Efficacy and Safety of Budesonide Foam for Participants With Active Mild to Moderate Ulcerative Proctitis or Proctosigmoiditis

NCT ID: NCT01008410

Last Updated: 2019-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 265 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-17
• Study Completion Date: 2013-04-29

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).

Conditions

Proctitis; Proctosigmoiditis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Budesonide

Participants who were diagnosed with active mild to moderate UP or UPS, will receive 2 milligrams (mg)/25 milliliter (mL) of budesonide foam, rectally twice daily for a period of 2 weeks followed by 2 mg/25 mL of budesonide foam, rectally once daily for a period of 4 weeks.

Group Type: EXPERIMENTAL

Budesonide

Intervention Type: DRUG

Budesonide will be administered as per the dose and schedule specified in the respective arm.

Placebo

Participants who were diagnosed with active mild to moderate UP or UPS will receive 25 mL of placebo matching to budesonide foam twice daily for a period of 2 weeks followed by once daily for a period of 4 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo matching to budesonide will be administered as per the schedule specified in the respective arm.

Interventions

Budesonide

Budesonide will be administered as per the dose and schedule specified in the respective arm.

Intervention Type: DRUG

Placebo

Placebo matching to budesonide will be administered as per the schedule specified in the respective arm.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bausch Health Americas, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Director

Role:

Bausch Health Companies

Locations

Birmingham, Alabama, United States

Huntsville, Alabama, United States

Jonesboro, Arkansas, United States

National City, California, United States

Oakland, California, United States

Orange, California, United States

San Carlos, California, United States

San Diego, California, United States

Lakewood, Colorado, United States

Littleton, Colorado, United States

Bridgeport, Connecticut, United States

Boynton Beach, Florida, United States

Hollywood, Florida, United States

Inverness, Florida, United States

Largo, Florida, United States

Maitland, Florida, United States

Miami, Florida, United States

New Smyrna Beach, Florida, United States

Port Orange, Florida, United States

Tampa, Florida, United States

Trinity, Florida, United States

Zephyrhills, Florida, United States

Atlanta, Georgia, United States

Marietta, Georgia, United States

Newnan, Georgia, United States

Bolingbrook, Illinois, United States

Clive, Iowa, United States

Baton Rouge, Louisiana, United States

Shreveport, Louisiana, United States

Lutherville, Maryland, United States

Weymouth, Massachusetts, United States

Troy, Michigan, United States

Wyoming, Michigan, United States

Jackson, Mississippi, United States

Mexico, Missouri, United States

St Louis, Missouri, United States

Elizabeth, New Jersey, United States

Vineland, New Jersey, United States

Lake Success, New York, United States

Boone, North Carolina, United States

Chapel Hill, North Carolina, United States

Charlotte, North Carolina, United States

Huntersville, North Carolina, United States

LaPorte, North Carolina, United States

Morganton, North Carolina, United States

Cincinnati, Ohio, United States

Gallipolis, Ohio, United States

Mentor, Ohio, United States

Norman, Oklahoma, United States

Pittsburgh, Pennsylvania, United States

Columbia, South Carolina, United States

Franklin, Tennessee, United States

Germantown, Tennessee, United States

Jackson, Tennessee, United States

Kingsport, Tennessee, United States

Nashville, Tennessee, United States

Houston, Texas, United States

Plano, Texas, United States

San Antonio, Texas, United States

Tyler, Texas, United States

Bellevue, Washington, United States

Vancouver, Washington, United States

Milwaukee, Wisconsin, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 27416045 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 25644096 (View on PubMed)

Other Identifiers

BUCF3001

Identifier Type: -

Identifier Source: org_study_id