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NCT00652145 · ClinicalTrials.gov registry record · Phase 4
Dose Escalation and Remission (DEAR)
A Phase 4 study, sponsored by James Lewis.
- Completed
- Registry status
- Phase 4
- Development phase
- 119
- Enrollment target
NCT00652145: Completed Phase 4 study, sponsored by James Lewis.
NCT00652145 is a Phase 4 study that has completed, run by James Lewis. The registered enrollment target is 119 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00652145, a Phase 4 study, has completed, sponsored by James Lewis.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 119 participants
- Enrollment target
Study Summary
The proposed study will test whether increasing Lialda dose can reduce fecal calprotectin (FCP) levels, a marker of intestinal inflammation that is highly predictive of the risk of relapse among patients with quiescent ulcerative colitis. Sixty patients with FCP levels \<50µg/g stool will be observed for 48 weeks. All patients will have FCP concentration measured using a commercially available assay at enrollment, 6 weeks and 12 weeks. All patients with persistently elevated FCP will receive one or both of the following interventions: change in the mesalamine formulation to Lialda and/or increase in the dose of Lialda. Reduction in FCP levels below 50µg/g stool 6 weeks after randomization will be the primary outcome. The proportion of patients achieving this outcome will be compared between groups using Fisher's exact test. All randomized patients as well as those who were excluded from the randomized trial because of a low FCP concentration at baseline will be followed to week 48 to determine the rate of clinical relapse.
Interventions
- DRUG mesalamine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 119 participants |
| Start Date | 2008-09 |
| Est. Completion | 2013-01 |
| Phase | Phase 4 |
What the finished NCT00652145 record still lists
NCT00652145 is an interventional study that assigns participants to a tested intervention. The registered 119 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 (77% lower).
The record links to 0 conditions, and to 1 intervention - of which mesalamine is the first listed.
NCT00652145 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00652145 about?
NCT00652145 is a clinical study titled "Dose Escalation and Remission (DEAR)". The proposed study will test whether increasing Lialda dose can reduce fecal calprotectin (FCP) levels, a marker of intestinal inflammation that is highly predictive of the risk of relapse among patients with quiescent ulcerative colitis. Sixty patients with FCP levels \<50µg/g stool will be observe...
What is the current status of trial NCT00652145?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 119 participants. The study started on 2008-09. Estimated completion is 2013-01.
What interventions are being tested in trial NCT00652145?
The interventions under investigation include: mesalamine (DRUG).
Who is sponsoring clinical trial NCT00652145?
This trial is sponsored by James Lewis, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00652145's enrollment target sits among peer trials
119 712th of 2000 higher than 1,288 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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