The Safety and Tolerability of Budesonide Foam in Participants With Active Ulcerative Proctitis or Proctosigmoiditis

NCT01349673 | Terminated Phase 3 Results

• 1 other identifier: BFPS3073
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate safety and tolerability of cyclically-dosed rectal budesonide foam in participants with active ulcerative proctitis (UP) or ulcerative proctosigmoiditis (UPS).

Conditions

Proctitis; Proctosigmoiditis

Keywords

Open-label; 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)

• Number Of Participants Reporting A Non-serious Adverse Event And A Serious Adverse Event

  A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.

  Baseline through up to Cycle 8 (Cycle=6 weeks)

Secondary Outcomes (3)

• Clinically Notable Laboratory Parameters

  Baseline and Cycle 4 (Cycle=6 weeks)

• Changes In Baseline In Mean Morning (AM) Fasting Serum Cortisol Levels

  Baseline of Cycles 1-4, Day 15 and Day 42 of Cycles 1-4 (Cycle=6 weeks)

• Number of Participants With A Clinically Notable Physical Examination Finding Since Baseline

  Baseline through up to Cycle 8 (Cycle=6 weeks)

Study Arms (1)

Budesonide Foam

EXPERIMENTAL

Participants administered topical rectal budesonide foam at 2 mg/25 mL BID (morning and 12 hours later) for 2 weeks followed by 2 mg/25 mL QD (in the evenings) for 4 weeks for up to 8 cycles. After Cycle 1, participants needed to qualify to be able to participate in subsequent cycles. Participants underwent a 48-hour study drug washout period between each cycle.

Drug: Budesonide Foam

Interventions

Budesonide Foam DRUG

Topical

Budesonide Foam

Eligibility Criteria

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

You may qualify if:

• Male or non-pregnant, non-breast-feeding females ≥18 years old.
• Participant was previously diagnosed with active mild to moderate UP/UPS and was currently experiencing symptoms of active UP/UPS disease after having completed participation in Salix's BUCF3001 (NCT01008410) or BUCF3002 (NCT01008423) study.
• Willingness to undergo sigmoidoscopy.

You may not qualify if:

• Active systemic, ocular, or cutaneous infection (for example, parasitic, fungal, amoebic, viral, or bacterial disease).
• History of sclerosing cholangitis, cirrhosis, or hepatic impairment, including chronic hepatitis of any etiology.
• Participant took systemic, inhaled, oral, topical, or rectal corticosteroids (other than budesonide rectal foam) within 7 days of starting a treatment cycle.
• Participant took ketoconazole and other potent CYP3A4 inhibitors within 7 days of starting a treatment cycle.
• Participant took diuretics with cardiac glycosides.
• Unstable significant cardiovascular, hepatic, renal, endocrine, neurologic, or pulmonary disease.

Sponsors & Collaborators

• Bausch Health Americas, Inc.: lead

Study Sites (1)

Gastroenterology Consultants, PA

Houston, Texas, 77034, United States

Location

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

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and Symptoms

Results Point of Contact

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

Lindsey.Mathew@bauschhealth.com

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2011
• First Posted: May 6, 2011
• Study Start: May 31, 2011
• Primary Completion: December 31, 2014
• Study Completion: December 31, 2014
• Last Updated: August 14, 2019
• Results First Posted: August 14, 2019

Record last verified: 2019-07

Locations

US (1)