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.

Condition	Treatment or Intervention	Phase
Crohn's Disease	Drug: Dehydroepiandrosterone [DHEA]	Phase II

Further Study Details: 

Primary Outcomes: Achieving CDAI (Crohn's Disease Activity Index) of 150 or less after 8 weeks of treatment
Secondary Outcomes: 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
Expected Total Enrollment:  75

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

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.

Claire A. Daugherty, MS      801-464-6107    cdaugherty@inflabloc.com
Paul A. Litka, MD      801-464-6107    plitka@inflabloc.com

Alabama
      Clinical Research Associates, Huntsville,  Alabama,  35801,  United States; Recruiting
California
      Digestive Diseases Foundation, Los Angeles,  California,  90067,  United States; Recruiting
      Sharp Rees-Stealy Medical Group, San Diego,  California,  92123,  United States; Recruiting
Florida
      Venture Research, North Miami,  Florida,  33162,  United States; Recruiting
      Medical Research Unlimited, Hialeah,  Florida,  33013,  United States; Recruiting
      Clinical Research of West Florida, Clearwater,  Florida,  33765,  United States; Recruiting
Illinois
      Northwest Gastroenterologists, Arlington Heights,  Illinois,  60005,  United States; Recruiting
Maryland
      Maryland Clinical Trials, Severna Park,  Maryland,  21146,  United States; Recruiting
Massachusetts
      Clinical Pharmacology Study Group, Worcester,  Massachusetts,  01610,  United States; Recruiting
North Carolina
      Charlotte Gastroenterology and Hepatology, Charlotte,  North Carolina,  28207,  United States; Recruiting
Ohio
      Consultants for Clinical Research, Cincinnati,  Ohio,  45219,  United States; Recruiting
Tennessee
      Gastrointestinal Associates, Knoxville,  Tennessee,  37909,  United States; Recruiting
      Nashville Medical Research Institute, Nashville,  Tennessee,  37205,  United States; Recruiting
Texas
      Gastroenterology Clinic of San Antonio, San Antonio,  Texas,  78229-3436,  United States; Recruiting
Vermont
      University of Vermont College of Medicine / Fletcher Allen Health Care, Burlington,  Vermont,  05403,  United States; Recruiting
Wisconsin
      Wisconsin Center for Advanced Research, Milwaukee,  Wisconsin,  53215,  United States; Recruiting

Study chairs or principal investigators

Paul A. Litka, MD,  Study Director,  Inflabloc Pharmaceuticals, Inc.   

Study ID Numbers:  CL-C002-00
Record last reviewed:  March 2005
Last Updated:  April 1, 2005
Record first received:  March 22, 2005
ClinicalTrials.gov Identifier:  NCT00106314
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08