Predicting Response to Standardized Pediatric Colitis Therapy
Public ClinicalTrials.gov record NCT01536535. 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
Multicenter Open-label Study Evaluating the Safety and Efficacy of Standardized Initial Therapy Using Either Mesalamine or Corticosteroids Then Mesalamine to Treat Children and Adolescents With Newly Diagnosed Ulcerative Colitis.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a multi-center, open-label study to determine the safety and effectiveness (how well it works) of two standardized treatments called "mesalamine" (Pentasa®) and "prednisone" in children with newly diagnosed Ulcerative Colitis (UC). Standardized treatments are types of treatments agreed upon and used by many qualified doctors. The medications being used in this study are considered "standard of care". Currently the ways in which these medicines are used (doses, frequency of dosing) may vary from site to site. This study will determine response to a standardized way of giving these medicines. This study will also identify biomarkers for ulcerative colitis. Biomarkers are things that doctors can find in blood, stool, or bowel tissue that indicate how much inflammation there is in the bowel, how the inflammation is produced, and whether the inflammation is responding to treatment. Collecting response and remission (free of symptoms) information on these standardized treatments and the "biomarkers" can possibly help doctors create a model, or plan to know which children with UC may respond quickly, or which children may develop complications.
Study identification
- NCT ID
- NCT01536535
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 431 participants
Conditions and interventions
Conditions
Interventions
- Mesalazine Drug
- IV Corticosteroid Drug
- Oral Corticosteroids Drug
- Additional Therapies Other
- Colectomy Procedure
Drug · Other · Procedure
Eligibility (public fields only)
- Age range
- 4 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
- Jul 10, 2012 (Actual)
- Primary completion
- Apr 30, 2018 (Actual)
- Completion
- Apr 30, 2018 (Actual)
- Last update posted
- Sep 20, 2019
2012 – 2018
United States locations
- U.S. sites
- 26
- U.S. states
- 19
- U.S. cities
- 25
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UCLA Medical Center | Los Angeles | California | 90095 | — |
| University of California at San Francisco | San Francisco | California | 94143 | — |
| Connecticut Children's Medical Center | Hartford | Connecticut | 06106 | — |
| Nemours Children's Clinic | Jacksonville | Florida | 32207 | — |
| Emory Children's Center | Atlanta | Georgia | 30322 | — |
| Ann & Robert H. Lurie Children's Hospital of Chicago | Chicago | Illinois | 60611-2605 | — |
| Riley Children's Hospital | Indianapolis | Indiana | 46202 | — |
| John Hopkins Children's Hospital | Baltimore | Maryland | 21287 | — |
| Children's Hospital of Boston | Boston | Massachusetts | 02115 | — |
| University of Minnesota Medical Center | Minneapolis | Minnesota | 55454 | — |
| Goryeb Children's Hospital / Atlantic Health | Morristown | New Jersey | 07962 | — |
| Women and Children's Hospital of Buffalo | Buffalo | New York | 14222 | — |
| Cohen Children's Medical Center | New Hyde Park | New York | 11040 | — |
| Mt Sinai Hospital | New York | New York | 10029 | — |
| Morgan Stanley Children's Hospital | New York | New York | 10032 | — |
| Golisano Children's Hospital SUNY Upstate Medical University | Syracuse | New York | 13210 | — |
| University of North Carolina at Chapel HIll | Chapel Hill | North Carolina | 27599 | — |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | — |
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | — |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | — |
| Children's Hospital of Pittsburgh of UPMC | Pittsburgh | Pennsylvania | 15224 | — |
| Hasbro Children's Hospital | Providence | Rhode Island | 02903 | — |
| Monroe Carell Jr. Children's Hospital at Vanderbilt | Nashville | Tennessee | 37232 | — |
| UT Southwestern | Dallas | Texas | 75235 | — |
| Primary Children's Medical Center (University of Utah) | Salt Lake City | Utah | 84132 | — |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | — |
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 NCT01536535, 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 Sep 20, 2019 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01536535 live on ClinicalTrials.gov.