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Safety and Efficacy of AST-120 in Mild to Moderate Crohn's Patients With Fistulas

NCT00321412 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 191

Last updated 2014-05-30

No results posted yet for this study

Summary

The objective of this study is to evaluate the safety and effectiveness of the experimental drug AST-120 in treating patients with mild to moderately severe Crohn's disease who have fistulas. The study will test whether or not patients receiving AST-120 experience a greater reduction in number of draining fistulas and improvement of their other Crohn's disease symptoms versus patients who receive placebo (material that does not contain any active medication).

Conditions

Interventions

DRUG

AST-120

oral, sachet, 2 grams three times daily for 8 weeks

Sponsors & Collaborators

  • Ocera Therapeutics

    lead INDUSTRY

Principal Investigators

  • Laurent Fischer, MD · Ocera Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-03-31
Primary Completion
2008-03-31
Completion
2008-09-30

Countries

  • United States
  • Austria
  • Belgium
  • Canada
  • Czechia
  • France
  • Germany
  • Hungary
  • Israel
  • Netherlands
  • Poland
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00321412 on ClinicalTrials.gov