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