Randomized controlled study for concomitant use of 5-aminosalicylic acid suppository with increased dose of oral 5-aminosalicylic acid for moderate to severe patients with ulcerative colitis

Randomized controlled study for concomitant use of 5-aminosalicylic acid suppository with increased dose of oral 5-aminosalicylic acid for moderate to severe patients with ulcerative colitis - Randomized controlled study for concomitant use of 5-ASA suppository with increased dose of oral 5-ASA for moderate to severe patients with ulcerative colitis

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000019310

Enrollment

Registered

2015-11-01

Start date

2015-11-01

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

Arm A: Increase of oral 5-ASA (oral administration of 5-ASA in a maximum dose for 8 weeks) Arm B: Increase of oral 5-ASA and addition of 5-ASA suppository (oral administration of 5-ASA in a maximum do

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Moderate to severe activity (total Mayo score of 3-8) with administrating maintenance dose of oral 5-ASA (not greater than 3.0g of Pentasa or 2.4 g of Asacol). Rectal inflammation with Mayo endoscopic subscore of 1 or more.

Exclusion criteria

Exclusion criteria: Coexisting infectious colitis History of administrating more than 3.0 g of oral 5-ASA, topical 5-ASA, oral corticosteroid, tacrolimus before 30 days of enrollment History of receiving anti-TNF therapy before 60 days of enrollment Regularly administrating NSAIDs before 7 days of enrollment History of administrating topical corticosteroid before 7 days of enrollment Severe renal/liver dysfunction History of allergy for 5-ASA Concomitant malignant disease With pregnancy or lactation Judged as inadequate for this study by the researchers

Design outcomes

Primary

Measure	Time frame
The change in partial Mayo score after 4 weeks of therapy	—

Countries

Japan

Contacts

Public ContactYuko Sakakibara

National Hospital Organization Osaka National Hospital Department of Gastroenterology

yuko.s@onh.go.jp06-6942-1331

Outcome results

None listed

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