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NCT01130844 · ClinicalTrials.gov registry record · Phase 1
Safety and Pharmacokinetics of MMX Mesalamine in Children and Adolescents With Ulcerative Colitis
A Phase 1 study, sponsored by Shire.
- Completed
- Registry status
- Phase 1
- Development phase
- 52
- Enrollment target
NCT01130844: Completed Phase 1 study, sponsored by Shire.
NCT01130844 is a Phase 1 study that has completed, run by Shire. The registered enrollment target is 52 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01130844, a Phase 1 study, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 52 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the safety and pharmacokinetics of MMX mesalamine following administration in children and adolescents with ulcerative colitis.
Primary Outcome
AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.
Interventions
- DRUG MMX Mesalamine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2010-10-08 |
| Est. Completion | 2013-06-27 |
| Phase | Phase 1 |
What the finished NCT01130844 record still lists
NCT01130844 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% lower).
The record links to 0 conditions, and to 1 intervention - of which MMX Mesalamine is the first listed.
NCT01130844 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01130844 about?
NCT01130844 is a clinical study titled "Safety and Pharmacokinetics of MMX Mesalamine in Children and Adolescents With Ulcerative Colitis". The purpose of this study is to determine the safety and pharmacokinetics of MMX mesalamine following administration in children and adolescents with ulcerative colitis.
What is the current status of trial NCT01130844?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 52 participants. The study started on 2010-10-08. Estimated completion is 2013-06-27.
What interventions are being tested in trial NCT01130844?
The interventions under investigation include: MMX Mesalamine (DRUG).
Who is sponsoring clinical trial NCT01130844?
This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01130844's enrollment target sits among peer trials
52 956th of 2000 higher than 1,032 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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