Clinical trial NCT00130390: Study of Nitazoxanide Tablets in the Treatment of Mild to Moderate Active Crohn's Disease
Official title: Multi-center, Randomized, Double-Blind, Placebo-Controlled Trial of Nitazoxanide Tablets in the Treatment of Mild to Moderate Active Crohn's Disease in Adults
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Crohn's Disease
Keywords: Crohn's Disease
Lead sponsor: Romark Laboratories L.C.
Sponsor class: INDUSTRY
First posted: 2005-08-15
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 Crohn's disease in adults.

Detailed description: 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.

Eligibility 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 species (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.

Primary outcomes:
measure: Change in Crohn's Disease Activity Index (CDAI)
timeFrame: Day 14
Secondary outcomes:
measure: 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
timeFrame: Days 14 and 28
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Romark Laboratories, L.C.
state: Florida
city: Zephyrhills
country: United States
facility: Florida medical Clinic, P.A.
state: Florida
city: Marietta
country: United States
facility: Atlanta Gastroenterology
state: Georgia
city: Woodstock
country: United States
facility: Atlanta Gastroenterology
state: Georgia
city: Baton Rouge
country: United States
facility: Gasteroenterology Associates
state: Louisiana
city: Plymouth
country: United States
facility: Minnesota Gastroenterology, P.A., Clinical Research Division
state: Minnesota
city: Great Neck
country: United States
facility: Long Island Clinical Research Associates, LLP
state: New York
city: Cincinnati
country: United States
facility: Greater Cincinnati Gastroenterology Associates
state: Ohio
city: Mayfield Heights
country: United States
facility: Digestive Research & Infusion Institute
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma Foundation for Digestive Research
state: Oklahoma
city: Germantown
country: United States
facility: Memphis Gastroenterology Group
state: Tennessee
city: Kingsport
country: United States
facility: Gastrointestinal Associates, LLC
state: Tennessee
city: Nashville
country: United States
facility: Nashville Medical Research
state: Tennessee
Study officials:
affiliation: Romark Laboratories L.C.
name: Maria Carrion, MD
role: STUDY_DIRECTOR
References: