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 Crohn''''s disease in adults.

Condition	Intervention	Phase
Crohn''''s Disease	Drug: Nitazoxanide	Phase II

Further Study Details: 

Primary Outcomes: Change in Crohn''''s Disease Activity Index (CDAI) from day baseline to day 14.
Secondary Outcomes: Clinical response; remission; change in C-reactive protein; reduction in steroid use; fistula response; change in Perianal Disease Activity Index (PDAI); change in plasma cytokine levels.
Expected Total Enrollment:  100

There is a significant need for a safe and effective treatment of Crohn’s disease. It is recognized that bacteria in the gut lumen may have a role in the etiology and/or symptoms of this disease. Antimicrobials have often been used in treating Crohn’s 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 Crohn’s disease.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Age ≥18 years.
• Diagnosis of Crohn''''s disease with colonic or perianal involvement confirmed by endoscopic, histologic and/or radiologic data.
• CDAI score ≥200 and ≤400.

Exclusion Criteria:

• Subjects known to have stool positive for Clostridium difficile toxin A or B, bacterial enteric pathogens, rotavirus, Cryptosporidium spp., and/or ova/parasites.
• Evidence of bowel obstruction.
• Females that are pregnant, breast-feeding or not using birth control and are sexually active.
• Serious systemic disorders incompatible with the study.
• History of hypersensitivity to nitazoxanide or any inactive ingredient in the formulation.
• Uncontrolled gastro-intestinal bleeding.
• Evidence of intestinal abscess, non-perianal fistula or stricture.
• Patients who have received antibiotics in the past 7 days.
• Patients receiving >20 mg of prednisone, or its equivalent.
• Patients receiving Anucort-HC or rectal steroids.
• Patients receiving immunosuppressive therapy that has not been stabilized.
• Patients who have received TNF-alpha inhibitor treatments such as infliximab or other biological agents within three months prior to start of treatment.
• Patients with Crohn''''s disease confined to the esophagus, stomach and small bowel.

Please refer to this study by ClinicalTrials.gov identifier  NCT00130390

George Camarinos, MD      813-282-8544    george.camarinos@romark.com
Heidi M Ano, BS      813-282-8544    heidi.ano@romark.com

Florida
      Romark Laboratories, L.C., Tampa,  Florida,  33607,  United States; Recruiting

Study chairs or principal investigators

George Camarinos, MD,  Study Director,  Romark Laboratories L.C.   

Study ID Numbers:  RM01-2018
Last Updated:  August 12, 2005
Record first received:  August 12, 2005
ClinicalTrials.gov Identifier:  NCT00130390
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-08-23