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
1 other identifier
interventional
75
2 countries
38
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jan 2005
38 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2005
CompletedFirst Submitted
Initial submission to the registry
March 22, 2005
CompletedFirst Posted
Study publicly available on registry
March 23, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2006
CompletedOctober 19, 2007
October 1, 2007
March 22, 2005
October 17, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Achieving CDAI (Crohn's Disease Activity Index) of 150 or less after 8 weeks of treatment
Secondary Outcomes (5)
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
Interventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (38)
Clinical Research Associates
Huntsville, Alabama, 35801, United States
Advanced Clinical Research Institute
Anaheim, California, 92801, United States
Sharp Rees-Stealy Medical Group
San Diego, California, 92123, United States
Clinical Research of West Florida
Clearwater, Florida, 33765, United States
Borland-Groover Clinic
Jacksonville, Florida, 32256, United States
Atlanta Gastroenterology Associates
Atlanta, Georgia, 30342, United States
Northwest Gastroenterologists
Arlington Heights, Illinois, 60005, United States
The University of Chicago Hospital
Chicago, Illinois, 60637, United States
University of Louisville, Department of Internal Medicine
Louisville, Kentucky, 40202, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121, United States
Maryland Clinical Trials
Severna Park, Maryland, 21146, United States
Jason Bodzin, MD
Farmington Hills, Michigan, 43884, United States
AGA Clinical Research Associates
Egg Harbor, New Jersey, 08234, United States
New York Center for Clinical Research
Lake Success, New York, 11042, United States
Charlotte Gastroenterology and Hepatology
Charlotte, North Carolina, 28207, United States
Consultants for Clinical Research
Cincinnati, Ohio, 45219, United States
The Cleveland Clinic Foundation, Dept. of Gastroenterology
Cleveland, Ohio, 44195, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Allegheny Center for Digestive Health
Pittsburgh, Pennsylvania, 15212, United States
The Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Nashville Medical Research Institute
Nashville, Tennessee, 37205, United States
Atilla Ertan, MD
Houston, Texas, 77030, United States
Mountain West Gastroenterology
Salt Lake City, Utah, 84121, United States
SMG Reseach
Salt Lake City, Utah, 84124, United States
University of Vermont College of Medicine / Fletcher Allen Health Care
Burlington, Vermont, 05403, United States
McGuire DVAMC GI (111N)
Richmond, Virginia, 23249, United States
University of Washington Medical Center, Department of Gastroenterology
Seattle, Washington, 98195, United States
Tacoma Digestive Disease Research Center
Tacoma, Washington, 98405, United States
Wisconsin Center for Advanced Research
Milwaukee, Wisconsin, 53215, United States
GILDR Group
Edmonton, Alberta, T6G 2X8, Canada
Gastrointestinal Research Institute
Vancouver, British Columbia, V6Z 2K5, Canada
Alan Cockeram, MD
Saint John, New Brunswick, E2K 1J5, Canada
IBD Clinical and Research Centre
Winnipeg, New Brunswick, R3A 1R9, Canada
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, B3H 1V7, Canada
Doug Hemphill, MD
Barrie, Ontario, L4M 5G1, Canada
Credit Valley Digestive Disease Group
Mississauga, Ontario, L5M 2V8, Canada
Philip Hassard, MD
Ottawa, Ontario, K1K 4L2, Canada
Saskatoon Medical Specialists
Saskatoon, Saskatchewan, S7K 1N4, Canada
Related Publications (1)
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.
PMID: 12562454BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Paul A. Litka, MD
Inflabloc Pharmaceuticals, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 22, 2005
First Posted
March 23, 2005
Study Start
January 1, 2005
Study Completion
October 1, 2006
Last Updated
October 19, 2007
Record last verified: 2007-10