Assessing the Safety/Efficacy of Asacol® Given Every 12 Hours to Children and Adolescents for the Maintenance of Remission of Ulcerative Colitis
Public ClinicalTrials.gov record NCT01004185. 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 Randomized, Double-blind, Parallel-group Study to Assess the Safety and Efficacy of Asacol® (1.2 to 4.8g/Day) 400 mg Delayed-release Tablets Given Twice Daily for 26 Weeks to Children and Adolescents for the Maintenance of Remission of Ulcerative Colitis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to determine whether low dose Asacol® (27 mg/kg - 71 mg/kg) and high dose Asacol® (53 mg/kg - 118 mg/kg) are safe and effective when dosed as 400 mg delayed-release tablets given twice daily for 26 weeks to children and adolescents for the maintenance of remission of ulcerative colitis.
Study identification
- NCT ID
- NCT01004185
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 39 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 5 Years to 17 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
- Oct 2009 (Type not available)
- Primary completion
- Mar 2011 (Actual)
- Completion
- Mar 2011 (Actual)
- Last update posted
- May 25, 2012
2009 – 2011
United States locations
- U.S. sites
- 25
- U.S. states
- 18
- U.S. cities
- 24
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Research Site | Birmingham | Alabama | 35233 | — |
| Research Site | Phoenix | Arizona | 85016 | — |
| Research Site | Loma Linda | California | 92354 | — |
| Research Site | San Diego | California | 92123 | — |
| Research Site | San Francisco | California | 94118 | — |
| Research Site | San Francisco | California | 94143 | — |
| Research Site | Gainesville | Florida | 32601 | — |
| Research Site | Miami | Florida | 33155 | — |
| Research Site | Park Ridge | Illinois | 60068 | — |
| Research Site | Louisville | Kentucky | 40202 | — |
| Research Site | Portland | Maine | 04102 | — |
| Research Site | Boston | Massachusetts | 02114 | — |
| Research Site | Worcester | Massachusetts | 01655 | — |
| Research Site | Southfield | Michigan | 48075 | — |
| Research Site | Jackson | Mississippi | 39202 | — |
| Research Site | Kansas City | Missouri | 64108 | — |
| Research Site | Las Vegas | Nevada | 89109 | — |
| Research Site | Mays Landing | New Jersey | 08330 | — |
| Research Site | Buffalo | New York | 14222 | — |
| Research Site | New Hyde Park | New York | 11040 | — |
| Research Site | Providence | Rhode Island | 02903 | — |
| Research Site | Nashville | Tennessee | 37232 | — |
| Research Site | Fort Worth | Texas | 76104 | — |
| Research Site | San Antonio | Texas | 78229 | — |
| Research Site | Huntington | West Virginia | 25701 | — |
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 26 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01004185, 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 25, 2012 · Synced Oct 17, 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 NCT01004185 live on ClinicalTrials.gov.