A Dose-finding Study of OPC-6535 in Patients With Active Ulcerative Colitis

A dose-finding study of OPC-6535 in patients with active ulcerative colitis

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080220212

Enrollment

160

Registered

2006-03-02

Start date

2006-06-26

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

Active ulcerative colitis

Interventions

investigational material(s) Generic name etc : OPC-6535 INN of investigational material : - Therapeutic category code : 239 Other agents affecting digestive organs Dosage and Administration for Invest

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Patients with active ulcerative colitis, (2) Age: 18 to less than 65 years (at time of informed consent), (3) Patients who have been receiving an oral 5-ASA formulation at a fixed regimen and at a fixed dose, (4) Either inpatient or outpatient

Exclusion criteria

Exclusion criteria: -

Design outcomes

Primary

Measure	Time frame
efficacy Clinical improvement rate after 8 weeks of study drug administration	—

Secondary

Measure	Time frame
efficacy 1. Remission rate 2. Mean change from the baseline in total Disease Activity Index (DAI) score 3. Mean change from the baseline in DAI subscores 4. Mean change from the baseline in total Clinical Activity Index (CAI) score 5. Mean change from the baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) score 6. Mean change from the baseline in IBDQ subscale scores 7. Clinical improvement rate after 4 weeks of study drug administration	—

Measure

Time frame

efficacy 1. Remission rate 2. Mean change from the baseline in total Disease Activity Index (DAI) score 3. Mean change from the baseline in DAI subscores 4. Mean change from the baseline in total Clinical Activity Index (CAI) score 5. Mean change from the baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) score 6. Mean change from the baseline in IBDQ subscale scores 7. Clinical improvement rate after 4 weeks of study drug administration

—

Countries

Japan

Outcome results

None listed

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