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

Completed · Phase 2

Conditions studied: Crohn's Disease

In brief

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.

Key facts

Study ID

NCT00106314

Run by

Inflabloc Pharmaceuticals

People needed

75

Starts

2005-01-01

Expected to finish

2006-10-01

Last updated by the study team

2007-10-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Clinical Research Associates — Huntsville, Alabama, United States
• Advanced Clinical Research Institute — Anaheim, California, United States
• Sharp Rees-Stealy Medical Group — San Diego, California, United States
• Clinical Research of West Florida — Clearwater, Florida, United States
• Borland-Groover Clinic — Jacksonville, Florida, United States
• Atlanta Gastroenterology Associates — Atlanta, Georgia, United States
• Northwest Gastroenterologists — Arlington Heights, Illinois, United States
• The University of Chicago Hospital — Chicago, Illinois, United States
• University of Louisville, Department of Internal Medicine — Louisville, Kentucky, United States
• Ochsner Clinic Foundation — New Orleans, Louisiana, United States
• Maryland Clinical Trials — Severna Park, Maryland, United States
• Jason Bodzin, MD — Farmington Hills, Michigan, United States
• AGA Clinical Research Associates — Egg Harbor, New Jersey, United States
• New York Center for Clinical Research — Lake Success, New York, United States
• Charlotte Gastroenterology and Hepatology — Charlotte, North Carolina, United States
• Consultants for Clinical Research — Cincinnati, Ohio, United States
• The Cleveland Clinic Foundation, Dept. of Gastroenterology — Cleveland, Ohio, United States
• Penn State Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States
• Allegheny Center for Digestive Health — Pittsburgh, Pennsylvania, United States
• The Medical University of South Carolina — Charleston, South Carolina, United States
• Nashville Medical Research Institute — Nashville, Tennessee, United States
• Atilla Ertan, MD — Houston, Texas, United States
• Mountain West Gastroenterology — Salt Lake City, Utah, United States
• SMG Reseach — Salt Lake City, Utah, United States
• University of Vermont College of Medicine / Fletcher Allen Health Care — Burlington, Vermont, United States

Full record on ClinicalTrials.gov

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