Randomized Placebo-Controlled Trial of Budesonide Multi-Matrix System (MMX®) 9 Milligrams (mg) in Participants With Ulcerative Colitis Currently on a 5-Aminosalicylic Acid (5-ASA)
Public ClinicalTrials.gov record NCT01532648. 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 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Budesonide MMX® 9 mg Extended-release Tablets as Add-on Therapy in Patients With Active, Mild or Moderate Ulcerative Colitis Not Adequately Controlled on a Background Oral 5-ASA Regimen
Study identification
- NCT ID
- NCT01532648
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Bausch Health Americas, Inc.
- Industry
- Enrollment
- 510 participants
Conditions and interventions
Conditions
Interventions
- Budesonide MMX® Drug
- Placebo Drug
- 5-ASA Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- 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
- Jan 26, 2012
- Primary completion
- Oct 1, 2013
- Completion
- Oct 1, 2013
- Last update posted
- Sep 5, 2019
2012 – 2013
United States locations
- U.S. sites
- 39
- U.S. states
- 19
- U.S. cities
- 39
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Santarus Clinical Investigational Site 1043 | Anaheim | California | 92801 | — |
| Santarus Clinical Investigational Site 1071 | Lakewood | California | 90712 | — |
| Santarus Clinical Investigational Site 1003 | San Diego | California | 92114 | — |
| Santarus Clinical Investigational Site 1063 | Littleton | Colorado | 80120 | — |
| Santarus Clinical Investigational Site 1028 | Bristol | Connecticut | 06010 | — |
| Santarus Clinical Investigational Site 1035 | Boynton Beach | Florida | 33426 | — |
| Santarus Clinical Investigational Site 1045 | Jacksonville | Florida | 32256 | — |
| Santarus Clinical Investigational Site 1001 | Largo | Florida | 33777 | — |
| Santarus Clinical Investigational Site 1024 | Maitland | Florida | 32751 | — |
| Santarus Clinical Investigational Site 1029 | Port Orange | Florida | 32127 | — |
| Santarus Clinical Investigational Site 1010 | Winter Park | Florida | 32789 | — |
| Santarus Clinical Investigational Site 1002 | Zephyrhills | Florida | 33613 | — |
| Santarus Clinical Investigational Site 1050 | Decatur | Georgia | 30033 | — |
| Santarus Clinical Investigational Site 1075 | Chicago | Illinois | 60637 | — |
| Santarus Clinical Investigational Site 1065 | Oak Lawn | Illinois | 60453 | — |
| Santarus Clinical Investigational Site 1058 | Indianapolis | Indiana | 46202 | — |
| Santarus Clinical Investigational Site 1032 | Shreveport | Louisiana | 71103 | — |
| Santarus Clinical Investigational Site 1044 | Annapolis | Maryland | 21401 | — |
| Santarus Clinical Investigational Site 1016 | Chesterfield | Michigan | 48047 | — |
| Santarus Clinical Investigational Site 1081 | Novi | Michigan | 48377 | — |
| Santarus Clinical Investigational Site 1015 | Wyoming | Michigan | 49159 | — |
| Santarus Clinical Investigational Site 1068 | Ypsilanti | Michigan | 48197 | — |
| Santarus Clinical Investigational Site 1074 | Rochester | Minnesota | 55905 | — |
| Santarus Clinical Investigational Site 1061 | Lebanon | New Hampshire | 03756 | — |
| Santarus Clinical Investigational Site 1021 | Cheektowaga | New York | 14225 | — |
| Santarus Clinical Investigational Site 1072 | Great Neck | New York | 11023 | — |
| Santarus Clinical Investigational Site 1031 | New York | New York | 10028 | — |
| Santarus Clinical Investigational Site 1073 | Wilmington | North Carolina | 28403 | — |
| Santarus Clinical Investigational Site 1080 | Cincinnati | Ohio | 45267 | — |
| Santarus Clinical Investigational Site 1078 | Cleveland | Ohio | 44195 | — |
| Santarus Clinical Investigational Site 1082 | Dayton | Ohio | 45415 | — |
| Santarus Clinical Investigational Site 1064 | Lancaster | Pennsylvania | 17604 | — |
| Santarus Clinical Investigational Site 1006 | Sayre | Pennsylvania | 18840 | — |
| Santarus Clinical Investigational Site 1059 | Austin | Texas | 78705 | — |
| Santarus Clinical Investigational Site 1039 | Houston | Texas | 77030 | — |
| Santarus Clinical Investigational Site 1005 | Pasadena | Texas | 77505 | — |
| Santarus Clinical Investigational Site 1014 | Lancaster | Utah | 84341 | — |
| Santarus Clinical Investigational Site 1038 | Chesapeake | Virginia | 23320 | — |
| Santarus Clinical Investigational Site 1025 | Christiansburg | Virginia | 24073 | — |
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 75 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01532648, 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 Sep 5, 2019 · Synced Jun 25, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01532648 live on ClinicalTrials.gov.