A Phase 3 interventional study of Budesonide Foam in Proctitis and Proctosigmoiditis, sponsored by Bausch Health Americas, Inc.. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-08-14.
Sponsored by Bausch Health Americas, Inc. (part of Bausch Health Companies Inc.) · Phase 3, Interventional, and Treatment
The purpose of this study is to evaluate safety and tolerability of cyclically-dosed rectal budesonide foam in participants with active ulcerative proctitis (UP) or ulcerative proctosigmoiditis (UPS).
This is a Phase 3, multicenter, open-label study in participants who previously participated in a Salix-sponsored budesonide rectal foam study for the treatment of UP or UPS. Approximately 300 participants were to be enrolled into the study and receive budesonide foam cyclically for 6 weeks (twice a day [BID] for 2 weeks and once daily [QD] for 4 weeks). The study was to continue until regulatory approval of budesonide foam occurred or the sponsor decided to terminate the study.
27 studies on the registry are indexed under Proctitis; 6 are open to participants now.
This study's enrollment of 114 is close to the median of 122 across 23 interventional studies indexed under Proctitis.
Browse Proctitis studies →Bausch Health Americas, Inc. is the lead sponsor of 213 studies on the registry; 7 are open to participants now.
Of its 25 completed or terminated interventional studies of FDA-regulated products, 18 (72%) have results posted.
First submitted after Bausch Health Americas, Inc. became part of Bausch Health Companies Inc..
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants administered topical rectal budesonide foam at 2 mg/25 mL BID (morning and 12 hours later) for 2 weeks followed by 2 mg/25 mL QD (in the evenings) for 4 weeks for up to 8 cycles. After Cycle 1, participants needed to qualify to be able to participate in subsequent cycles. Participants underwent a 48-hour study drug washout period between each cycle.
Drug: Budesonide Foam
Topical
Number Of Participants Reporting A Non-serious Adverse Event And A Serious Adverse Event
A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.
Time frame: Baseline through up to Cycle 8 (Cycle=6 weeks)
Clinically Notable Laboratory Parameters
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.
Time frame: Baseline and Cycle 4 (Cycle=6 weeks)
Changes In Baseline In Mean Morning (AM) Fasting Serum Cortisol Levels
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.
Time frame: Baseline of Cycles 1-4, Day 15 and Day 42 of Cycles 1-4 (Cycle=6 weeks)
Number of Participants With A Clinically Notable Physical Examination Finding Since Baseline
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.
Time frame: Baseline through up to Cycle 8 (Cycle=6 weeks)
| Milestone | Budesonide Foam |
|---|---|
| Started | 114 |
| Participants entered cycle 1 | 114 |
| Participants entered cycle 2 | 65 |
| Participants entered cycle 3 | 41 |
| Participants entered cycle 4 | 22 |
| Participants entered cycle 5 | 12 |
| Participants entered cycle 6 | 5 |
| Participants entered cycle 7 | 3 |
| Participants entered cycle 8 | 1 |
| Received at least 1 dose of study drug | 114 |
| Completed | 0 |
| Not completed | 114 |
| Withdrew: Progression of disease past 40 cm | 1 |
| Withdrew: No longer qualified for study | 1 |
| Withdrew: Site closure | 10 |
| Withdrew: Withdrawal by subject | 21 |
| Withdrew: Lost to follow-up | 6 |
| Withdrew: Adverse event | 17 |
| Withdrew: Study terminated by sponsor | 50 |
| Withdrew: Lack of efficacy | 8 |
A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.
| Participants | Budesonide Foam |
|---|---|
| Non-serious Adverse Event | 66 |
| Serious Adverse Event | 0 |
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.
| U/L | Budesonide Foam |
|---|---|
| Aspartate Aminotransferase, Baseline | 21.7 (12 to 37) |
| Aspartate Aminotransferase, Cycle 4 | 92.3 (21 to 440) |
| Alanine Aminotransferase, Baseline | 23.0 (7 to 58) |
| Alanine Aminotransferase, Cycle 4 | 119.3 (13 to 596) |
| Lactate Dehydrogenase, Baseline | 154.1 (82 to 223) |
| Lactate Dehydrogenase, Cycle 4 | 228.5 (143 to 506) |
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.
| nanomoles per liter (nmol/L) | Budesonide Foam |
|---|---|
| Cycle 1, Day 15 | -62.7 ± 149.61 |
| Cycle 1, Day 42 | 0.9 ± 170.78 |
| Cycle 2, Day 15 | -40.1 ± 165.65 |
| Cycle 2, Day 42 | -5.8 ± 183.16 |
| Cycle 3, Day 15 | -25.5 ± 175.75 |
| Cycle 3, Day 42 | -10.4 ± 174.92 |
| Cycle 4, Day 15 | -87.8 ± 186.11 |
| Cycle 4, Day 42 | -7.1 ± 148.52 |
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.
| Participants | Budesonide Foam |
|---|---|
| Number of Participants With A Clinically Notable Physical Examination Finding Since Baseline | 17 |
Collected over Baseline through up to Cycle 8 (Cycle=6 weeks). Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Budesonide Foam | — | 0/114 (0%) | 66/114 (57.9%) |
| Event | Budesonide Foam |
|---|---|
| Blood cortisol decreasedInvestigations | 20/114 |
| Abdominal painGastrointestinal disorders | 9/114 |
| HeadacheNervous system disorders | 8/114 |
| HaemorrhoidsGastrointestinal disorders | 4/114 |
| NauseaGastrointestinal disorders | 4/114 |
| VomitingGastrointestinal disorders | 4/114 |
| NasopharyngitisInfections and infestations | 4/114 |
| Adrenal insufficiencyEndocrine disorders | 3/114 |
| Anorectal discomfortGastrointestinal disorders | 3/114 |
| Abdominal pain upperGastrointestinal disorders | 3/114 |
All participants who received at least 1 dose of study drug.
| Age, Continuous(years) | Budesonide Foam |
|---|---|
| Mean | 44.2 ± 12.78 |
| Sex: Female, Male(Participants) | Budesonide Foam |
|---|---|
| Female | 64 |
| Male | 50 |
This study is terminated, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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