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

This study has been completed.
Sponsor:
Information provided by:
Inflabloc Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00106314
First received: March 22, 2005
Last updated: October 17, 2007
Last verified: October 2007
  Purpose

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 Intervention Phase
Crohn's Disease
Drug: Dehydroepiandrosterone [DHEA]
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Inflabloc Pharmaceuticals:

Primary Outcome Measures:
  • Achieving CDAI (Crohn's Disease Activity Index) of 150 or less after 8 weeks of treatment

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 75
Study Start Date: January 2005
Study Completion Date: October 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00106314

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

Publications:
ClinicalTrials.gov Identifier: NCT00106314     History of Changes
Other Study ID Numbers: CL-C002-00
Study First Received: March 22, 2005
Last Updated: October 17, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Inflabloc Pharmaceuticals:
Dehydroepiandrosterone
DHEA
Crohn's disease
C-reactive protein
CRP
Crohn's Disease Activity Index
CDAI
Inflammatory Bowel Disease Questionnaire
IBDQ

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Dehydroepiandrosterone
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014