ClinicalTrials.gov record
(CB-01-02/01) Randomized Placebo Controlled Trial of Budesonide-multi-matrix System (MMX™) 6 mg and 9 mg in Patients With Ulcerative Colitis
ClinicalTrials.gov ID: NCT00679432
Public ClinicalTrials.gov record NCT00679432. 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
Efficacy and Safety of New Oral Budesonide-MMX™ (CB-01-02) 6 mg and 9 mg Extended Release Tablet Formulations in Patients With Mild or Moderate, Active Ulcerative Colitis. A Multicenter, Randomized, Double-blind, Double Dummy Comparative Study Versus Placebo, With an Additional Reference Arm Evaluating Asacol® 2400 mg.
Study identification
- NCT ID
- NCT00679432
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Bausch Health Americas, Inc.
- Industry
- Enrollment
- 510 participants
Conditions and interventions
Conditions
Interventions
- Blood sampling, endoscopy Procedure
- budesonide-MMX® 6 mg Drug
- budesonide-MMX® 9 mg Drug
- Placebo Drug
- Asacol® 400 mg Drug
Procedure · 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
- May 31, 2008
- Primary completion
- Apr 30, 2010
- Completion
- May 31, 2010
- Last update posted
- Dec 9, 2019
2008 – 2010
United States locations
- U.S. sites
- 76
- U.S. states
- 23
- U.S. cities
- 70
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Santarus Clinical Investigational Site 5051 | Huntsville | Alabama | 35801 | — |
| Santarus Clinical Investigational Site 5102 | Mobile | Alabama | 36606 | — |
| Santarus Clinical Investigational Site 5014 | Sylacauga | Alabama | 35150 | — |
| Santarus Clinical Investigational Site 5088 | Tucson | Arizona | 85712 | — |
| Santarus Clinical Investigational Site 5044 | Anaheim | California | 92801 | — |
| Santarus Clinical Investigational Site 5099 | Encinitas | California | 92024 | — |
| Santarus Clinical Investigational Site 5075 | Fremont | California | 94536 | — |
| Santarus Clinical Investigational Site 5087 | Lakewood | California | 90712 | — |
| Santarus Clinical Investigational Site 5033 | Los Angeles | California | 90045 | — |
| Santarus Clinical Investigational Site 5070 | Palm Springs | California | 92262 | — |
| Santarus Clinical Investigational Site 5067 | San Diego | California | 92101 | — |
| Santarus Clinical Investigational Site 5028 | San Francisco | California | 94117 | — |
| Santarus Clinical Investigational Site 5089 | Boynton Beach | Florida | 33426 | — |
| Santarus Clinical Investigational Site 5041 | Hollywood | Florida | 33021 | — |
| Santarus Clinical Investigational Site 5055 | New Smyrna Beach | Florida | 32168 | — |
| Santarus Clinical Investigational Site 5074 | Port Orange | Florida | 32127 | — |
| Santarus Clinical Investigational Site 5032 | Tampa | Florida | 33607 | — |
| Santarus Clinical Investigational Site 5009 | Tampa | Florida | 33613 | — |
| Santarus Clinical Investigational Site 5110 | West Palm Beach | Florida | 33409 | — |
| Santarus Clinical Investigational Site 5047 | Winter Park | Florida | 32789 | — |
| Santarus Clinical Investigational Site 5003 | Zephyrhills | Florida | 33542 | — |
| Santarus Clinical Investigational Site 5016 | Atlanta | Georgia | 30312 | — |
| Santarus Clinical Investigational Site 5056 | Columbus | Georgia | 31904 | — |
| Santarus Clinical Investigational Site 5103 | Savannah | Georgia | 31406 | — |
| Santarus Clinical Investigational Site 5085 | Addison | Illinois | 60101 | — |
| Santarus Clinical Investigational Site 5068 | Evanston | Illinois | 60201 | — |
| Santarus Clinical Investigational Site 5086 | Bloomington | Indiana | 47403 | — |
| Santarus Clinical Investigational Site 5053 | Clive | Iowa | 50325 | — |
| Santarus Clinical Investigational Site 5008 | Metairie | Louisiana | 70006 | — |
| Santarus Clinical Investigational Site 5090 | Annapolis | Maryland | 21401 | — |
| Santarus Clinical Investigational Site 5025 | Baltimore | Maryland | 21229 | — |
| Santarus Clinical Investigational Site 5092 | Hollywood | Maryland | 20636 | — |
