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NCT00801723 · ClinicalTrials.gov registry record · Phase 3
(CB-01-02/04) Extension Study of Budesonide Multi-Matrix System (MMX) 6 mg in Maintenance Of Remission In Patients With Ulcerative Colitis.
A Phase 3 study of Ulcerative Colitis, sponsored by Bausch Health Americas.
- Completed
- Registry status
- Phase 3
- Development phase
- 123
- Enrollment target
- 20
- Study locations
NCT00801723 is a Phase 3 study of Ulcerative Colitis that has completed, run by Bausch Health Americas. The registered enrollment target is 123 participants, below the 2,056-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (94% lower). The trial reports 20 study locations across 8 states.
The verdict
NCT00801723, a Phase 3 study of Ulcerative Colitis, has completed, sponsored by Bausch Health Americas.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 123 participants
- Enrollment target
- 20
- Study locations
Study Summary
Randomized, double-blind, comparative study versus placebo performed in patients from studies CB-01-02/01 (NCT00679432), CB-01-02/02 (NCT00679380), or CB-01-02/06 (NCT01100112) who achieved ulcerative colitis disease activity index (UCDAI) remission after 8 weeks of treatment. Patients in remission at the End of Study visit will be given the opportunity to enter the 12-month Maintenance Phase study outlined in this protocol (CB-01-02/04). The End of Study visit in studies 01, 02, and 06 will be set as the Visit 1 (Day 0) of this study. There will be no interruption of study treatment between the parent studies and this study. It is planned that approximately 150 patients will be enrolled in the study. Patients will be randomly assigned to two groups to receive either budesonide MMX 6 mg or placebo irrespective of the treatment assigned in studies 01, 02, or 06. Treatments will be administered once a day after breakfast for a maximum of 12 months or up to the occurrence of the first clinical relapse, where clinical relapse is defined as combined recurrence of rectal bleeding and stool frequency ≥ 1-2 stools/day above normal for the patient (score ≥ 1 in both UCDAI items). During the study, patients will be assessed for safety and efficacy at Visit 1 and after 1, 3, 6, 9, and 12 months of treatment. Patients will be contacted by telephone on a monthly basis for safety assessment. In case of occurrence of symptoms suggestive of clinical relapse, patients will attend an unscheduled visit at any time during the study.
Conditions Studied
Interventions
- DRUG Placebo Tablet
- DRUG Budesonide MMX 6 mg Tablet
Study Locations (20)
Florida
- Santarus Clinical Investigational Site 5089 - Boynton Beach
- Santarus Clinical Investigational Site 5041 - Hollywood
- Santarus Clinical Investigational Site 5055 - New Smyrna Beach
- Santarus Clinical Investigational Site 5074 - Port Orange
- Santarus Clinical Investigational Site 5032 - Tampa
- Santarus Clinical Investigational Site 5009 - Tampa
- Santarus Clinical Investigational Site 5047 - Winter Park
- Santarus Clinical Investigational Site 5003 - Zephyrhills
California
- Santarus Clinical Investigational Site 5044 - Anaheim
- Santarus Clinical Investigational Site 5087 - Lakewood
- Santarus Clinical Investigational Site 5033 - Los Angeles
- Santarus Clinical Investigational Site 5070 - Palm Springs
- Santarus Clinical Investigational Site 5067 - San Diego
Georgia
- Santarus Clinical Investigational Site 5016 - Atlanta
- Santarus Clinical Investigational Site 5056 - Columbus
Alabama
- Santarus Clinical Investigational Site 5051 - Huntsville
Arizona
- Santarus Clinical Investigational Site 5088 - Tucson
Colorado
- Santarus Clinical Investigational Site 5064 - Lakewood
Illinois
- Santarus Clinical Investigational Site 5068 - Evanston
Louisiana
- Santarus Clinical Investigational Site 5008 - Metairie
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 123 participants |
| Start Date | 2008-12 |
| Est. Completion | 2011-06 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00801723
The ClinicalTrials.gov registry entry for NCT00801723 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 123 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,056-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (94% lower). The listed sponsor is Bausch Health Americas, which has 168 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Ulcerative Colitis appearing as the primary indexed condition, and to 2 interventions - of which Placebo Tablet is the first listed.
NCT00801723 reports 20 study locations spanning 8 distinct geographic areas - top geographies include Florida, California, Georgia.
Frequently Asked Questions
What is clinical trial NCT00801723 about?
NCT00801723 is a clinical study titled "(CB-01-02/04) Extension Study of Budesonide Multi-Matrix System (MMX) 6 mg in Maintenance Of Remission In Patients With Ulcerative Colitis.". Randomized, double-blind, comparative study versus placebo performed in patients from studies CB-01-02/01 (NCT00679432), CB-01-02/02 (NCT00679380), or CB-01-02/06 (NCT01100112) who achieved ulcerative colitis disease activity index (UCDAI) remission after 8 weeks of treatment. Patients in remission...
What is the current status of trial NCT00801723?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 123 participants. The study started on 2008-12. Estimated completion is 2011-06.
What conditions does trial NCT00801723 study?
This clinical trial studies the following conditions: Ulcerative Colitis.
What interventions are being tested in trial NCT00801723?
The interventions under investigation include: Placebo Tablet (DRUG), Budesonide MMX 6 mg Tablet (DRUG).
Who is sponsoring clinical trial NCT00801723?
This trial is sponsored by Bausch Health Americas, which has 168 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00801723 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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