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 - 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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000026175

Enrollment

Registered

2017-03-01

Start date

2017-06-23

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative colitis

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients with remission, mild or moderate ulcerative colitis (endoscopic Mayo score 2 or less, or less severe classification by Suzuki team of the Ministry of Health, Labor and Welfare) 2) Patients who aged 20 years or older at the time of acquiring consent. 3) Patients who have not changed the contents of medication to the original disease within the last 8 weeks of participation in this study. 4) Time-dependent mesalazine granule preparation 2.0 - 4.0 mg / day or pH dependent mesalazine tablet 2.4 - 4.8 mg / day Patients who received written informed consent.

Exclusion 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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Countries

Japan

Contacts

Public ContactAkira Harada

Kyushu University Department of Medicine and Clinical Science, Graduate School of Medical Sciences

akharada@intmed2.med.kyushu-u.ac.jp092-642-5261

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026