Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00130390
Status:
TERMINATED
Last Update Posted:
2012-05-31
First Post:
2005-08-12
Brief Title:
Study of Nitazoxanide Tablets in the Treatment of Mild to Moderate Active Crohns Disease
Sponsor:
Romark Laboratories LC
Organization:
Romark Laboratories LC
Study Overview
Official Title:
Multi-center Randomized Double-Blind Placebo-Controlled Trial of Nitazoxanide Tablets in the Treatment of Mild to Moderate Active Crohns Disease in Adults
Status:
TERMINATED
Status Verified Date:
2012-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
terminated due to slow recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective of this study is to evaluate the efficacy and safety of nitazoxanide compared to a placebo in reducing the signs and symptoms of mild to moderate active Crohns disease in adults
Detailed Description:
There is a significant need for a safe and effective treatment of Crohns disease It is recognized that bacteria in the gut lumen may have a role in the etiology andor symptoms of this disease Antimicrobials have often been used in treating Crohns disease although their effectiveness has not been well established Pro-inflammatory cytokines are also believed to play an important role in this disease Nitazoxanide a thiazolide anti-infective is active in vitro against a broad spectrum of anaerobic bacteria and it inhibits secretion of pro-inflammatory cytokines including IL-2 -4 -5 -6 -8 -10 and TNF alpha The drug is also highly concentrated in the gastrointestinal tract With these characteristics nitazoxanide offers a unique approach to treatment of Crohns disease
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