An Efficacy and Safety Evaluation of Inflabloc Cap in the Treatment of Patients With Crohn's Disease

A Randomized, Double-Blind, Multi-Center, Dose Response, Efficacy and Safety Evaluation of Inflabloc Cap in the Treatment of Patients With Moderately Active Crohn's Disease

The purpose of this study is to evaluate the efficacy and safety of Inflabloc Cap (Dehydroepiandrosterone [DHEA]) in the treatment of patients with moderately active Crohn's disease.

Study Overview

• Status: Completed
• Conditions: Crohn's Disease
• Intervention / Treatment: Drug: Dehydroepiandrosterone [DHEA]

Detailed Description

This is a randomized, double-blind, multi-center, dose response, efficacy and safety study of Inflabloc Cap in patients with moderately active Crohn's disease. The primary objectives of the study are to evaluate the efficacy and safety of Inflabloc Cap in the treatment of patients with moderately active Crohn's disease who also have elevated CRP.

The study will be conducted at approximately 20 centers. Each patient will undergo screening followed by 8 weeks of treatment with Inflabloc Cap. Eligible male and female patients will be randomized in a 1:1:1 ratio to placebo, 30 mg, or 60 mg of DHEA administered twice daily via Inflabloc Cap so that approximately 60 patients complete the study. Following the Screening evaluations, consenting patients will self-administer 2 doses/day of study medication (placebo, 30 mg, or 60 mg of DHEA via Inflabloc Cap) for a total of 8 weeks (approximately 56 days). Patients will be required to complete a daily diary containing evaluations for number of liquid and soft stools, abdominal pain, fever and general well-being. Patients will also record use of study drug, concomitant medications and adverse events on the daily diary. Patients will be required to visit the study center at Screening, Baseline and at Weeks 1, 2, 4 and 8 following the initiation of treatment to turn in their diaries and any unused study medication, receive a physical exam and submit blood samples for chemistry, hematology and specialty laboratory measurements, and a urine sample for urinalysis. A stool sample is also required at Screening for culture and assay for C. difficile toxin. In addition, at the 8-week visit, patients will receive an exit exam including a physical exam (with ECG and vitals) and submit blood samples for chemistry, hematology and specialty laboratory measurements and a urine sample for urinalysis.

The primary efficacy endpoint for this study is defined as achieving a CDAI of 150 or less after 8 weeks of treatment. Secondary and exploratory efficacy endpoints at Weeks 4 and 8 will include achieving a CDAI of 150 or less (at 4 weeks), a change in CDAI from baseline of at least 100 points, a change from baseline in CRP, change from baseline in diarrhea and abdominal pain sub-scores, and change from baseline in IBDQ. Additionally, the safety of Inflabloc Cap when administered to patients with moderately active Crohn's disease with elevated CRP will be monitored through clinical evaluation, clinical laboratory data, collection of Adverse Events and other relevant safety evaluations.

