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

November 4, 2009
May 17, 2013
November 2009
March 2013   (final data collection date for primary outcome measure)
The proportion of subjects who achieve remission. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
The proportion of subjects who achieve remission. [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01008423 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Efficacy and Safety of Budesonide Foam for Patients With Active Mild to Moderate Ulcerative Proctitis or Proctosigmoiditis
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

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.

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

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Proctitis
  • Proctosigmoiditis
  • Drug: Budesonide
    2mg/25mL BID for 2 weeks followed by 2mg/25mL QD for 4 weeks
  • Drug: Placebo
    Placebo foam/25mL BID for 2 weeks followed by 2mg/25mL QD for 4 weeks
  • Experimental: Budesonide
    Budesonide rectal foam
    Intervention: Drug: Budesonide
  • Placebo Comparator: Placebo
    Placebo foam
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
281
Not Provided
March 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01008423
BUCF3002
No
Salix Pharmaceuticals
Salix Pharmaceuticals
Not Provided
Not Provided
Salix Pharmaceuticals
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP