Clinical trial NCT01349673: The Safety and Tolerability of Budesonide Foam in Participants With Active Ulcerative Proctitis or Proctosigmoiditis
Official title: A Phase 3, Open Label, Multicenter Study to Assess the Safety and Tolerability of Budesonide Foam in Subjects With Active Ulcerative Proctitis or Proctosigmoiditis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
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
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
First posted: 2011-05-06
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

Detailed description: This is a Phase 3, multicenter, open-label study in participants who previously participated in a Salix-sponsored budesonide rectal foam study for the treatment of UP or UPS. Approximately 300 participants were to be enrolled into the study and receive budesonide foam cyclically for 6 weeks (twice a day \[BID\] for 2 weeks and once daily \[QD\] for 4 weeks). The study was to continue until regulatory approval of budesonide foam occurred or the sponsor decided to terminate the study.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Number Of Participants Reporting A Non-serious Adverse Event And A Serious Adverse Event
timeFrame: Baseline through up to Cycle 8 (Cycle=6 weeks)
Secondary outcomes:
measure: Clinically Notable Laboratory Parameters
timeFrame: Baseline and Cycle 4 (Cycle=6 weeks)
measure: Changes In Baseline In Mean Morning (AM) Fasting Serum Cortisol Levels
timeFrame: Baseline of Cycles 1-4, Day 15 and Day 42 of Cycles 1-4 (Cycle=6 weeks)
measure: Number of Participants With A Clinically Notable Physical Examination Finding Since Baseline
timeFrame: Baseline through up to Cycle 8 (Cycle=6 weeks)
Other outcomes:
Locations:
city: Houston
country: United States
facility: Gastroenterology Consultants, PA
state: Texas
Study officials:
References: