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Segmental Endoscopic Evaluation of Combined Oral and Topical Mesalazine (Pentasa®) in patients with mild-to-moderate Ulcerative Colitis (UC)

Segmental Endoscopic Evaluation of Combined Oral and Topical Mesalazine (Pentasa®) in patients with mild-to-moderate Ulcerative Colitis (UC) - Segmental Endoscopic Evaluation in patients with mild-to-moderate UC

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000010168
Enrollment
60
Registered
2013-03-08
Start date
2011-03-01
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

Combination therapy of oral Pentasa 4g/day with Pentasa enema 1g/day for 8 weeks

Sponsors

Toho University Sakura Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients with active mild-to-moderate UC 2) Patients treated with oral mesalazine (≤ 4g/day) or oral sulfasalazine (≤ 4.5g/day)

Exclusion criteria

Exclusion criteria: 1)Patients receiving topical mesalazine, topical sulfasalazine within 14 days prior to study entry 2)Patients receiving any steroid within 14 days prior to study entry 3)Patients treated with immunosuppressive agents or anti TNF-a antibody during 90 days prior to study enrolment 4)Patients receiving cytapheresis within 14 days prior to study entry 5)Patients who have allergy to salicylates 6)Patients who have experienced serious adverse effect elicited by mesalazine 7)Patients who have complicated malignant disease 8)Patients who are pregnant or possibly pregnant 9)Patients suspected to remain the effect of intervention in other clinical researches 10)Patients who have any condition that might interfere with study assessments, judged by the investigator.

Design outcomes

Primary

MeasureTime frame
Mucosal healing defined as Mayo endoscopic score = 0, 1—

Secondary

MeasureTime frame
Endoscopic improvement by segmental endoscopic evaluation Improvement of disease activity in UCDAI score and/or UCDAI sub-scores—

Countries

Japan

Contacts

Public ContactYasuo Suzuki

Toho University Sakura Medical Center Gastroenterology Center

yasuo-suzuki@sakura.med.toho-u.ac.jp043-462-8811

Outcome results

None listed

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