Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00106314
Status:
COMPLETED
Last Update Posted:
2007-10-19
First Post:
2005-03-22
Brief Title:
An Efficacy and Safety Evaluation of Inflabloc Cap in the Treatment of Patients With Crohns Disease
Sponsor:
Inflabloc Pharmaceuticals
Organization:
Inflabloc Pharmaceuticals
Study Overview
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 Crohns Disease
Status:
COMPLETED
Status Verified Date:
2007-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Crohns 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 Crohns 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 Crohns 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 111 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 dosesday 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 Crohns disease with elevated CRP will be monitored through clinical evaluation clinical laboratory data collection of Adverse Events and other relevant safety evaluations
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 111 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 dosesday 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 Crohns disease with elevated CRP will be monitored through clinical evaluation clinical laboratory data collection of Adverse Events and other relevant safety evaluations
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None