• Study Type: Interventional
• Enrollment: 75
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2X8
      • GILDR Group
  • British Columbia
    • Vancouver, British Columbia, Canada, V6Z 2K5
      • Gastrointestinal Research Institute
  • New Brunswick
    • Saint John, New Brunswick, Canada, E2K 1J5
      • Alan Cockeram, MD
    • Winnipeg, New Brunswick, Canada, R3A 1R9
      • IBD Clinical and Research centre
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 1V7
      • Queen Elizabeth II Health Sciences Centre
  • Ontario
    • Barrie, Ontario, Canada, L4M 5G1
      • Doug Hemphill, MD
    • Mississauga, Ontario, Canada, L5M 2V8
      • Credit Valley Digestive Disease Group
    • Ottawa, Ontario, Canada, K1K 4L2
      • Philip Hassard, MD
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7K 1N4
      • Saskatoon Medical Specialists
• United States
  • Alabama
    • Huntsville, Alabama, United States, 35801
      • Clinical Research Associates
  • California
    • Anaheim, California, United States, 92801
      • Advanced Clinical Research Institute
    • San Diego, California, United States, 92123
      • Sharp Rees-Stealy Medical Group
  • Florida
    • Clearwater, Florida, United States, 33765
      • Clinical Research of West Florida
    • Jacksonville, Florida, United States, 32256
      • Borland-Groover Clinic
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Atlanta Gastroenterology Associates
  • Illinois
    • Arlington Heights, Illinois, United States, 60005
      • Northwest Gastroenterologists
    • Chicago, Illinois, United States, 60637
      • The University of Chicago Hospital
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • University of Louisville, Department of Internal Medicine
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Ochsner Clinic Foundation
  • Maryland
    • Severna Park, Maryland, United States, 21146
      • Maryland Clinical Trials
  • Michigan
    • Farmington Hills, Michigan, United States, 43884
      • Jason Bodzin, MD
  • New Jersey
    • Egg Harbor Township, New Jersey, United States, 08234
      • AGA Clinical Research Associates
  • New York
    • Lake Success, New York, United States, 11042
      • New York Center for Clinical Research
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • Charlotte Gastroenterology and Hepatology
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Consultants for Clinical Research
    • Cleveland, Ohio, United States, 44195
      • The Cleveland Clinic Foundation, Dept. of Gastroenterology
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Milton S. Hershey Medical Center
    • Pittsburgh, Pennsylvania, United States, 15212
      • Allegheny Center for Digestive Health
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • The Medical University of South Carolina
  • Tennessee
    • Nashville, Tennessee, United States, 37205
      • Nashville Medical Research Institute
  • Texas
    • Houston, Texas, United States, 77030
      • Atilla Ertan, MD
  • Utah
    • Salt Lake City, Utah, United States, 84121
      • Mountain West Gastroenterology
    • Salt Lake City, Utah, United States, 84124
      • SMG Reseach
  • Vermont
    • Burlington, Vermont, United States, 05403
      • University of Vermont College of Medicine / Fletcher Allen Health Care
  • Virginia
    • Richmond, Virginia, United States, 23249
      • McGuire DVAMC GI (111N)
  • Washington
    • Seattle, Washington, United States, 98195
      • University of Washington Medical Center, Department of Gastroenterology
    • Tacoma, Washington, United States, 98405
      • Tacoma Digestive Disease Research Center
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53215
      • Wisconsin Center for Advanced Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Diagnosis of Crohn's disease made at least 3 months prior to study entry.
• C-reactive protein above the upper limit of normal.
• Currently have moderately active Crohn's disease.

Exclusion Criteria:

• Women who are pregnant or lactating or of childbearing potential.
• History of colostomy, ileostomy, intestinal resection resulting in short bowel syndrome or symptomatic strictures.
• Symptoms (abdominal pain, vomiting) and radiographic evidence of mechanical bowel obstruction within the previous 6 months.
• Fistulizing disease.
• Positive stool culture for enteric pathogens and/or C. difficile toxin.
• History of significant disease.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Achieving CDAI (Crohn's Disease Activity Index) of 150 or less after 8 weeks of treatment

Secondary Outcome Measures

Outcome Measure
Achieving a CDAI score of 150 or less at 4 weeks
Change in CDAI from baseline of at least 100 points at 4 and 8 weeks
Change in CRP (C-Reactive Protein) from baseline at 4 and 8 weeks
Change in health-related quality of life from baseline at 8 weeks as measured by the Inflammatory Bowel Disease Questionnaire (IBDQ)
Change from baseline in diarrhea and abdominal pain sub-scores from CDAI

Collaborators and Investigators

• Sponsor: Inflabloc Pharmaceuticals
• Investigators: Study Director: Paul A. Litka, MD, Inflabloc Pharmaceuticals, Inc.

Publications and helpful links

General Publications

• Andus T, Klebl F, Rogler G, Bregenzer N, Scholmerich J, Straub RH. Patients with refractory Crohn's disease or ulcerative colitis respond to dehydroepiandrosterone: a pilot study. Aliment Pharmacol Ther. 2003 Feb;17(3):409-14. doi: 10.1046/j.1365-2036.2003.01433.x.

Study record dates

Study Major Dates

• Study Start: January 1, 2005
• Study Completion (Actual): October 1, 2006

Study Registration Dates

• First Submitted: March 22, 2005
• First Submitted That Met QC Criteria: March 22, 2005
• First Posted (Estimate): March 23, 2005

Study Record Updates

• Last Update Posted (Estimate): October 19, 2007
• Last Update Submitted That Met QC Criteria: October 17, 2007
• Last Verified: October 1, 2007

More Information

Terms related to this study

• Keywords: Dehydroepiandrosterone; DHEA; Crohn's disease; C-reactive protein; CRP; Inflammatory Bowel Disease Questionnaire; Crohn's Disease Activity Index; CDAI; IBDQ
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease; Physiological Effects of Drugs; Immunologic Factors; Adjuvants, Immunologic; Dehydroepiandrosterone
• Other Study ID Numbers: CL-C002-00