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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: Completed Phase 4 study, sponsored by Connecticut Children's Medical Center.
NCT01536535 is a Phase 4 study that has completed, run by Connecticut Children's Medical Center. The registered enrollment target is 431 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (17% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Week 52 CS-free remission: Number of participants with a PUCAI \< 10 and no corticosteroids (CS) for 28 days without additional therapy or colectomy. Participants in both groups received corticosteroids, biologics, or colectomies, if symptomatic. The Pediatric Ulcerative Colitis Activity Index (PUCAI) is a non-invasive disease activity index. The index measures include abdominal pain, rectal bleeding, stool consistency, number of stools per 24 hours, nocturnal stools, and activity level. A tota
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 |
What the finished NCT01536535 record still lists
NCT01536535 is an interventional study that assigns participants to a tested intervention. The registered 431 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (17% lower).
The record links to 0 conditions, and to 5 interventions - of which Oral Corticosteroids is the first listed.
NCT01536535 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01536535's enrollment target sits among peer trials
431 194th of 2000 higher than 1,807 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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