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NCT01532648 · ClinicalTrials.gov registry record · Phase 3
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)
A Phase 3 study of Ulcerative Colitis, sponsored by Bausch Health Americas.
- Completed
- Registry status
- Phase 3
- Development phase
- 510
- Enrollment target
- 20
- Study locations
NCT01532648: Completed Phase 3 study of Ulcerative Colitis, sponsored by Bausch Health Americas.
NCT01532648 is a Phase 3 study of Ulcerative Colitis that has completed, run by Bausch Health Americas. The registered enrollment target is 510 participants, below the 2,053-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (75% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01532648, a Phase 3 study of Ulcerative Colitis, has completed, sponsored by Bausch Health Americas.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 510 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study is to compare the efficacy and safety of budesonide MMX 9 mg versus placebo as add-on therapy to an existing oral 5-ASA regimen for the induction of remission in participants with active mild or moderate ulcerative colitis (UC).
Primary Outcome
Clinical remission defined as a score of 0 for rectal bleeding and 0 for stool frequency components from the Ulcerative Colitis Disease Activity Index (UCDAI). UCDAI is the sum (0 to 12) of 4 severity scores (0 to 3). Stool frequency and rectal bleeding were based on information recorded in daily participant diaries. The diary entries were averaged for rectal bleeding and stool frequency for 3 days prior to (and closest to) Day 56 with non-missing diary data, within 5 days prior to (and closest
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Budesonide MMX®
- DRUG 5-ASA
Study Locations (20)
Florida
- Santarus Clinical Investigational Site 1035 - Boynton Beach
- Santarus Clinical Investigational Site 1045 - Jacksonville
- Santarus Clinical Investigational Site 1001 - Largo
- Santarus Clinical Investigational Site 1024 - Maitland
- Santarus Clinical Investigational Site 1029 - Port Orange
- Santarus Clinical Investigational Site 1010 - Winter Park
- Santarus Clinical Investigational Site 1002 - Zephyrhills
California
- Santarus Clinical Investigational Site 1043 - Anaheim
- Santarus Clinical Investigational Site 1071 - Lakewood
- Santarus Clinical Investigational Site 1003 - San Diego
Illinois
- Santarus Clinical Investigational Site 1075 - Chicago
- Santarus Clinical Investigational Site 1065 - Oak Lawn
Michigan
- Santarus Clinical Investigational Site 1016 - Chesterfield
- Santarus Clinical Investigational Site 1081 - Novi
Colorado
- Santarus Clinical Investigational Site 1063 - Littleton
Connecticut
- Santarus Clinical Investigational Site 1028 - Bristol
Georgia
- Santarus Clinical Investigational Site 1050 - Decatur
Indiana
- Santarus Clinical Investigational Site 1058 - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 510 participants |
| Start Date | 2012-01-27 |
| Est. Completion | 2013-10-02 |
| Phase | Phase 3 |
What the finished NCT01532648 record still lists
NCT01532648 is an interventional study that assigns participants to a tested intervention. The registered 510 participants enrollment target is mid-sized for trials with a published cap, below the 2,053-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (75% lower).
The record links to 1 condition, with Ulcerative Colitis appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT01532648 names 20 study sites across 10 states, led by Florida, California, Illinois.
Frequently Asked Questions
What is clinical trial NCT01532648 about?
NCT01532648 is a clinical study titled "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)". This study is to compare the efficacy and safety of budesonide MMX 9 mg versus placebo as add-on therapy to an existing oral 5-ASA regimen for the induction of remission in participants with active mild or moderate ulcerative colitis (UC).
What is the current status of trial NCT01532648?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 510 participants. The study started on 2012-01-27. Estimated completion is 2013-10-02.
What conditions does trial NCT01532648 study?
This clinical trial studies the following conditions: Ulcerative Colitis.
What interventions are being tested in trial NCT01532648?
The interventions under investigation include: Placebo (DRUG), Budesonide MMX® (DRUG), 5-ASA (DRUG).
Who is sponsoring clinical trial NCT01532648?
This trial is sponsored by Bausch Health Americas, which has 168 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01532648 being conducted?
This trial has 20 study locations across California, Colorado, Connecticut, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01532648's enrollment target sits among peer trials
510 22nd of 122 higher than 101 of 122 other Ulcerative Colitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Ulcerative Colitis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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