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

NCT01008410 | Completed Phase 3 Results

• 1 other identifier: BUCF3001
• Study Type: interventional
• Target: 265
• Locations: 1 country
• Sites: 63

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

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

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Who Achieved Remission

  Remission was a combined assessment of clinical and endoscopic variables, defined as an endoscopy score of less than or equal to (\<=) 1, a rectal bleeding score of 0, and an improvement or no change from baseline in stool frequency subscales of the Modified Mayo Disease Activity Index (MMDAI) at the end of 6 weeks of treatment. MMDAI was used to assess the overall disease activity for each participant. MMDAI evaluated 4 indices: stool frequency, rectal bleeding, physician's global assessment (PGA) and endoscopy findings each on a scale of 0 to 3 with a maximum total score of 12. Stool frequency MMDAI subscore ranged from 0-3, where 0 indicated normal number of stools per day and 3 indicated 5 or more stools than normal. Rectal bleeding MMDAI subscore ranged from 0-3, where 0 indicated no blood seen and 3 indicated blood alone passed. Endoscopy MMDAI subscore ranged from 0-3, where 0 indicated normal or inactive disease and 3 indicated severe disease (spontaneous bleeding, ulceration).

  Week 6

Secondary Outcomes (9)

• Percentage of Participants Who Achieved a Rectal Bleeding MMDAI Subscale Score of 0 at End of Week 6

  Week 6

• Number of Scheduled Assessments With Rectal Bleeding Responder Classification

  Weeks 1, 2, 4, and 6

• Percentage of Participants Who Achieved an Endoscopy MMDAI Subscale Score of 0 or 1 at End of Week 6

  Week 6

• 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

  Week 6

• 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

  Week 6

Study Arms (2)

Budesonide

EXPERIMENTAL

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.

Drug: Budesonide

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Budesonide DRUG

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

Budesonide

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bausch Health Americas, Inc.: lead

Study Sites (63)

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Birmingham, Alabama, United States

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Huntsville, Alabama, United States

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Jonesboro, Arkansas, United States

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National City, California, United States

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Oakland, California, United States

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Orange, California, United States

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San Carlos, California, United States

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San Diego, California, United States

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Lakewood, Colorado, United States

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Littleton, Colorado, United States

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Bridgeport, Connecticut, United States

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Boynton Beach, Florida, United States

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Hollywood, Florida, United States

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Inverness, Florida, United States

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Largo, Florida, United States

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Maitland, Florida, United States

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Miami, Florida, United States

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New Smyrna Beach, Florida, United States

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Port Orange, Florida, United States

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Tampa, Florida, United States

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Trinity, Florida, United States

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Zephyrhills, Florida, United States

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Atlanta, Georgia, United States

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Marietta, Georgia, United States

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Newnan, Georgia, United States

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Bolingbrook, Illinois, United States

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Clive, Iowa, United States

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Baton Rouge, Louisiana, United States

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Shreveport, Louisiana, United States

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Lutherville, Maryland, United States

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Weymouth, Massachusetts, United States

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Troy, Michigan, United States

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Wyoming, Michigan, United States

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Jackson, Mississippi, United States

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Mexico, Missouri, United States

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St Louis, Missouri, United States

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Elizabeth, New Jersey, United States

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Vineland, New Jersey, United States

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Lake Success, New York, United States

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Boone, North Carolina, United States

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Chapel Hill, North Carolina, United States

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Charlotte, North Carolina, United States

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Huntersville, North Carolina, United States

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LaPorte, North Carolina, United States

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Morganton, North Carolina, United States

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Cincinnati, Ohio, United States

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Gallipolis, Ohio, United States

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Mentor, Ohio, United States

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Norman, Oklahoma, United States

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Pittsburgh, Pennsylvania, United States

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Columbia, South Carolina, United States

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Franklin, Tennessee, United States

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Germantown, Tennessee, United States

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Jackson, Tennessee, United States

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Kingsport, Tennessee, United States

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Nashville, Tennessee, United States

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Houston, Texas, United States

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Plano, Texas, United States

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San Antonio, Texas, United States

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Tyler, Texas, United States

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Bellevue, Washington, United States

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Vancouver, Washington, United States

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Milwaukee, Wisconsin, United States

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Related Publications (2)

• 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.

  PMID: 27416045 DERIVED

• 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.

  PMID: 25644096 DERIVED

MeSH Terms

Conditions

Proctitis; Proctocolitis; Ulcer; Colitis; Colitis, Ulcerative; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Rectal Diseases; Intestinal Diseases; Colonic Diseases; Sigmoid Diseases; Pathologic Processes; Inflammatory Bowel Diseases

Interventions

Budesonide

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Director of Clinical Operations
• Organization: Bausch Health Companies

Lindsey.Mathew@bauschhealth.com

Study Officials

• Study Director

  Bausch Health Companies

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2009
• First Posted: November 5, 2009
• Study Start: November 17, 2009
• Primary Completion: April 29, 2013
• Study Completion: April 29, 2013
• Last Updated: August 14, 2019
• Results First Posted: August 14, 2019

Record last verified: 2019-07

Locations

US (63)