Phase 3
N=281
Efficacy and Safety of Budesonide Foam for Participants With Active Mild to Moderate Ulcerative Proctitis or Proctosigmoiditis
Proctitis · Proctosigmoiditis
Bottom Line
View on ClinicalTrials.gov: NCT01008423 ↗Enrolled (actual)
281
Serious AEs
1.1%
Results posted
Aug 2019
Primary outcome: Primary: Percentage of Participants Who Achieved Remission — 44.0; 22.4 percentage of participants — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Budesonide (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bausch Health Americas, Inc.
- Primary completion
- Mar 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Achieved Remission |
44.0; 22.4 | <0.0001 sig |
| SECONDARY Percentage of Participants Who Achieved a Rectal Bleeding MMDAI Subscale Score of 0 at End of Week 6 |
50.0; 28.6 | — |
| SECONDARY Number of Scheduled Assessments With Rectal Bleeding Responder Classification |
8.2; 18.4; 16.4; 17.0; 21.6; 7.5 | — |
| SECONDARY Percentage of Participants Who Achieved an Endoscopy MMDAI Subscale Score of 0 or 1 at End of Week 6 |
56.0; 36.7 | — |
| 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 |
46.3; 23.8 | — |
| 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 |
49.3; 28.6 | — |
| SECONDARY Percentage of Participants Who Achieved Improvement of >=1 Point From Baseline in the MMDAI Endoscopy Subscale Score at End of Week 6 |
57.5; 38.8 | — |
| SECONDARY Percentage of Participants Who Achieved Improvement of >=1 Point From Baseline in the MMDAI Rectal Bleeding Subscale Score at End of Week 6 |
72.4; 56.5 | — |
| 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 |
53.7; 34.0 | — |
| SECONDARY Mean Change From Baseline to Week 6 in MMDAI Total Score and Subscale Scores |
1.7; 1.8; -0.8; -0.5; 2.1; 2.1 | — |
Summary
The purpose of this study is to establish the efficacy profile of rectally administered budesonide foam, as compared to an equivalent volume of rectally administered placebo foam over the same dosing schedule, in participants who present with a diagnosis of active, mild to moderate, ulcerative proctitis (UP) or ulcerative proctosigmoiditis (UPS). During the study, eligible participants will be allowed to maintain previously established oral 5-aminosalicylic acid (5-ASA) treatment at doses up to 4.8 grams/day (g/day).
Eligibility Criteria
Inclusion Criteria
- Voluntarily sign written informed consent.
- Male or non-pregnant and non-lactating females.
- Confirmed diagnosis (by endoscopy procedure) of active, mild to moderate UP or UPS, with disease extending at least 5 centimeters (cm) but no further than 40 cm from the anal verge.
- Must possess a baseline MMDAI score between 5 and 10.
Exclusion Criteria
- History or current diagnosis of Crohn's disease and indeterminate colitis.
- Prior gastrointestinal surgery except appendectomy and hernia.
- Concomitant active gastrointestinal disease or distortion of intestinal anatomy.
- History of diverticulitis, collagenous colitis, celiac disease, recurrent pancreatic or known gallbladder disease.
- Uncontrolled, previously diagnosed type 1 or 2 diabetes mellitus.
- Uncontrolled abnormal thyroid function.
- Unstable significant cardiovascular, endocrine, neurologic or pulmonary disease.
- Hemoglobin levels less than ( ) 2.0 milligrams/deciliter (mg/dL) serum creatinine.
- History of avascular hip necrosis, active tuberculosis, ocular herpes simplex or ocular varicella zoster, malignant disease, and HIV or hepatitis B or C.
- Adrenal insufficiency.
- Active systemic or cutaneous infection or toxic megacolon, fistula, perforation or abscess.
- History of uncontrolled psychiatric disorders or seizure disorders.
- History of asthma requiring ongoing use of inhaled steroids.
- Recent history of drug or alcohol abuse.
- Positive stool test for bacterial pathogens, Clostridium difficile toxin, or ovum and parasites.
- Vaccination within 28 days prior to randomization.
- Allergies to budesonide or to any other items used in its preparation.
- Participation in another clinical trial in the past 30 days.
- Pregnant or at risk of pregnancy.
- Taking a prohibited medication. Some medications to treat UP/UPS are prohibited during participation in the study, including laxatives and anti-diarrhea medications; however, oral 5-ASA agents at doses up to 4.8 g/day and daily fiber supplements are allowed. Other medications (e.g., antibiotics, anti-seizure and anti-coagulant medicines) are also prohibited.
Data sourced from ClinicalTrials.gov (NCT01008423). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.