Clinical trial NCT01008410: Efficacy and Safety of Budesonide Foam for Participants With Active Mild to Moderate Ulcerative Proctitis or Proctosigmoiditis
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Budesonide Foam (2 mg/25 mL BID for 2 Weeks, Followed by 2 mg/25 mL QD for 4 Weeks) Versus Placebo in Subjects With Active Mild to Moderate Ulcerative Proctitis or Proctosigmoiditis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Proctitis
Proctosigmoiditis
Keywords: Proctitis
Proctosigmoiditis
Ulcerative
Salix
Budesonide foam
Budesonide
Rectal
Gastrointestinal
Colitis
UC
UP
UPS
Additional relevant MeSH terms:
Proctocolitis
Ulcer
Colitis, Ulcerative
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Rectal Diseases
Intestinal Diseases
Colonic Diseases
Sigmoid Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Inflammatory Agents
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
First posted: 2009-11-05
Enrollment: 265
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 Modified Mayo Disease Activity Index (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 (\<) 7.5 grams /deciliter (g/dL).
* History of sclerosing cholangitis, cirrhosis, or hepatic impairment.
* Renal disease manifested by greater 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 human immunodeficiency virus (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.

Primary outcomes:
measure: Percentage of Participants Who Achieved Remission
timeFrame: Week 6
Secondary outcomes:
measure: Percentage of Participants Who Achieved a Rectal Bleeding MMDAI Subscale Score of 0 at End of Week 6
timeFrame: Week 6
measure: Number of Scheduled Assessments With Rectal Bleeding Responder Classification
timeFrame: Weeks 1, 2, 4, and 6
measure: Percentage of Participants Who Achieved an Endoscopy MMDAI Subscale Score of 0 or 1 at End of Week 6
timeFrame: Week 6
measure: 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
timeFrame: Week 6
measure: 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
timeFrame: Week 6
measure: Percentage of Participants Who Achieved Improvement of >=1 Point From Baseline in the MMDAI Endoscopy Subscale Score at End of Week 6
timeFrame: Week 6
measure: Percentage of Participants Who Achieved Improvement of >=1 Point From Baseline in the MMDAI Rectal Bleeding Subscale Score at End of Week 6
timeFrame: Week 6
measure: 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
timeFrame: Week 6
measure: Mean Change From Baseline to Week 6 in MMDAI Total Score and Subscale Scores
timeFrame: Baseline, Week 6
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Huntsville
country: United States
state: Alabama
city: Jonesboro
country: United States
state: Arkansas
city: National City
country: United States
state: California
city: Oakland
country: United States
state: California
city: Orange
country: United States
state: California
city: San Carlos
country: United States
state: California
city: San Diego
country: United States
state: California
city: Lakewood
country: United States
state: Colorado
city: Littleton
country: United States
state: Colorado
city: Bridgeport
country: United States
state: Connecticut
city: Boynton Beach
country: United States
state: Florida
city: Hollywood
country: United States
state: Florida
city: Inverness
country: United States
state: Florida
city: Largo
country: United States
state: Florida
city: Maitland
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: New Smyrna Beach
country: United States
state: Florida
city: Port Orange
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Trinity
country: United States
state: Florida
city: Zephyrhills
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Marietta
country: United States
state: Georgia
city: Newnan
country: United States
state: Georgia
city: Bolingbrook
country: United States
state: Illinois
city: Clive
country: United States
state: Iowa
city: Baton Rouge
country: United States
state: Louisiana
city: Shreveport
country: United States
state: Louisiana
city: Lutherville
country: United States
state: Maryland
city: Weymouth
country: United States
state: Massachusetts
city: Troy
country: United States
state: Michigan
city: Wyoming
country: United States
state: Michigan
city: Jackson
country: United States
state: Mississippi
city: Mexico
country: United States
state: Missouri
city: Saint Louis
country: United States
state: Missouri
city: Elizabeth
country: United States
state: New Jersey
city: Vineland
country: United States
state: New Jersey
city: Lake Success
country: United States
state: New York
city: Boone
country: United States
state: North Carolina
city: Chapel Hill
country: United States
state: North Carolina
city: Charlotte
country: United States
state: North Carolina
city: Huntersville
country: United States
state: North Carolina
city: LaPorte
country: United States
state: North Carolina
city: Morganton
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Gallipolis
country: United States
state: Ohio
city: Mentor
country: United States
state: Ohio
city: Norman
country: United States
state: Oklahoma
city: Pittsburgh
country: United States
state: Pennsylvania
city: Columbia
country: United States
state: South Carolina
city: Franklin
country: United States
state: Tennessee
city: Germantown
country: United States
state: Tennessee
city: Jackson
country: United States
state: Tennessee
city: Kingsport
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Houston
country: United States
state: Texas
city: Plano
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Tyler
country: United States
state: Texas
city: Bellevue
country: United States
state: Washington
city: Vancouver
country: United States
state: Washington
city: Milwaukee
country: United States
state: Wisconsin
Study officials:
affiliation: Bausch Health Companies
name: Study Director
References:
citation: Bosworth BP, Sandborn WJ, Rubin DT, Harper JR. Baseline Oral 5-ASA Use and Efficacy and Safety of Budesonide Foam in Patients with Ulcerative Proctitis and Ulcerative Proctosigmoiditis: Analysis of 2 Phase 3 Studies. Inflamm Bowel Dis. 2016 Aug;22(8):1881-6. doi: 10.1097/MIB.0000000000000860.
citation: Sandborn WJ, Bosworth B, Zakko S, Gordon GL, Clemmons DR, Golden PL, Rolleri RL, Yu J, Barrett AC, Bortey E, Paterson C, Forbes WP. Budesonide foam induces remission in patients with mild to moderate ulcerative proctitis and ulcerative proctosigmoiditis. Gastroenterology. 2015 Apr;148(4):740-750.e2. doi: 10.1053/j.gastro.2015.01.037. Epub 2015 Jan 30.