| Santarus Clinical Investigational Site 5077 | Prince Frederick | Maryland | 20678 | — |
| Santarus Clinical Investigational Site 5046 | Boston | Massachusetts | 02114 | — |
| Santarus Clinical Investigational Site 5115 | Brockton | Massachusetts | 02301 | — |
| Santarus Clinical Investigational Site 5010 | Chesterfield | Michigan | 48047 | — |
| Santarus Clinical Investigational Site 5006 | Troy | Michigan | 48098 | — |
| Santarus Clinical Investigational Site 5004 | Wyoming | Michigan | 49519 | — |
| Santarus Clinical Investigational Site 5105 | St Louis | Missouri | 63128 | — |
| Santarus Clinical Investigational Site 5094 | Egg Harbor | New Jersey | 08234 | — |
| Santarus Clinical Investigational Site 5005 | Marlton | New Jersey | 08053 | — |
| Santarus Clinical Investigational Site 5024 | Vineland | New Jersey | 08360 | — |
| Santarus Clinical Investigational Site 5011 | Great Neck | New York | 11021 | — |
| Santarus Clinical Investigational Site 5101 | New York | New York | 10016 | — |
| Santarus Clinical Investigational Site 5020 | Pittsford | New York | 14534 | — |
| Santarus Clinical Investigational Site 5096 | Fayetteville | North Carolina | 28304 | — |
| Santarus Clinical Investigational Site 5058 | Huntersville | North Carolina | 28078 | — |
| Santarus Clinical Investigational Site 5091 | New Bern | North Carolina | 28562 | — |
| Santarus Clinical Investigational Site 5124 | Wilmington | North Carolina | 28403 | — |
| Santarus Clinical Investigational Site 5118 | Canton | Ohio | 44701 | — |
| Santarus Clinical Investigational Site 5045 | Cincinnati | Ohio | 45218 | — |
| Santarus Clinical Investigational Site 5078 | Dayton | Ohio | 45440 | — |
| Santarus Clinical Investigational Site 5120 | Mentor | Ohio | 44060 | — |
| Santarus Clinical Investigational Site 5066 | Duncansville | Pennsylvania | 16635 | — |
| Santarus Clinical Investigational Site 5065 | Pottstown | Pennsylvania | 19464 | — |
| Santarus Clinical Investigational Site 5035 | Sayre | Pennsylvania | 18840 | — |
| Santarus Clinical Investigational Site 5107 | Sioux Falls | South Dakota | 57105 | — |
| Santarus Clinical Investigational Site 5130 | Jackson | Tennessee | 38305 | — |
| Santarus Clinical Investigational Site 5095 | Kingsport | Tennessee | 37660 | — |
| Santarus Clinical Investigational Site 5021 | Austin | Texas | 78745 | — |
| Santarus Clinical Investigational Site 5076 | Houston | Texas | 77034 | — |
| Santarus Clinical Investigational Site 5108 | Houston | Texas | 77079 | — |
| Santarus Clinical Investigational Site 5019 | Houston | Texas | 77090 | — |
| Santarus Clinical Investigational Site 5036 | Houston | Texas | 77090 | — |
| Santarus Clinical Investigational Site 5063 | Irving | Texas | 75061 | — |
| Santarus Clinical Investigational Site 5072 | Kingwood | Texas | 77339 | — |
| Santarus Clinical Investigational Site 5054 | La Porte | Texas | 77571 | — |
| Santarus Clinical Investigational Site 5030 | Lewisville | Texas | 75057 | — |
| Santarus Clinical Investigational Site 5093 | Plano | Texas | 75075 | — |
| Santarus Clinical Investigational Site 5049 | San Antonio | Texas | 78229 | — |
| Santarus Clinical Investigational Site 5100 | San Antonio | Texas | 78229 | — |
| Santarus Clinical Investigational Site 5079 | San Antonio | Texas | 78258 | — |
| Santarus Clinical Investigational Site 5098 | Tomball | Texas | 77375 | — |
| Santarus Clinical Investigational Site 5015 | Salt Lake City | Utah | 84107 | — |
| Santarus Clinical Investigational Site 5097 | Christiansburg | Virginia | 24073 | — |
| Santarus Clinical Investigational Site 5119 | Norfolk | Virginia | 23502 | — |
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 29 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00679432, 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 Dec 9, 2019 · Synced Jul 22, 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 protocol, eligibility criteria, and contact information for NCT00679432 live on ClinicalTrials.gov.