Dose Escalation and Remission (DEAR)
Public ClinicalTrials.gov record NCT00652145. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Test Treat Strategy to Prevent Ulcerative Colitis Relapse
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00652145
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 119 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 2008 (Type not available)
- Primary completion
- Jan 2013 (Actual)
- Completion
- Jan 2013 (Actual)
- Last update posted
- May 5, 2015
2008 – 2013
United States locations
- U.S. sites
- 8
- U.S. states
- 6
- U.S. cities
- 8
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Gastroenterology Group of Naples | Naples | Florida | 34102 | — |
| Shafran Gastroenterology Center | Winter Park | Florida | 32789 | — |
| Atlanta Gastroenterology Associates | Atlanta | Georgia | 30342 | — |
| University of Maryland Medical Center | Baltimore | Maryland | 21201 | — |
| Chevy Chase Clinical Research | Chevy Chase | Maryland | 20815 | — |
| Minnesota Gastroenterology, P.A. | Plymouth | Minnesota | 55446 | — |
| South Jersey Gastroenterology | Marlton | New Jersey | 08053 | — |
| University of Pennsylvania - Presbyterian Medical Center | Philadelphia | Pennsylvania | 19104 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00652145, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 5, 2015 · Synced Oct 23, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00652145 live on ClinicalTrials.gov.