An Efficacy and Safety Evaluation of Inflabloc Cap in the Treatment of Patients With Crohn's Disease
NCT ID: NCT00106314
Last Updated: 2007-10-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
75 participants
INTERVENTIONAL
2005-01-31
2006-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Dehydroepiandrosterone [DHEA]
Eligibility Criteria
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Inclusion Criteria
* C-reactive protein above the upper limit of normal.
* Currently have moderately active Crohn's disease.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Inflabloc Pharmaceuticals
INDUSTRY
Principal Investigators
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Paul A. Litka, MD
Role: STUDY_DIRECTOR
Inflabloc Pharmaceuticals, Inc.
Locations
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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
McGuire DVAMC GI (111N)
Richmond, Virginia, United States
University of Washington Medical Center, Department of Gastroenterology
Seattle, Washington, United States
Tacoma Digestive Disease Research Center
Tacoma, Washington, United States
Wisconsin Center for Advanced Research
Milwaukee, Wisconsin, United States
GILDR Group
Edmonton, Alberta, Canada
Gastrointestinal Research Institute
Vancouver, British Columbia, Canada
Alan Cockeram, MD
Saint John, New Brunswick, Canada
IBD Clinical and Research Centre
Winnipeg, New Brunswick, Canada
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, Canada
Doug Hemphill, MD
Barrie, Ontario, Canada
Credit Valley Digestive Disease Group
Mississauga, Ontario, Canada
Philip Hassard, MD
Ottawa, Ontario, Canada
Saskatoon Medical Specialists
Saskatoon, Saskatchewan, Canada
Countries
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References
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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.
Other Identifiers
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CL-C002-00
Identifier Type: -
Identifier Source: org_study_id