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Observational Study on Clinical Practice in the Management of Ulcerative Colitis with Oral 5-Aminosalicylic Acid in Japan

Observational Study on Clinical Practice in the Management of Ulcerative Colitis with Oral 5-Aminosalicylic Acid in Japan - OPTIMUM Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000008563
Enrollment
5000
Registered
2012-07-30
Start date
2012-09-04
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

None listed

Sponsors

Kyorin Pharmaceutical Co.,Ltd
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Outpatients 2) Adult patients who have been diagnosed with mild to moderate active ulcerative colitis or ulcerative colitis in the remission stage according to the diagnostic criteria for ulcerative colitis (draft revised on February 13, 2010) 3) Patients who have been treated with remission induction therapy or remission maintenance therapy with oral 5-ASA drugs (Pentasa® tablets 250 mg, Pentasa® tablets 500 mg, Asacol® tablets 400 mg and Salazopyrin® tablets 500 mg as well as drugs that have been proved equivalent to these drugs) 4) Patients who have received adequate information regarding this study and understood thoroughly, and then voluntarily submitted written consent forms upon participation in this study

Exclusion criteria

Exclusion criteria: 1) Patients with severe active ulcerative / fulminant ulcerative colitis according to the diagnostic criteria for ulcerative colitis (draft revised on February 13, 2012) 2) Patients who have received total / subtotal colectomy 3) Patients who have been complicated with malignant tumor 4) Patients who are pregnant or possibly pregnant 5) Other patients whom investigators and subinvestigators considered inappropriate to participate in this study

Design outcomes

Primary

MeasureTime frame
Cumulative non-relapse rate

Secondary

MeasureTime frame
1)Number of relapses 2)Duration of remission maintained (days) 3)The pUCDAI scores and the scores that constitute these pUCDAI scores at each assessment period 4)Medication adherence

Countries

Japan

Contacts

Public ContactMichiaki Ota

Kyorin Pharmaceutical Co.,Ltd Medical Affairs

michiaki.oota@mb.kyorin-pharm.co.jp03-3525-4787

Outcome results

None listed

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