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

Bausch Health

Status and phase: Completed; Phase 3

Conditions: Proctitis; Proctosigmoiditis

Treatments: Drug: Budesonide; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01008410

BUCF3001

Details and patient eligibility

About

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).

Enrollment: 265 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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265 participants in 2 patient groups, including a placebo group

Budesonide

Experimental group

Description:

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.

Treatment:

Drug: Budesonide

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo