A Phase 2 interventional study of Dehydroepiandrosterone [DHEA] in Crohn's Disease, sponsored by Inflabloc Pharmaceuticals. Completed at 38 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2007-10-19.
Sponsored by Inflabloc Pharmaceuticals · Phase 2, Interventional, and Treatment
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.
1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.
This study's enrollment of 75 is above the median of 66 across 1,188 interventional studies indexed under Crohn Disease.
Browse Crohn Disease studies →This is the only study on the registry with Inflabloc Pharmaceuticals as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Achieving CDAI (Crohn's Disease Activity Index) of 150 or less after 8 weeks of treatment
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
This study is completed, as verified in Oct 2007. You cannot join it, but the record below documents what was studied.
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