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NCT00162942 · ClinicalTrials.gov registry record · Phase 3

Study for the Treatment of Crohn's Disease With Adacolumn

A Phase 3 study of Crohn's Disease, sponsored by Otsuka America Pharmaceutical.

Completed
Registry status
Phase 3
Development phase
235
Enrollment target
20
Study locations

NCT00162942 is a Phase 3 study of Crohn's Disease that has completed, run by Otsuka America Pharmaceutical. The registered enrollment target is 235 participants, below the 2,392-participant average among 105 other Crohn's Disease trials with a reported enrollment target (90% lower). The trial reports 20 study locations across 15 states.

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The verdict

NCT00162942, a Phase 3 study of Crohn's Disease, has completed, sponsored by Otsuka America Pharmaceutical.

COMPLETED
Registry status
Phase 3
Development phase
235 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is to evaluate the safety and effectiveness of the Adacolumn Apheresis System as a treatment for the signs and symptoms of Crohn's disease.

Conditions Studied

Interventions

  • DEVICE Sham
  • DEVICE Adacolumn

Study Locations (20)

California

  • Capitol Gastroenterology Consultants Medical Group - Roseville
  • UCSF Mount Zion Medical Center - San Francisco

Maryland

  • Johns Hopkins University - Baltimore
  • Metropolitan Gastroenterology Group - Chevy Chase

Michigan

  • University of Michigan - Ann Arbor
  • Clinical Research Institute of Michigan - Clinton Township

North Carolina

  • University of North Carolina, Division of Digestive Disease & Nutrition - Chapel Hill
  • Duke University Medical Center - Durham

Ohio

  • Consultants for Clinical Research - Cincinnati
  • Cleveland Clinic Foundation - Cleveland

Arizona

  • Mayo Clinic Scottsdale - Phoenix

Colorado

  • Rocky Mountain Gastroenterology Associates, PC - Wheat Ridge

Connecticut

  • Medical Research Institute of Connecticut - Hamden

Trial Details

FieldValue
Enrollment Target 235 participants
Start Date 2005-01
Est. Completion 2007-12
Phase Phase 3

Sponsor

Otsuka America Pharmaceutical

10 total trials

What the Registry Record Tells You About NCT00162942

The ClinicalTrials.gov registry entry for NCT00162942 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 235 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,392-participant average among 105 other Crohn's Disease trials with a reported enrollment target (90% lower). The listed sponsor is Otsuka America Pharmaceutical, which has 10 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Crohn's Disease appearing as the primary indexed condition, and to 2 interventions - of which Sham is the first listed.

NCT00162942 reports 20 study locations spanning 15 distinct geographic areas - top geographies include California, Maryland, Michigan.

Frequently Asked Questions

What is clinical trial NCT00162942 about?

NCT00162942 is a clinical study titled "Study for the Treatment of Crohn's Disease With Adacolumn". The purpose of this study is to evaluate the safety and effectiveness of the Adacolumn Apheresis System as a treatment for the signs and symptoms of Crohn's disease.

What is the current status of trial NCT00162942?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 235 participants. The study started on 2005-01. Estimated completion is 2007-12.

What conditions does trial NCT00162942 study?

This clinical trial studies the following conditions: Crohn's Disease.

What interventions are being tested in trial NCT00162942?

The interventions under investigation include: Sham (DEVICE), Adacolumn (DEVICE).

Who is sponsoring clinical trial NCT00162942?

This trial is sponsored by Otsuka America Pharmaceutical, which has 10 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00162942 being conducted?

This trial has 20 study locations across Arizona, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Crohn's Disease

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.