Trial · NCT01008410

Efficacy and Safety of Budesonide Foam for Participants With Active Mild to Moderate Ulcerative Proctitis or Proctosigmoiditis

NCT01008410, Phase 3, Completed, Bausch Health Americas, Inc.; results first posted 2019-08-14

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Efficacy and Safety of Budesonide Foam for Participants With Active Mild to Moderate Ulcerative Proctitis or Proctosigmoiditis. Trials, record NCT01008410. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01008410

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Trial

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

Title: Efficacy and Safety of Budesonide Foam for Participants With Active Mild to Moderate Ulcerative Proctitis or Proctosigmoiditis
NCT number: NCT01008410
Status: Completed
Phases: Phase 3
Enrollment: 265 participants, actual
Lead sponsor: Bausch Health Americas, Inc.
Conditions: Proctitis, Proctosigmoiditis
Interventions: Budesonide, Placebo
First posted: 2009-11-05
Last updated: 2019-08-14
Results first posted: 2019-08-14

Source ClinicalTrials.gov

Registered outcomes10

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

List	Outcome	Time frame	Description
Primary	Percentage of Participants Who Achieved Remission	Week 6	Remission was a combined assessment of clinical and endoscopic variables, defined as an endoscopy score of less than or equal to (\<=) 1, a rectal bleeding score of 0, and an improvement or no change from baseline in stool frequency subscales of the Modified Mayo Disease Activity Index (MMDAI) at the end of 6 weeks of treatment. MMDAI was used to assess the overall disease activity for each participant. MMDAI evaluated 4 indices: stool frequency, rectal bleeding, physician's global assessment (PGA) and endoscopy findings each on a scale of 0 to 3 with a maximum total score of 12. Stool frequency MMDAI subscore ranged from 0-3, where 0 indicated normal number of stools per day and 3 indicated 5 or more stools than normal. Rectal bleeding MMDAI subscore ranged from 0-3, where 0 indicated no blood seen and 3 indicated blood alone passed. Endoscopy MMDAI subscore ranged from 0-3, where 0 indicated normal or inactive disease and 3 indicated severe disease (spontaneous bleeding, ulceration).
Secondary	Percentage of Participants Who Achieved a Rectal Bleeding MMDAI Subscale Score of 0 at End of Week 6	Week 6	The MMDAI was used to assess the overall disease activity for each participant. The MMDAI evaluated 4 indices:stool frequency, rectal bleeding, physician's global assessment and endoscopy findings each on a scale of 0 to 3 with a maximum total score of 12. Rectal bleeding MMDAI subscore ranged from 0-3, where 0 indicated no blood seen and 3 indicated blood alone passed. Missing data was imputed using LOCF method.
Secondary	Number of Scheduled Assessments With Rectal Bleeding Responder Classification	Weeks 1, 2, 4, and 6	The MMDAI was used to assess the overall disease activity for each participant. The MMDAI evaluated 4 indices: stool frequency, rectal bleeding, physician's global assessment and endoscopy findings each on a scale of 0 to 3 with a maximum total score of 12. Rectal bleeding MMDAI subscore ranged from 0-3, where 0 indicated no blood seen and 3 indicated blood alone passed. Percentage of participants who were rectal bleeding responder at scheduled assessments were reported. Rectal bleeding responders were defined as those participants who achieved a rectal bleeding MMDAI subscale score of 0 during the treatment period. Missing data was imputed using LOCF method.
Secondary	Percentage of Participants Who Achieved an Endoscopy MMDAI Subscale Score of 0 or 1 at End of Week 6	Week 6	The MMDAI was used to assess the overall disease activity for each participant. The MMDAI evaluated 4 indices: stool frequency, rectal bleeding, physician's global assessment and endoscopy findings each on a scale of 0 to 3 with a maximum total score of 12. Endoscopy subscale ranged from 0-3, where 0 = normal or inactive disease, 1 = mild disease, 2 = moderate disease and 3 = severe disease (spontaneous bleeding, ulceration). Percentage of participants with normal or mild disease have been presented in this outcome measure. Missing data was imputed using LOCF method.
