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

Crohn's Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00106314
• Other study ID #: CL-C002-00
• Status: Completed
• Phase: Phase 2
• First received: March 22, 2005
• Last updated: October 17, 2007
• Start date: January 2005
• Est. completion date: October 2006

Study information

• Verified date: October 2007
• Source: Inflabloc Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Drug:
• Dehydroepiandrosterone [DHEA]

Locations

Country	Name	City	State
Canada	Doug Hemphill, MD	Barrie	Ontario
Canada	GILDR Group	Edmonton	Alberta
Canada	Queen Elizabeth II Health Sciences Centre	Halifax	Nova Scotia
Canada	Credit Valley Digestive Disease Group	Mississauga	Ontario
Canada	Philip Hassard, MD	Ottawa	Ontario
Canada	Alan Cockeram, MD	Saint John	New Brunswick
Canada	Saskatoon Medical Specialists	Saskatoon	Saskatchewan
Canada	Gastrointestinal Research Institute	Vancouver	British Columbia
Canada	IBD Clinical and Research Centre	Winnipeg	New Brunswick
United States	Advanced Clinical Research Institute	Anaheim	California
United States	Northwest Gastroenterologists	Arlington Heights	Illinois
United States	Atlanta Gastroenterology Associates	Atlanta	Georgia
United States	University of Vermont College of Medicine / Fletcher Allen Health Care	Burlington	Vermont
United States	The Medical University of South Carolina	Charleston	South Carolina
United States	Charlotte Gastroenterology and Hepatology	Charlotte	North Carolina
United States	The University of Chicago Hospital	Chicago	Illinois
United States	Consultants for Clinical Research	Cincinnati	Ohio
United States	Clinical Research of West Florida	Clearwater	Florida
United States	The Cleveland Clinic Foundation, Dept. of Gastroenterology	Cleveland	Ohio
United States	AGA Clinical Research Associates	Egg Harbor Township	New Jersey
United States	Jason Bodzin, MD	Farmington Hills	Michigan
United States	Penn State Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	Atilla Ertan, MD	Houston	Texas
United States	Clinical Research Associates	Huntsville	Alabama
United States	Borland-Groover Clinic	Jacksonville	Florida
United States	New York Center for Clinical Research	Lake Success	New York
United States	University of Louisville, Department of Internal Medicine	Louisville	Kentucky
United States	Wisconsin Center for Advanced Research	Milwaukee	Wisconsin
United States	Nashville Medical Research Institute	Nashville	Tennessee
United States	Ochsner Clinic Foundation	New Orleans	Louisiana
United States	Allegheny Center for Digestive Health	Pittsburgh	Pennsylvania
United States	McGuire DVAMC GI (111N)	Richmond	Virginia
United States	Mountain West Gastroenterology	Salt Lake City	Utah
United States	SMG Reseach	Salt Lake City	Utah
United States	Sharp Rees-Stealy Medical Group	San Diego	California
United States	University of Washington Medical Center, Department of Gastroenterology	Seattle	Washington
United States	Maryland Clinical Trials	Severna Park	Maryland
United States	Tacoma Digestive Disease Research Center	Tacoma	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Inflabloc Pharmaceuticals

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (1)

Andus T, Klebl F, Rogler G, Bregenzer N, Schölmerich 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Achieving CDAI (Crohn's Disease Activity Index) of 150 or less after 8 weeks of treatment
Secondary	Achieving a CDAI score of 150 or less at 4 weeks
Secondary	Change in CDAI from baseline of at least 100 points at 4 and 8 weeks
Secondary	Change in CRP (C-Reactive Protein) from baseline at 4 and 8 weeks
Secondary	Change in health-related quality of life from baseline at 8 weeks as measured by the Inflammatory Bowel Disease Questionnaire (IBDQ)
Secondary	Change from baseline in diarrhea and abdominal pain sub-scores from CDAI