Safety and Efficacy of AST-120 in Mild to Moderate Crohn's Patients With Fistulas
Public ClinicalTrials.gov record NCT00321412. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Double-blind, Randomized, Placebo-controlled Multicenter Study to Assess the Safety and Efficacy of AST-120 in Mild to Moderately Active Crohn's Patients With Fistulas
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The objective of this study is to evaluate the safety and effectiveness of the experimental drug AST-120 in treating patients with mild to moderately severe Crohn's disease who have fistulas. The study will test whether or not patients receiving AST-120 experience a greater reduction in number of draining fistulas and improvement of their other Crohn's disease symptoms versus patients who receive placebo (material that does not contain any active medication).
Study identification
- NCT ID
- NCT00321412
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 191 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 70 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 2006 (Type not available)
- Primary completion
- Mar 2008 (Actual)
- Completion
- Sep 2008 (Actual)
- Last update posted
- May 30, 2014
2006 – 2008
United States locations
- U.S. sites
- 25
- U.S. states
- 17
- U.S. cities
- 23
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Advanced Clinical Research Institute | Anaheim | California | 92801 | — |
| Digestive Care Medical Center | San Carlos | California | 94070 | — |
| Shafran Gasteroenterology Center | Winter Park | Florida | 32789 | — |
| Rush University Medical Center | Chicago | Illinois | 60612 | — |
| University of Chicago Medical Center | Chicago | Illinois | 60637-1426 | — |
| Indiana University, Outpatient Clinical Research Facility | Indianapolis | Indiana | 46202 | — |
| University of Kentucky Chandler Medical Center | Lexington | Kentucky | 40536 | — |
| University of Louisville, Department of Surgery | Louisville | Kentucky | 40202 | — |
| Metropolitan Gastroenterology Group/Chevy Chase Clinical Research | Chevy Chase | Maryland | 20815 | — |
| Brigham & Women's Hospital | Boston | Massachusetts | 02115 | — |
| Clinical Research Institute of Michigan, LLC | Chesterfield | Michigan | 48047 | — |
| Drs. Scherf, Chessler, Zingler & Spinnell, MD, PA | Fort Lee | New Jersey | 07024 | — |
| Long Island Clinical Research Associates, LLP | Great Neck | New York | 11021 | — |
| Mount Sinai School of Medicine, IBD Research Center | New York | New York | 10028 | — |
| University of Rochester Medical Center | Rochester | New York | 14642 | — |
| University of North Carolina | Chapel Hill | North Carolina | 27514 | — |
| Carolina Digestive Health Associates | Charlotte | North Carolina | 28211 | — |
| University Hospitals of Cleveland | Cleveland | Ohio | 44106 | — |
| Cleveland Clinic - Department of Gastroenterology | Cleveland | Ohio | 44195 | — |
| The Penn State University, Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | — |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | — |
| Digestive Disease Center/MUSC | Charleston | South Carolina | 29425 | — |
| Memphis Gastroenterology Group, PC | Germantown | Tennessee | 38138 | — |
| University of Washington | Seattle | Washington | 98195 | — |
| Dean Foundation Research Center | Madison | Wisconsin | 53715 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 63 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00321412, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 30, 2014 · Synced Oct 21, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00321412 live on ClinicalTrials.gov.