Examination of efficacy and safety of new 5-ASA preparation for ulcerative colitis, and new method of evaluating disease condition by measuring fecal concentration of calprotectin.

Examination of efficacy and safety of new 5-ASA preparation for ulcerative colitis, and new method of evaluating disease condition by measuring fecal concentration of calprotectin. - Establishing the efficacy evaluating method of Asacol for ulcerative colitis by measuring fecal concentration of calprotectin.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000005823

Enrollment

Registered

2011-06-21

Start date

2011-07-01

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

The efficacy and the safety of the Asacol is examined by administering Asacol 2.4g/day switching from Pentasa 3g/day, and the medication of Asacol is continued for 12 weeks if at all possible. The ef

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Mild and moderate ulcerative colitis patients taking Pentasa medication in combination with the steroid preparation or the topical formulation.

Exclusion criteria

Exclusion criteria: (1)Patients without agreement of this study (2)Pregnant women and women suspected of being pregnant (3)Patients with history of total or partial colectomy operation.

Design outcomes

Primary

Measure	Time frame
non-relapse rate by CAI score after three months	—

Secondary

Measure	Time frame
Clinical Activity Index Patient Diary Non-relapse rate after 1,2,3 months Inflammatory response score (WBC,Plt, ESR, CRP) Safety Remission period (month)	—

Countries

Japan

Contacts

Public ContactTaro Osada

Juntendo University Department of Gastroenterology,

otaro@juntendo.ac.jp03-3813-3111

Outcome results

None listed

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