Trial · NCT00679432

(CB-01-02/01) Randomized Placebo Controlled Trial of Budesonide-multi-matrix System (MMX™) 6 mg and 9 mg in Patients With Ulcerative Colitis

NCT00679432, Phase 3, Completed, Bausch Health Americas, Inc.; results first posted 2014-08-01

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. (CB-01-02/01) Randomized Placebo Controlled Trial of Budesonide-multi-matrix System (MMX™) 6 mg and 9 mg in Patients With Ulcerative Colitis. Trials, record NCT00679432. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00679432

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: (CB-01-02/01) Randomized Placebo Controlled Trial of Budesonide-multi-matrix System (MMX™) 6 mg and 9 mg in Patients With Ulcerative Colitis
NCT number: NCT00679432
Status: Completed
Phases: Phase 3
Enrollment: 510 participants, actual
Lead sponsor: Bausch Health Americas, Inc.
Conditions: Ulcerative Colitis
Interventions: Blood sampling, endoscopy, budesonide-MMX® 6 mg, budesonide-MMX® 9 mg, Placebo, Asacol® 400 mg
First posted: 2008-05-16
Last updated: 2019-12-10
Results first posted: 2014-08-01

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Clinical and Endoscopic Remission.	8 weeks	Clinical and endoscopic remission defined as a Ulcerative Colitis Disease Activity Index (UCDAI) score ≤ 1, with subscores of 0 for rectal bleeding, stool frequency, and mucosal appearance and with a ≥ 1 point reduction in the endoscopic index score.
Secondary	Clinical Improvement.	8 weeks	Clinical improvement, defined as a ≥ 3-point improvement in UCDAI from baseline to the end of Week 8.
Secondary	Endoscopic Improvement	8 weeks	Greater or equal to a 1 point improvement in the mucosal appearance subscore of the UCDAI, from baseline to week 8. As per the hierarchical testing procedure for secondary endpoints, because clinical improvement was not statistically significant in the ITT population, formal statistical comparisons for endoscopic improvement between the 2 budesonide MMX groups and placebo were not conducted.

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Clinical and Endoscopic Remission.	8 weeks	Intent-to-Treat (ITT) population= primary population for efficacy/baseline characteristics analyses. ITT population= randomized patients who received study drug, and did not include patients with major entry criteria/GCP violations or normal histology at baseline (N= 509 randomized - 3\[infectious colitis\] - 17\[normal histology at baseline\] = 489).	percentage of patients	NUMBER
SECONDARY	Clinical Improvement.	8 weeks	Intent-to-Treat (ITT) population= primary population for efficacy/baseline characteristics analyses. ITT population= randomized patients who received study drug, and did not include patients with major entry criteria/GCP violations or normal histology at baseline (N= 509 randomized - 3\[infectious colitis\] - 17\[normal histology at baseline\] = 489).	percentage of patients	NUMBER
SECONDARY	Endoscopic Improvement	8 weeks	Intent-to-Treat (ITT) population= primary population for efficacy/baseline characteristics analyses. ITT population= randomized patients who received study drug, and did not include patients with major entry criteria/GCP violations or normal histology at baseline (N= 509 randomized - 3\[infectious colitis\] - 17\[normal histology at baseline\] = 489).	percentage of patients	NUMBER

Source ClinicalTrials.gov

Results by group12

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Clinical and Endoscopic Remission.	1: Budesonide-MMX® 6 mg	13.2	95% Confidence Interval 7.2 to 19.3	percentage of patients
Clinical and Endoscopic Remission.	2: Budesonide-MMX® 9 mg	17.9	95% Confidence Interval 11.1 to 24.7	percentage of patients
Clinical and Endoscopic Remission.	3: Placebo	7.4	95% Confidence Interval 2.8 to 12.1	percentage of patients
Clinical and Endoscopic Remission.	4: Asacol® 400 mg	12.1	95% Confidence Interval 6.4 to 17.8	percentage of patients
Clinical Improvement.	1: Budesonide-MMX® 6 mg	30.6	95% Confidence Interval 22.4 to 38.8	percentage of patients
Clinical Improvement.	2: Budesonide-MMX® 9 mg	33.3	95% Confidence Interval 25.0 to 41.7	percentage of patients
Clinical Improvement.	3: Placebo	24.8	95% Confidence Interval 17.1 to 32.5	percentage of patients
Clinical Improvement.	4: Asacol® 400 mg	33.9	95% Confidence Interval 25.5 to 42.2	percentage of patients
Endoscopic Improvement	1: Budesonide-MMX® 6 mg	35.5	95% Confidence Interval 27 to 44.1	percentage of patients
Endoscopic Improvement	2: Budesonide-MMX® 9 mg	41.5	95% Confidence Interval 32.8 to 50.2	percentage of patients

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	1: Budesonide-MMX® 6 mg	126
Overall Study	STARTED	2: Budesonide-MMX® 9 mg	127
Overall Study	STARTED	3: Placebo	129
Overall Study	STARTED	4: Asacol® 400 mg	127
Overall Study	COMPLETED	1: Budesonide-MMX® 6 mg	89
Overall Study	COMPLETED	2: Budesonide-MMX® 9 mg	89
Overall Study	COMPLETED	3: Placebo	76
Overall Study	COMPLETED	4: Asacol® 400 mg	95
Overall Study	NOT COMPLETED	1: Budesonide-MMX® 6 mg	37
Overall Study	NOT COMPLETED	2: Budesonide-MMX® 9 mg	38

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events180

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Anaemia	Blood and lymphatic system disorders	1: Budesonide-MMX® 6 mg	1	126	1
other	Anaemia	Blood and lymphatic system disorders	2: Budesonide-MMX® 9 mg	0	127	0
other	Anaemia	Blood and lymphatic system disorders	3: Placebo	4	129	4
other	Anaemia	Blood and lymphatic system disorders	4: Asacol® 400 mg	2	127	2
other	Abdominal distension	Gastrointestinal disorders	1: Budesonide-MMX® 6 mg	2	126	3
other	Abdominal distension	Gastrointestinal disorders	2: Budesonide-MMX® 9 mg	4	127	6
other	Abdominal distension	Gastrointestinal disorders	3: Placebo	2	129	2
other	Abdominal distension	Gastrointestinal disorders	4: Asacol® 400 mg	4	127	4
other	Abdominal pain	Gastrointestinal disorders	1: Budesonide-MMX® 6 mg	2	126	3
other	Abdominal pain	Gastrointestinal disorders	2: Budesonide-MMX® 9 mg	6	127	7

1 to 10 of 180Source ClinicalTrials.gov

See all 180 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	1: Budesonide-MMX® 6 mg
Total, all-cause mortality	2: Budesonide-MMX® 9 mg
Total, all-cause mortality	3: Placebo
Total, all-cause mortality	4: Asacol® 400 mg
Total, other adverse events	1: Budesonide-MMX® 6 mg	35	126
Total, other adverse events	2: Budesonide-MMX® 9 mg	36	127
Total, other adverse events	3: Placebo	34	129
Total, other adverse events	4: Asacol® 400 mg	31	127
Total, serious adverse events	1: Budesonide-MMX® 6 mg	2	126
Total, serious adverse events	2: Budesonide-MMX® 9 mg	3	127

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
22892337	RESULT

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00679432

GET https://conductscience.org/api/trials/v1/NCT00679432/events?page=2

API reference For AI assistants