Secondary	Percentage of Participants Who Achieved a Score of 0 for Rectal Bleeding Subscale and a Combined Score of <=2 for Bowel Frequency and Physician's Global Assessment (PGA) in the MMDAI Subscales at End of Week 6	Week 6	The MMDAI was used to assess the overall disease activity for each participant. The MMDAI evaluated 4 indices: stool frequency, rectal bleeding, PGA and endoscopy findings each on a scale of 0 to 3 with a maximum total score of 12. Rectal bleeding subscore ranged from 0-3, where 0 indicated no blood seen and 3 indicated blood alone passed. Bowel frequency (BF) subscore ranged from 0-3, where 0 indicated normal number of stools per day and 3 indicated 5 or more stools than normal. PGA subscore ranged from 0-3, where 0 indicated normal disease and 3 indicated severe disease. Missing data was imputed using LOCF method.
Secondary	Percentage of Participants Who Achieved an MMDAI Total Score of <= 3 With Greater Than or Equal to (>=2) Points of Improvement From Baseline at the End of Week 6	Week 6	The MMDAI was used to assess the overall disease activity for each participant. The MMDAI evaluated 4 indices: stool frequency, rectal bleeding, physician's global assessment and endoscopy findings each on a scale of 0 to 3 with a maximum total score of 12. Rectal bleeding subscore ranged from 0-3, where 0 indicated no blood seen and 3 indicated blood alone passed. BF subscore ranged from 0-3, where 0 indicated normal number of stools per day and 3 indicated 5 or more stools than normal. Physician global assessment (PGA) subscore ranged from 0-3, where 0 indicated normal and 3 indicated severe disease. Endoscopy subscore ranged from 0-3, where 0 indicated normal and 3 indicated severe disease. MMDAI total score ranged from 0-12, where higher score indicated severe disease. Missing data was imputed using LOCF method.
Secondary	Percentage of Participants Who Achieved Improvement of >=1 Point From Baseline in the MMDAI Endoscopy Subscale Score at End of Week 6	Week 6	The MMDAI was used to assess the overall disease activity for each participant. The MMDAI evaluated 4 indices: stool frequency, rectal bleeding, PGA and endoscopy findings each on a scale of 0 to 3 with a maximum total score of 12. Endoscopy subscore ranged from 0-3, where 0 = normal or inactive disease, 1 = mild disease (erythema, decreased vascular pattern), 2 = moderate disease (marked erythema, absent vascular pattern, friability, erosions), and 3 = severe disease (spontaneous bleeding, ulceration). Missing data was imputed using LOCF method.
Secondary	Percentage of Participants Who Achieved Improvement of >=1 Point From Baseline in the MMDAI Rectal Bleeding Subscale Score at End of Week 6	Week 6	The MMDAI was used to assess the overall disease activity for each participant. The MMDAI evaluated 4 indices: stool frequency, rectal bleeding, PGA and endoscopy findings each on a scale of 0 to 3 with a maximum total score of 12. Rectal bleeding MMDAI subscore ranged from 0-3, where 0 = no blood seen, 1 = streaks of blood with stool less than half the time, 2 = obvious blood with stool most of the time, and 3 indicated blood alone passed. Missing data was imputed using LOCF method.
Secondary	Percentage of Participants Who Achieved >=3 Point Improvement From Baseline in the MMDAI Total Score Including Improvement of >=1 Point From Baseline in the MMDAI Rectal Bleeding Subscale Score and MMDAI Endoscopy Subscale at End of Week 6	Week 6	The MMDAI was used to assess the overall disease activity for each participant. The MMDAI evaluated 4 indices: stool frequency, rectal bleeding, PGA and endoscopy findings each on a scale of 0 to 3 with a maximum total score of 12. Rectal bleeding subscore ranged from 0-3, where 0 indicated no blood seen and 3 indicated blood alone passed. BF subscore ranged from 0-3, where 0 indicated normal number of stools per day and 3 indicated 5 or more stools than normal. PGA subscore ranged from 0-3, where 0 indicated normal and 3 indicated severe disease. Endoscopy subscore ranged from 0-3, where 0 indicated normal and 3 indicated severe disease. MMDAI total score ranged from 0-12, where higher score indicated severe disease. Missing data was imputed using LOCF method.
Secondary	Mean Change From Baseline to Week 6 in MMDAI Total Score and Subscale Scores	Baseline, Week 6	The MMDAI was used to assess the overall disease activity for each participant. The MMDAI evaluated 4 indices: stool frequency, rectal bleeding, PGA and endoscopy findings each on a scale of 0 to 3 with a maximum total score of 12. Rectal bleeding subscore ranged from 0-3, where 0 indicated no blood seen and 3 indicated blood alone passed. BF subscore ranged from 0-3, where 0 indicated normal number of stools per day and 3 indicated 5 or more stools than normal. PGA subscore ranged from 0-3, where 0 indicated normal and 3 indicated severe disease. Endoscopy subscore ranged from 0-3, where 0 indicated normal and 3 indicated severe disease. MMDAI total score ranged from 0-12, where higher score indicated severe disease. Missing data was imputed using LOCF method.

