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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Salix Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01008423
First received: November 4, 2009
Last updated: May 17, 2013
Last verified: November 2012
  Purpose

The purpose of this study is to establish the efficacy profile of rectally administered budesonide foam administered as 2mg/25mL BID for 2 weeks followed by 2mg/25mL QD for 4 weeks, as compared to an equivalent volume of rectally administered placebo foam over the same dosing schedule, in subjects who present with a diagnosis of active, mild to moderate, ulcerative proctitis (UP) or ulcerative proctosigmoiditis (UPS). During the study, eligible subjects will be allowed to maintain previously established oral 5-ASA treatment at doses up to 4.8g/day.


Condition Intervention Phase
Proctitis
Proctosigmoiditis
Drug: Budesonide
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Budesonide Foam Versus Placebo in Subjects With Active Mild to Moderate Ulcerative Proctitis or Proctosigmoiditis

Resource links provided by NLM:


Further study details as provided by Salix Pharmaceuticals:

Primary Outcome Measures:
  • The proportion of subjects who achieve remission. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Enrollment: 281
Study Start Date: November 2009
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Budesonide
Budesonide rectal foam
Drug: Budesonide
2mg/25mL BID for 2 weeks followed by 2mg/25mL QD for 4 weeks
Placebo Comparator: Placebo
Placebo foam
Drug: Placebo
Placebo foam/25mL BID for 2 weeks followed by 2mg/25mL QD for 4 weeks

Detailed Description:

This is a Phase 3, randomized, double-blind, placebo-controlled, multi-center study to assess the efficacy and safety of budesonide foam in subjects with active mild to moderate proctitis or proctosigmoiditis. Approximately 430 subjects will be enrolled into the study and receive either placebo foam or budesonide foam twice a day for 2 weeks followed by once a day for 4 weeks. Participation in the study will last approximately 11 weeks, depending on the timing of study visits.

During the study, eligible subjects will be allowed to maintain previously established oral 5-ASA treatment at doses up to 4.8g/day. Periodic safety monitoring, including physical examinations, vitals, laboratory testing, and recording of AEs and concomitant medications, will be performed during the study

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Voluntarily sign written informed consent.
  • Male or non-pregnant and non-lactating females ≥18 years of age.
  • Confirmed diagnosis (by endoscopy procedure) of active, mild to moderate ulcerative proctitis or proctosigmoiditis extending no further than 40cm from the anal verge.
  • Must possess a baseline MMDAI score between 5 and 10.
  • Visible blood in stool.

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 < 7.5 g/dL.
  • History of sclerosing cholangitis, cirrhosis, or hepatic impairment.
  • Renal disease manifested by > 2.0mg/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, C diff or O&P.
  • 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 4.8g/day and daily fiber supplements are allowed. Other medications (e.g., antibiotics, anti-seizure and anti-coagulant medicines) are also prohibited.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01008423

  Show 62 Study Locations
Sponsors and Collaborators
Salix Pharmaceuticals
  More Information

No publications provided

Responsible Party: Salix Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01008423     History of Changes
Other Study ID Numbers: BUCF3002
Study First Received: November 4, 2009
Last Updated: May 17, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Salix Pharmaceuticals:
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

Additional relevant MeSH terms:
Ulcer
Proctitis
Proctocolitis
Pathologic Processes
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Rectal Diseases
Intestinal Diseases
Colitis
Colonic Diseases
Sigmoid Diseases
Budesonide
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Bronchodilator Agents
Autonomic Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on September 22, 2014