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NCT01536535 · ClinicalTrials.gov registry record · Phase 4
Predicting Response to Standardized Pediatric Colitis Therapy
A Phase 4 study, sponsored by Connecticut Children's Medical Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 431
- Enrollment target
NCT01536535 is a Phase 4 study that has completed, run by Connecticut Children's Medical Center. The registered enrollment target is 431 participants.
The verdict
NCT01536535, a Phase 4 study, has completed, sponsored by Connecticut Children's Medical Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 431 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG Oral Corticosteroids
- DRUG Mesalazine
- DRUG IV Corticosteroid
- OTHER Additional Therapies
- PROCEDURE Colectomy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 431 participants |
| Start Date | 2012-07-10 |
| Est. Completion | 2018-04-30 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01536535
The ClinicalTrials.gov registry entry for NCT01536535 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 431 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Connecticut Children's Medical Center, which has 55 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Oral Corticosteroids is the first listed.
NCT01536535 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01536535 about?
NCT01536535 is a clinical study titled "Predicting Response to Standardized Pediatric Colitis Therapy". 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 ...
What is the current status of trial NCT01536535?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 431 participants. The study started on 2012-07-10. Estimated completion is 2018-04-30.
What interventions are being tested in trial NCT01536535?
The interventions under investigation include: Oral Corticosteroids (DRUG), Mesalazine (DRUG), IV Corticosteroid (DRUG), Additional Therapies (OTHER), Colectomy (PROCEDURE).
Who is sponsoring clinical trial NCT01536535?
This trial is sponsored by Connecticut Children's Medical Center, which has 55 total clinical trials registered on ClinicalTrials.gov.
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