Trial · NCT01349673
The Safety and Tolerability of Budesonide Foam in Participants With Active Ulcerative Proctitis or Proctosigmoiditis
NCT01349673, Phase 3, Terminated, Bausch Health Americas, Inc.; results first posted 2019-08-14
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. The Safety and Tolerability of Budesonide Foam in Participants With Active Ulcerative Proctitis or Proctosigmoiditis. Trials, record NCT01349673. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01349673
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Safety and Tolerability of Budesonide Foam in Participants With Active Ulcerative Proctitis or Proctosigmoiditis
- NCT number
- NCT01349673
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 114 participants, actual
- Lead sponsor
- Bausch Health Americas, Inc.
- Conditions
- Proctitis, Proctosigmoiditis
- Interventions
- Budesonide Foam
- First posted
- 2011-05-06
- Last updated
- 2019-08-14
- Results first posted
- 2019-08-14
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number Of Participants Reporting A Non-serious Adverse Event And A Serious Adverse Event | Baseline through up to Cycle 8 (Cycle=6 weeks) | A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module. |
| Secondary | Clinically Notable Laboratory Parameters | Baseline and Cycle 4 (Cycle=6 weeks) | Clinically notable laboratory parameters are defined as clinical laboratory values outside the reference range. Reference ranges for the clinical notable laboratory parameters: Aspartate Aminotransferase - 0-37 microliters (U/L); Alanine Aminotransferase - 0-47 U/L; Lactate Dehydrogenase - 110-250 U/L. A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module. |
| Secondary | Changes In Baseline In Mean Morning (AM) Fasting Serum Cortisol Levels | Baseline of Cycles 1-4, Day 15 and Day 42 of Cycles 1-4 (Cycle=6 weeks) | Fasting cortisol levels were evaluated, and cortisol was taken in the morning (AM cortisol) approximately 2 to 4 hours after waking. Data for cycles with more than 15 participants at the Cycle Baseline is reported. |
| Secondary | Number of Participants With A Clinically Notable Physical Examination Finding Since Baseline | Baseline through up to Cycle 8 (Cycle=6 weeks) | A full or complete physical examination was performed at the Study Baseline. This physical examination included (but was not limited to): general appearance, head, ear, eyes, nose, throat, respiratory, cardiovascular, gastrointestinal, abdominal, neurological, lymphatic, dermatologic, and musculoskeletal. A symptom-directed physical examination was performed on Visit 2 (Day 1) to Visit 4 (Day 42) per Cycle (at the Investigator's discretion) and as needed for unscheduled clinic visits. A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number Of Participants Reporting A Non-serious Adverse Event And A Serious Adverse Event | Baseline through up to Cycle 8 (Cycle=6 weeks) | All participants who received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Clinically Notable Laboratory Parameters | Baseline and Cycle 4 (Cycle=6 weeks) | All participants who received at least 1 dose of study drug and with non-missing clinical laboratory parameter values at the specified timepoint. | U/L | MEAN |
| SECONDARY | Changes In Baseline In Mean Morning (AM) Fasting Serum Cortisol Levels | Baseline of Cycles 1-4, Day 15 and Day 42 of Cycles 1-4 (Cycle=6 weeks) | All participants who received at least 1 dose of study drug and with non-missing cortisol value at the specified timepoint. | nanomoles per liter (nmol/L) | MEAN |
| SECONDARY | Number of Participants With A Clinically Notable Physical Examination Finding Since Baseline | Baseline through up to Cycle 8 (Cycle=6 weeks) | All participants who received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group17
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number Of Participants Reporting A Non-serious Adverse Event And A Serious Adverse Event | Budesonide Foam | Non-serious Adverse Event | 66 | Participants | |
| Number Of Participants Reporting A Non-serious Adverse Event And A Serious Adverse Event | Budesonide Foam | Serious Adverse Event | 0 | Participants | |
| Clinically Notable Laboratory Parameters | Budesonide Foam | Aspartate Aminotransferase, Baseline | 21.7 | Full Range 12 to 37 | U/L |
| Clinically Notable Laboratory Parameters | Budesonide Foam | Aspartate Aminotransferase, Cycle 4 | 92.3 | Full Range 21 to 440 | U/L |
| Clinically Notable Laboratory Parameters | Budesonide Foam | Alanine Aminotransferase, Baseline | 23.0 | Full Range 7 to 58 | U/L |
| Clinically Notable Laboratory Parameters | Budesonide Foam | Alanine Aminotransferase, Cycle 4 | 119.3 | Full Range 13 to 596 | U/L |
| Clinically Notable Laboratory Parameters | Budesonide Foam | Lactate Dehydrogenase, Baseline | 154.1 | Full Range 82 to 223 | U/L |
| Clinically Notable Laboratory Parameters | Budesonide Foam | Lactate Dehydrogenase, Cycle 4 | 228.5 | Full Range 143 to 506 | U/L |
| Changes In Baseline In Mean Morning (AM) Fasting Serum Cortisol Levels | Budesonide Foam | Cycle 1, Day 15 | -62.7 | Standard Deviation 149.61 | nanomoles per liter (nmol/L) |
| Changes In Baseline In Mean Morning (AM) Fasting Serum Cortisol Levels | Budesonide Foam | Cycle 1, Day 42 | 0.9 | Standard Deviation 170.78 | nanomoles per liter (nmol/L) |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Budesonide Foam | 114 | |
| Overall Study | Participants Entered Cycle 1 | Budesonide Foam | 114 | |
| Overall Study | Participants Entered Cycle 2 | Budesonide Foam | 65 | |
| Overall Study | Participants Entered Cycle 3 | Budesonide Foam | 41 | |
| Overall Study | Participants Entered Cycle 4 | Budesonide Foam | 22 | |
| Overall Study | Participants Entered Cycle 5 | Budesonide Foam | 12 | |
| Overall Study | Participants Entered Cycle 6 | Budesonide Foam | 5 | |
| Overall Study | Participants Entered Cycle 7 | Budesonide Foam | 3 | |
| Overall Study | Participants Entered Cycle 8 | Budesonide Foam | 1 | |
| Overall Study | Received At Least 1 Dose Of Study Drug | Budesonide Foam | 114 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events14
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 | Adrenal insufficiency | Endocrine disorders | Budesonide Foam | 3 | 114 | |
| other | Abdominal pain | Gastrointestinal disorders | Budesonide Foam | 9 | 114 | |
| other | Anorectal discomfort | Gastrointestinal disorders | Budesonide Foam | 3 | 114 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Budesonide Foam | 3 | 114 | |
| other | Colitis ulcerative | Gastrointestinal disorders | Budesonide Foam | 3 | 114 | |
| other | Diarrhoea | Gastrointestinal disorders | Budesonide Foam | 3 | 114 | |
| other | Haemorrhoids | Gastrointestinal disorders | Budesonide Foam | 4 | 114 | |
| other | Nausea | Gastrointestinal disorders | Budesonide Foam | 4 | 114 | |
| other | Vomiting | Gastrointestinal disorders | Budesonide Foam | 4 | 114 | |
| other | Nasopharyngitis | Infections and infestations | Budesonide Foam | 4 | 114 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Budesonide Foam | ||
| Total, other adverse events | Budesonide Foam | 66 | 114 |
| Total, serious adverse events | Budesonide Foam | 0 | 114 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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.
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/NCT01349673
GET https://conductscience.org/api/trials/v1/NCT01349673/registered