Clinical trial NCT00106314: An Efficacy and Safety Evaluation of Inflabloc Cap in the Treatment of Patients With Crohn's Disease
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Crohn's Disease
Keywords: Dehydroepiandrosterone
DHEA
Crohn's disease
C-reactive protein
CRP
Crohn's Disease Activity Index
CDAI
Inflammatory Bowel Disease Questionnaire
IBDQ
Lead sponsor: Inflabloc Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2005-03-23
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
measure: Achieving CDAI (Crohn's Disease Activity Index) of 150 or less after 8 weeks of treatment
Secondary outcomes:
measure: Achieving a CDAI score of 150 or less at 4 weeks
measure: Change in CDAI from baseline of at least 100 points at 4 and 8 weeks
measure: Change in CRP (C-Reactive Protein) from baseline at 4 and 8 weeks
measure: Change in health-related quality of life from baseline at 8 weeks as measured by the Inflammatory Bowel Disease Questionnaire (IBDQ)
measure: Change from baseline in diarrhea and abdominal pain sub-scores from CDAI
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Clinical Research Associates
state: Alabama
city: Anaheim
country: United States
facility: Advanced Clinical Research Institute
state: California
city: San Diego
country: United States
facility: Sharp Rees-Stealy Medical Group
state: California
city: Clearwater
country: United States
facility: Clinical Research of West Florida
state: Florida
city: Jacksonville
country: United States
facility: Borland-Groover Clinic
state: Florida
city: Atlanta
country: United States
facility: Atlanta Gastroenterology Associates
state: Georgia
city: Arlington Heights
country: United States
facility: Northwest Gastroenterologists
state: Illinois
city: Chicago
country: United States
facility: The University of Chicago Hospital
state: Illinois
city: Louisville
country: United States
facility: University of Louisville, Department of Internal Medicine
state: Kentucky
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Severna Park
country: United States
facility: Maryland Clinical Trials
state: Maryland
city: Farmington Hills
country: United States
facility: Jason Bodzin, MD
state: Michigan
city: Egg Harbor Township
country: United States
facility: AGA Clinical Research Associates
state: New Jersey
city: Lake Success
country: United States
facility: New York Center for Clinical Research
state: New York
city: Charlotte
country: United States
facility: Charlotte Gastroenterology and Hepatology
state: North Carolina
city: Cincinnati
country: United States
facility: Consultants for Clinical Research
state: Ohio
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation, Dept. of Gastroenterology
state: Ohio
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny Center for Digestive Health
state: Pennsylvania
city: Charleston
country: United States
facility: The Medical University of South Carolina
state: South Carolina
city: Nashville
country: United States
facility: Nashville Medical Research Institute
state: Tennessee
city: Houston
country: United States
facility: Atilla Ertan, MD
state: Texas
city: Salt Lake City
country: United States
facility: Mountain West Gastroenterology
state: Utah
city: Salt Lake City
country: United States
facility: SMG Reseach
state: Utah
city: Burlington
country: United States
facility: University of Vermont College of Medicine / Fletcher Allen Health Care
state: Vermont
city: Richmond
country: United States
facility: McGuire DVAMC GI (111N)
state: Virginia
city: Seattle
country: United States
facility: University of Washington Medical Center, Department of Gastroenterology
state: Washington
city: Tacoma
country: United States
facility: Tacoma Digestive Disease Research Center
state: Washington
city: Milwaukee
country: United States
facility: Wisconsin Center for Advanced Research
state: Wisconsin
city: Edmonton
country: Canada
facility: GILDR Group
state: Alberta
city: Vancouver
country: Canada
facility: Gastrointestinal Research Institute
state: British Columbia
city: Saint John
country: Canada
facility: Alan Cockeram, MD
state: New Brunswick
city: Winnipeg
country: Canada
facility: IBD Clinical and Research Centre
state: New Brunswick
city: Halifax
country: Canada
facility: Queen Elizabeth II Health Sciences Centre
state: Nova Scotia
city: Barrie
country: Canada
facility: Doug Hemphill, MD
state: Ontario
city: Mississauga
country: Canada
facility: Credit Valley Digestive Disease Group
state: Ontario
city: Ottawa
country: Canada
facility: Philip Hassard, MD
state: Ontario
city: Saskatoon
country: Canada
facility: Saskatoon Medical Specialists
state: Saskatchewan
Study officials:
affiliation: Inflabloc Pharmaceuticals, Inc.
name: Paul A. Litka, MD
role: STUDY_DIRECTOR
References:
citation: 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.