Ability to Maintain or Achieve Clinical and Endoscopic Remission With MMX Mesalamine Once Daily in Adults With Ulcerative Colitis
Public ClinicalTrials.gov record NCT01124149. 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
A Phase 4, Open-label, Multicenter, Prospective Study to Evaluate the Effect of Remission Status on the Ability to Maintain or Achieve Clinical and Endoscopic Remission During a 12-Month, Long-term Maintenance Phase With 2.4g/Day MMX Mesalamine/Mesalazine Once Daily in Adult Subjects With Ulcerative Colitis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study was designed to evaluate if subjects who achieve complete remission after 8 weeks of acute therapy with MMX mesalamine/mesalazine 4.8g/day given QD have better long-term outcomes and remain in remission longer compared with subjects who demonstrate only partial remission after acute therapy with MMX mesalamine/mesalazine 4.8g/day given QD. Therefore, subjects who achieve either complete or partial remission will enter into a 12-month maintenance phase, during which they will receive MMX mesalamine/mesalazine 2.4g/day given QD. Remission status for the 2 groups will be evaluated and compared at the end of this 12-month maintenance period. The data obtained from this study will provide scientifically meaningful information to demonstrate that achieving complete remission (clinical and endoscopic remission) is important for a better long-term prognosis, or that the current paradigm of symptomatic treatment is appropriate.
Study identification
- NCT ID
- NCT01124149
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 759 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
- Jun 29, 2010 (Actual)
- Primary completion
- Dec 7, 2012 (Actual)
- Completion
- Dec 7, 2012 (Actual)
- Last update posted
- Jun 9, 2021
2010 – 2012
United States locations
- U.S. sites
- 34
- U.S. states
- 21
- U.S. cities
- 33
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Birmingham Gastroenterology Associates, PC | Birmingham | Alabama | 35209 | — |
| Advanced Clinical Research Institute | Anaheim | California | 92801 | — |
| Digestive & Liver Disease Specialists | Garden Grove | California | 92840 | — |
| Long Beach VA Medical Center | Long Beach | California | 90822 | — |
| Clinical Applications Laboratories, Inc. | San Diego | California | 92103 | — |
| Conneticut Gastroenterolgy Institute | Bristol | Connecticut | 06010 | — |
| Borland-Groover Clinic | Jacksonville | Florida | 32256 | — |
| United Medical Research | New Smyrna Beach | Florida | 32168 | — |
| Advances Gastroenterology Associates | Palm Harbor | Florida | 34684 | — |
| Atlanta Gastroenterology Associates, LLC | Atlanta | Georgia | 30342 | — |
| Atlanta Gastroenterology Associates | Marietta | Georgia | 30067 | — |
| University of Chicago Medical Center | Chicago | Illinois | 60637 | — |
| Midwest Clinical Research Associates | Moline | Illinois | 61265 | — |
| Gastrointestinal Clinic of Quad Cities | Davenport | Iowa | 52807 | — |
| New Orleans Research Institute | Metairie | Louisiana | 70006 | — |
| Delta Research Partners | Monroe | Louisiana | 71201 | — |
| Louisiana Research Center, LLC | Shreveport | Louisiana | 71103 | — |
| Digestive Disorders Associates | Annapolis | Maryland | 21401 | — |
| Digestive Disease Associates | Baltimore | Maryland | 21229 | — |
| Center for Digestive Health | Troy | Michigan | 48098 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| Center for Digestive & Liver Disease, Inc. | Mexico | Missouri | 65265 | — |
| Long Island Clinical Research Associates, LLP | Great Neck | New York | 11021 | — |
| Gastrointestinal Research Associates | Setauket | New York | 11733 | — |
| LeBauer Research Associates | Greensboro | North Carolina | 27402 | — |
| Ohio Gastroenterolgy and Liver Intstitute | Cincinnati | Ohio | 45219 | — |
| Regional Gastroenterology Associates of Lancaster, Ltd. | Lancaster | Pennsylvania | 17604 | — |
| Gastroenterology Associates, LLC | Kingsport | Tennessee | 37660 | — |
| S.D. Khan | Houston | Texas | 77090 | — |
| Gastroenterology Clinic of San Antonio, PA | San Antonio | Texas | 78229 | — |
| Colon and Rectal Disease Center | Sandy City | Utah | 84070 | — |
| Physicians Research Option, LLC | Sandy City | Utah | 84094 | — |
| Alexandria Clinical Research | Alexandria | Virginia | 22304 | — |
| Wisconsin Center for Advances Research | Milwaukee | Wisconsin | 53215 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 71 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01124149, 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 Jun 9, 2021 · Synced Oct 17, 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 NCT01124149 live on ClinicalTrials.gov.