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

NCT ID: NCT01008423

Last Updated: 2019-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 281 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-20
• Study Completion Date: 2013-03-18

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 dose and 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 dose and 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 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 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

Dothan, Alabama, United States

Mesa, Arizona, United States

Tucson, Arizona, United States

Little Rock, Arkansas, United States

Chula Vista, California, United States

Garden Grove, California, United States

Mission Hills, California, United States

Monterey, California, United States

Roseville, California, United States

San Francisco, California, United States

Lafayette, Colorado, United States

Bristol, Connecticut, United States

Hamden, Connecticut, United States

Altamonte Springs, Florida, United States

Cape Coral, Florida, United States

Hialeah, Florida, United States

North Miami Beach, Florida, United States

Winter Park, Florida, United States

Macon, Georgia, United States

Marietta, Georgia, United States

Suwanee, Georgia, United States

Moline, Illinois, United States

Davenport, Iowa, United States

Topeka, Kansas, United States

Metairie, Louisiana, United States

Annapolis, Maryland, United States

Hagerstown, Maryland, United States

Prince Frederick, Maryland, United States

Silver Springs, Maryland, United States

Chesterfield, Michigan, United States

Rochester, Michigan, United States

Tupelo, Mississippi, United States

St Louis, Missouri, United States

Egg Harbor, New Jersey, United States

Marlton, New Jersey, United States

Great Neck, New York, United States

Mineola, New York, United States

New York, New York, United States

North Massapequa, New York, United States

Stony Brook, New York, United States

Asheville, North Carolina, United States

Fayetteville, North Carolina, United States

Greensboro, North Carolina, United States

Jacksonville, North Carolina, United States

New Bern, North Carolina, United States

Raleigh, North Carolina, United States

Rocky Mount, North Carolina, United States

Wilmington, North Carolina, United States

Beachwood, Ohio, United States

Tulsa, Oklahoma, United States

Portland, Oregon, United States

Germantown, Tennessee, United States

Houston, Texas, United States

La Porte, Texas, United States

Pasadena, Texas, United States

Plano, Texas, United States

San Antonio, Texas, United States

Ogden, Utah, United States

West Valley City, Utah, United States

Chesapeake, Virginia, United States

Lynchburg, Virginia, United States

Monroe, 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

BUCF3002

Identifier Type: -

Identifier Source: org_study_id