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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01008410
Recruitment Status : Completed
First Posted : November 5, 2009
Last Update Posted : May 20, 2013
Information provided by (Responsible Party):
Valeant Pharmaceuticals International, Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Proctitis Proctosigmoiditis Drug: Budesonide Drug: Placebo Phase 3

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 265 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : November 2009
Actual Primary Completion Date : April 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Budesonide

Arm Intervention/treatment
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 QD for 4 weeks

Primary Outcome Measures :
  1. The proportion of subjects who achieve remission. [ Time Frame: 6 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01008410

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Sponsors and Collaborators
Valeant Pharmaceuticals International, Inc.

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Valeant Pharmaceuticals International, Inc. Identifier: NCT01008410     History of Changes
Other Study ID Numbers: BUCF3001
First Posted: November 5, 2009    Key Record Dates
Last Update Posted: May 20, 2013
Last Verified: November 2012

Keywords provided by Valeant Pharmaceuticals International, Inc.:
Budesonide foam
Additional relevant MeSH terms:
Colitis, Ulcerative
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:
Pathologic Processes
Gastrointestinal Diseases
Digestive System Diseases
Rectal Diseases
Intestinal Diseases
Colonic Diseases
Sigmoid Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents