Completed PHASE3 INTERVENTIONAL NCT00092508

CORE: A Study of OPC-6535 With Asacol® in Maintaining Ulcerative Colitis (UC) Remission

Phase 3, Multi-Center, Randomized, Double-Blind, Parallel-Arm, 52-Week Dose Comparison Study of the Efficacy and Safety of 25 mg QD and 50 mg QD of OPC-6335 Oral Tablets and 800 mg BID of Asacol® in the Maintenance of Ulcerative Colitis Remission

Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Conditions Ulcerative Colitis

Interventions Asacol® OPC-6535

Updated 6 times since 2017 Last updated: Jun 19, 2007 Started: May 31, 2004 Completion: May 31, 2007

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE3 trial investigates Ulcerative Colitis and is currently completed. Otsuka Pharmaceutical Development & Commercialization, Inc. leads this study, which shows 6 recorded versions since 2004 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

Change History

6 versions recorded

Sep 2025 — Present [monthly]

Completed PHASE3
Sep 2024 — Sep 2025 [monthly]

Completed PHASE3
Jul 2024 — Sep 2024 [monthly]

Completed PHASE3
Jan 2021 — Jul 2024 [monthly]

Completed PHASE3
Jun 2018 — Jan 2021 [monthly]

Completed PHASE3

▶ Show 1 earlier version

Jan 2017 — Jun 2018 [monthly]

Completed PHASE3

First recorded

May 2004

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Otsuka Pharmaceutical Development & Commercialization, Inc.

Data source: Otsuka Pharmaceutical Development & Commercialization, Inc.

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Annapolis, United States , Asheville, United States , Braintree, United States , Charleston, United States , Charlotte, United States , Chesterfield, United States , Chevy Cha, United States , Dayton, United States , Egg Harbor, United States , Great Neck, United States and 16 more locations