Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 4 study that has completed, run by James Lewis. The registered enrollment target is 119 participants.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00652145
The ClinicalTrials.gov registry entry for NCT00652145 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 119 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is James Lewis, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which mesalamine is the first listed.
NCT00652145 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.