NCT00130390

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2005

Typical duration for phase_2

Geographic Reach
1 country

13 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

August 12, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 15, 2005

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

May 31, 2012

Status Verified

May 1, 2012

Enrollment Period

2.3 years

First QC Date

August 12, 2005

Last Update Submit

May 30, 2012

Conditions

Crohn's Disease

Keywords

Crohn's Disease

Outcome Measures

Primary Outcomes (1)

  • Change in Crohn's Disease Activity Index (CDAI)

    Day 14

Secondary Outcomes (1)

  • 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

    Days 14 and 28

Study Arms (2)

1

EXPERIMENTAL

One nitazoxanide 500 mg tablet twice daily for 28 days

Drug: Nitazoxanide

2

PLACEBO COMPARATOR

One placebo tablet twice daily for 28 days

Other: Placebo

Interventions

NitazoxanideDRUG

One nitazoxanide 500 mg tablet twice daily for 28 days

Also known as: Alinia
1
PlaceboOTHER

One placebo tablet twice daily for 28 days

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Romark Laboratories, L.C.

Tampa, Florida, 33607, United States

Location

Florida medical Clinic, P.A.

Zephyrhills, Florida, 33542, United States

Location

Atlanta Gastroenterology

Marietta, Georgia, 30067, United States

Location

Atlanta Gastroenterology

Woodstock, Georgia, 30189, United States

Location

Gasteroenterology Associates

Baton Rouge, Louisiana, 70809, United States

Location

Minnesota Gastroenterology, P.A., Clinical Research Division

Plymouth, Minnesota, 55446, United States

Location

Long Island Clinical Research Associates, LLP

Great Neck, New York, 11021, United States

Location

Greater Cincinnati Gastroenterology Associates

Cincinnati, Ohio, 45219, United States

Location

Digestive Research & Infusion Institute

Mayfield Heights, Ohio, 44124, United States

Location

Oklahoma Foundation for Digestive Research

Oklahoma City, Oklahoma, 73104, United States

Location

Memphis Gastroenterology Group

Germantown, Tennessee, 38138, United States

Location

Gastrointestinal Associates, LLC

Kingsport, Tennessee, 37660, United States

Location

Nashville Medical Research

Nashville, Tennessee, 37205, United States

Location

MeSH Terms

Conditions

Crohn Disease

Interventions

nitazoxanide

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Officials

  • Maria Carrion, MD

    Romark Laboratories L.C.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2005

First Posted

August 15, 2005

Study Start

August 1, 2005

Primary Completion

December 1, 2007

Study Completion

July 1, 2008

Last Updated

May 31, 2012

Record last verified: 2012-05

Locations

US(13)