Trial · NCT01008423
Efficacy and Safety of Budesonide Foam for Participants With Active Mild to Moderate Ulcerative Proctitis or Proctosigmoiditis
NCT01008423, 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 NCT01008423. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01008423
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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
- NCT01008423
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 281 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, 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 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 (BF) 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. 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, 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 | 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 (BF) 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. Here, 'Number analyzed' signifies number of participants evaluable for specified categories. | 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 | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Who Achieved Remission | Budesonide | 44.0 | percentage of participants | ||
| Percentage of Participants Who Achieved Remission | Placebo | 22.4 | percentage of participants | ||
| Percentage of Participants Who Achieved a Rectal Bleeding MMDAI Subscale Score of 0 at End of Week 6 | Budesonide | 50.0 | percentage of participants | ||
| Percentage of Participants Who Achieved a Rectal Bleeding MMDAI Subscale Score of 0 at End of Week 6 | Placebo | 28.6 | percentage of participants | ||
| Number of Scheduled Assessments With Rectal Bleeding Responder Classification | Budesonide | Responder at 1 assessment | 8.2 | percentage of participants | |
| Number of Scheduled Assessments With Rectal Bleeding Responder Classification | Placebo | Responder at 1 assessment | 18.4 | percentage of participants | |
| Number of Scheduled Assessments With Rectal Bleeding Responder Classification | Budesonide | Responder at 2 assessment | 16.4 | percentage of participants | |
| Number of Scheduled Assessments With Rectal Bleeding Responder Classification | Placebo | Responder at 2 assessment | 17.0 | percentage of participants | |
| Number of Scheduled Assessments With Rectal Bleeding Responder Classification | Budesonide | Responder at 3 assessment | 21.6 | percentage of participants | |
| Number of Scheduled Assessments With Rectal Bleeding Responder Classification | Placebo | Responder at 3 assessment | 7.5 | percentage of participants |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Budesonide | 134 | |
| Overall Study | STARTED | Placebo | 147 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Budesonide | 134 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Placebo | 147 | |
| Overall Study | COMPLETED | Budesonide | 115 | |
| Overall Study | COMPLETED | Placebo | 125 | |
| Overall Study | NOT COMPLETED | Budesonide | 19 | |
| Overall Study | NOT COMPLETED | Placebo | 22 |
Source ClinicalTrials.gov
Adverse events212
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 | Sinusitis | Infections and infestations | Budesonide | 1 | 134 | |
| other | Sinusitis | Infections and infestations | Placebo | 1 | 147 | |
| other | Pyrexia | General disorders | Budesonide | 0 | 134 | |
| other | Pyrexia | General disorders | Placebo | 2 | 147 | |
| other | Lymph node abscess | Infections and infestations | Budesonide | 0 | 134 | |
| other | Lymph node abscess | Infections and infestations | Placebo | 1 | 147 | |
| other | Subcutaneous abscess | Infections and infestations | Budesonide | 0 | 134 | |
| other | Subcutaneous abscess | Infections and infestations | Placebo | 1 | 147 | |
| other | Joint swelling | Musculoskeletal and connective tissue disorders | Budesonide | 0 | 134 | |
| other | Joint swelling | Musculoskeletal and connective tissue disorders | Placebo | 1 | 147 |
1 to 10 of 212Source ClinicalTrials.gov
See all 212 adverse eventsAdverse 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 | 147 |
| Total, other adverse events | Budesonide | 57 | 134 |
| Total, other adverse events | Placebo | 54 | 147 |
| Total, serious adverse events | Budesonide | 3 | 134 |
| Total, serious adverse events | Placebo | 0 | 147 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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.
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/NCT01008423
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