Study for the Treatment of Ulcerative Colitis With Adacolumn (Companion to US Study 512-04-205)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Study Completion Date

2006-06-30

Brief Summary

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The purpose of the study is to demonstrate the safety and effectiveness of the Adacolumn Apheresis System to treat the signs and symptoms of ulcerative colitis.

Detailed Description

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Study Type: Interventional Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study.

Conditions

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Ulcerative Colitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Adacolumn Apheresis System

Intervention Type DEVICE

Eligibility Criteria

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Eligible Sex

Accepts Healthy Volunteers

No

Principal Investigators

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Robert Lofberg, Prof.

Role: PRINCIPAL_INVESTIGATOR

IBD-unit, Dept. of Gastroenterology, HMQ Sophia Hospital, Stockholm, Sweden

Toshifumi Hibi, Prof.

Role: PRINCIPAL_INVESTIGATOR

Keio University, Tokyo, Japan

Countries

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Austria Belgium Denmark France Germany Italy Japan Norway Spain Sweden United Kingdom

Other Identifiers

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512-04-205-CS

Identifier Type: -

Identifier Source: org_study_id