Safety and Efficacy of Two Different Doses of Asacol in the Treatment of Moderately Active Ulcerative Colitis
Public ClinicalTrials.gov record NCT00073021. 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, 6-Week, Parallel-Group Design Clinical Trial to Assess Safety and Efficacy of Asacol 4.8 g/Day (800 mg Tablet) Versus Asacol 2.4 g/Day (400 mg Tablet) for the Treatment of Moderately Active Ulcerative Colitis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study is a prospective clinical study to evaluate the safety and efficacy of two different doses of Asacol for the treatment of moderately active ulcerative colitis. In addition, a new tablet formulation will be evaluated at one of the two doses.
Study identification
- NCT ID
- NCT00073021
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 386 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 75 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
- Sep 2000 (Type not available)
- Primary completion
- Sep 2003 (Actual)
- Completion
- Sep 2003 (Actual)
- Last update posted
- Jun 29, 2015
2000 – 2003
United States locations
- U.S. sites
- 54
- U.S. states
- 25
- U.S. cities
- 50
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Mayo Clinic Scottsdale | Scottsdale | Arizona | 85259 | — |
| AGMG Clinical Research | Anaheim | California | 92801 | — |
| Research Site | Los Angeles | California | 90067 | — |
| Community Clinical Trials | Orange | California | 38305 | — |
| AGMG Clinical Research | Orange | California | 92869 | — |
| Research Site | Sacramento | California | 95825 | — |
| Sharp Rees-Stealy Medical Group | San Diego | California | 92123 | — |
| Research Site | Arvada | Colorado | 80002 | — |
| Research Site | Englewood | Colorado | 80110 | — |
| Center for Medical Research, LLC | Manchester | Connecticut | 06040 | — |
| Center for GI Disorders | Hollywood | Florida | 33021 | — |
| Research Site | Maitland | Florida | 32789 | — |
| Advanced Gastroenterology Associates | Palm Harbor | Florida | 34684 | — |
| Research Site | Zephyrhills | Florida | 33540 | — |
| Southeast Research Associates | Marietta | Georgia | 30067 | — |
| University of Chicago Medical Center | Chicago | Illinois | 60637 | — |
| GI Research | Metairie | Louisiana | 70001 | — |
| Louisiana Research Center | Shreveport | Louisiana | 71103 | — |
| Digestive Disorders Associates | Annapolis | Maryland | 21401 | — |
| Research Site | Baltimore | Maryland | 21215 | — |
| Digestive Disease Associates | Baltimore | Maryland | 21229 | — |
| Metropolitan Gastroenterology Group | Chevy Chase | Maryland | 20815 | — |
| Brigham & Women's Hospital | Boston | Massachusetts | 02115 | — |
| Henry Ford Hospital | Detroit | Michigan | 48202 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| PharmaTrials, Inc. | Hillsborough | New Jersey | 08844 | — |
| Research Site | Forest Hills | New York | 11375 | — |
| Long Island Clinical Research Associates | Great Neck | New York | 11021 | — |
| Research Site | New York | New York | 10128 | — |
| Carolinas Digestive Health Associates | Charlotte | North Carolina | 28262 | — |
| Research Site | Raleigh | North Carolina | 27612 | — |
| Research Site | Statesville | North Carolina | 28677 | — |
| Consultants for Clinical Research | Cincinnati | Ohio | 45219 | — |
| Research Site | Cincinnati | Ohio | 45267 | — |
| Research Site | Columbus | Ohio | 43215 | — |
| GI & Liver Consultants | Dayton | Ohio | 45440 | — |
| Research Site | Oklahoma City | Oklahoma | 73190 | — |
| Research Site | Tulsa | Oklahoma | 74135 | — |
| West Hills Gastroenterology Group | Portland | Oregon | 97225 | — |
| Research Site | Altoona | Pennsylvania | 16602 | — |
| Research Site | Hanover | Pennsylvania | 17331 | — |
| Regional Research Institute | Jackson | Tennessee | 38305 | — |
| Research Site | Austin | Texas | 78705 | — |
| Research Site | Dallas | Texas | 75246 | — |
| Research Site | Houston | Texas | 77030 | — |
| Houston Medical Research Associates | Houston | Texas | 77090 | — |
| Research Site | Temple | Texas | 76508 | — |
| Research Site | Ogden | Utah | 84405 | — |
| Charlottesville Medical Research | Charlottesville | Virginia | 22902 | — |
| Research Site | Fairfax | Virginia | 22031 | — |
| Research Site | Fredericksburg | Virginia | 22401 | — |
| Richmond GI Research | Richmond | Virginia | 23226 | — |
| Research Site | Spokane | Washington | 99207 | — |
| Wisconsin Center for Advanced Research | Milwaukee | Wisconsin | 53207 | — |
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 3 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00073021, 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 Jun 29, 2015 · Synced Oct 23, 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 NCT00073021 live on ClinicalTrials.gov.