support

Kyushu University

Ethics review

Status: YES
Approval date: 17/02/2017
Contact:

Results

• Date Completed: 08/03/2019
• URL: http://www.gut.med.kyushu-u.ac.jp/