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A Dose-finding and Confirmatory Trial of OPC-6535 in Patients With Active Crohn's Disease

Information source: Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Crohn's Disease

Intervention: Placebo (Drug); OPC-6535 (Drug); OPC-6535 (Drug)

Phase: Phase 2/Phase 3

Status: Completed

Sponsored by: Otsuka Pharmaceutical Co., Ltd.

Official(s) and/or principal investigator(s):
Katsuhisa Saito, Study Chair, Affiliation: OPCJ

Summary

The purpose of this study is to verify the safety and efficacy of OPC-6535 and determine the optimal dose by once-daily oral administration of OPC-6535 at 25 or 50 mg or placebo for 8 weeks in combination with base treatment (either a fixed oral dose of 5-aminosalicylic acid [5-ASA] or a fixed oral dose of 5-ASA plus enteral nutrition) in 180 patients with active Crohn's disease.

Clinical Details

Official title: A Multinational, Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-finding and Confirmatory Trial of OPC-6535 in Patients With Active Crohn's Disease

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Clinical improvement rate (number of subjects showing clinical improvement / number of subjects evaluated x 100)

Secondary outcome:

Clinical improvement rate

Remission rate

Mean change in CRP level from the baseline

Clinical laboratory tests

Eligibility

Minimum age: 18 Years. Maximum age: 64 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Primary lesion in either small intestine or large intestine

- C-reactive protein (CRP) level above the upper limit of the normal range

- Patients who have been receiving a 5-ASA formulation (oral mesalazine) at a fixed

dose of 2. 25 g/day or higher (not exceeding the approved dose) and at a fixed dosing regimen

- Patients who have not received enteral nutrition or who have been receiving enteral

nutrition at a fixed intake of 1200 kcal/day or less Exclusion Criteria:

- Patients with an uncontrolled external fistula (including anal fistula)

- Patients with a history of total proctocolectomy or subtotal colectomy

- Patients with short bowel syndrome

- Patients with an artificial anus

- Patients with serious infectious disease (intra-abdominal abscess, etc)

- Patients with malignant tumor

- Female patients who are pregnant, lactating, or possibly pregnant, or who wish to

become pregnant during the trial period

Locations and Contacts

Chubu Region, Japan

Chugoku Region, Japan

Hokkaido Region, Japan

Kanto Region, Japan

Kinki Region, Japan

Kyushu Region, Japan

Tohoku Region, Japan

Busan, Korea, Republic of

Daegu, Korea, Republic of

Gyronggi-do, Korea, Republic of

Seoul, Korea, Republic of

Additional Information

Starting date: October 2009
Last updated: February 19, 2013

Page last updated: August 20, 2015

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