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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: Completed Phase 3 study of Crohn's Disease, sponsored by Otsuka America Pharmaceutical.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Clinical Remission is defined as a Crohn's Disease Activity Index (CDAI) score of ≤150 when evaluated at Week 12
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
| Field | Value |
|---|---|
| Enrollment Target | 235 participants |
| Start Date | 2005-01 |
| Est. Completion | 2007-12 |
| Phase | Phase 3 |
What the finished NCT00162942 record still lists
NCT00162942 is an interventional study that assigns participants to a tested intervention. The registered 235 participants enrollment target is mid-sized for trials with a published cap, below the 2,392-participant average among 105 other Crohn's Disease trials with a reported enrollment target (90% lower).
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 names 20 study sites across 15 states, led by 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.
Learn More About Clinical Trials
Similar trials for Crohn's Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00162942's enrollment target sits among peer trials
235 49th of 105 higher than 57 of 105 other Crohn's Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Crohn's Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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