Source ClinicalTrials.gov

Outcomes10

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Percentage of Participants Who Achieved Remission	Week 6	ITT population included all randomized participants. Missing data was imputed using last observation carried forward (LOCF) method.	percentage of participants	NUMBER
SECONDARY	Percentage of Participants Who Achieved a Rectal Bleeding MMDAI Subscale Score of 0 at End of Week 6	Week 6	ITT population included all randomized participants.	percentage of participants	NUMBER
SECONDARY	Number of Scheduled Assessments With Rectal Bleeding Responder Classification	Weeks 1, 2, 4, and 6	ITT population included all randomized participants.	percentage of participants	NUMBER
SECONDARY	Percentage of Participants Who Achieved an Endoscopy MMDAI Subscale Score of 0 or 1 at End of Week 6	Week 6	ITT population included all randomized participants.	percentage of participants	NUMBER
SECONDARY	Percentage of Participants Who Achieved a Score of 0 for Rectal Bleeding Subscale and a Combined Score of <=2 for Bowel Frequency and Physician's Global Assessment (PGA) in the MMDAI Subscales at End of Week 6	Week 6	ITT population included all randomized participants.	percentage of participants	NUMBER
SECONDARY	Percentage of Participants Who Achieved an MMDAI Total Score of <= 3 With Greater Than or Equal to (>=2) Points of Improvement From Baseline at the End of Week 6	Week 6	ITT population included all randomized participants.	percentage of participants	NUMBER
SECONDARY	Percentage of Participants Who Achieved Improvement of >=1 Point From Baseline in the MMDAI Endoscopy Subscale Score at End of Week 6	Week 6	ITT population included all randomized participants.	percentage of participants	NUMBER
SECONDARY	Percentage of Participants Who Achieved Improvement of >=1 Point From Baseline in the MMDAI Rectal Bleeding Subscale Score at End of Week 6	Week 6	ITT population included all randomized participants.	percentage of participants	NUMBER
SECONDARY	Percentage of Participants Who Achieved >=3 Point Improvement From Baseline in the MMDAI Total Score Including Improvement of >=1 Point From Baseline in the MMDAI Rectal Bleeding Subscale Score and MMDAI Endoscopy Subscale at End of Week 6	Week 6	ITT population included all randomized participants.	percentage of participants	NUMBER
SECONDARY	Mean Change From Baseline to Week 6 in MMDAI Total Score and Subscale Scores	Baseline, Week 6	ITT population included all randomized participants.	unit on a scale	MEAN

Source ClinicalTrials.gov

Results by group44

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

Outcome	Group	Category	Value	Units
Percentage of Participants Who Achieved Remission	Budesonide		38.3	percentage of participants
Percentage of Participants Who Achieved Remission	Placebo		25.8	percentage of participants
Percentage of Participants Who Achieved a Rectal Bleeding MMDAI Subscale Score of 0 at End of Week 6	Budesonide		46.6	percentage of participants
Percentage of Participants Who Achieved a Rectal Bleeding MMDAI Subscale Score of 0 at End of Week 6	Placebo		28.0	percentage of participants
Number of Scheduled Assessments With Rectal Bleeding Responder Classification	Budesonide	Responder at 1 Assessment	12.0	percentage of participants
Number of Scheduled Assessments With Rectal Bleeding Responder Classification	Placebo	Responder at 1 Assessment	13.6	percentage of participants
Number of Scheduled Assessments With Rectal Bleeding Responder Classification	Budesonide	Responder at 2 Assessment	18.8	percentage of participants
Number of Scheduled Assessments With Rectal Bleeding Responder Classification	Placebo	Responder at 2 Assessment	13.6	percentage of participants
Number of Scheduled Assessments With Rectal Bleeding Responder Classification	Budesonide	Responder at 3 Assessment	21.1	percentage of participants
Number of Scheduled Assessments With Rectal Bleeding Responder Classification	Placebo	Responder at 3 Assessment	10.6	percentage of participants

1 to 10 of 44Source ClinicalTrials.gov

See all 44 results by group

Participant flow8

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Budesonide	133
Overall Study	STARTED	Placebo	132
Overall Study	Received at Least 1 Dose of Study Drug	Budesonide	133
Overall Study	Received at Least 1 Dose of Study Drug	Placebo	132
Overall Study	COMPLETED	Budesonide	108
Overall Study	COMPLETED	Placebo	116
Overall Study	NOT COMPLETED	Budesonide	25
Overall Study	NOT COMPLETED	Placebo	16

Source ClinicalTrials.gov

Adverse events204

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
other	Back pain	Musculoskeletal and connective tissue disorders	Budesonide	1	134
other	Back pain	Musculoskeletal and connective tissue disorders	Placebo	1	131
other	Groin pain	Musculoskeletal and connective tissue disorders	Budesonide	0	134
other	Groin pain	Musculoskeletal and connective tissue disorders	Placebo	1	131
other	Herpes zoster	Infections and infestations	Budesonide	0	134
other	Herpes zoster	Infections and infestations	Placebo	1	131
other	Haemorrhoids	Gastrointestinal disorders	Budesonide	0	134
other	Haemorrhoids	Gastrointestinal disorders	Placebo	2	131
other	Proctitis ulcerative	Gastrointestinal disorders	Budesonide	0	134
other	Proctitis ulcerative	Gastrointestinal disorders	Placebo	4	131

1 to 10 of 204Source ClinicalTrials.gov

See all 204 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Budesonide	0	134
Total, all-cause mortality	Placebo	0	131
Total, other adverse events	Budesonide	66	134
Total, other adverse events	Placebo	47	131
Total, serious adverse events	Budesonide	2	134
Total, serious adverse events	Placebo	3	131

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
25644096	DERIVED	PubMed
27416045	DERIVED	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 comparisons2

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

Comparison	Source
Budesonide vs Placebo: deaths from any cause	Trial comparisons
Budesonide vs Placebo: serious adverse events	Trial comparisons

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.

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Read this trial from software.

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