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Study of COLAL-PRED to Treat Moderate to Severe Ulcerative Colitis

NCT00676832 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 190

Last updated 2010-09-29

No results posted yet for this study

Summary

The purpose of this study is to determine whether COLAL-PRED is a safe and effective treatment for patients with moderate to severe ulcerative colitis.

Conditions

  • Colitis, Ulcerative

Interventions

DRUG

Placebo

Placebo solid capsule dosage form administered orally once daily.

DRUG

COLAL-PRED

The study is a double-blinded and results have not been unblinded. Patients were randomized to one of four doses. A solid capsule dosage form was administered orally once daily at doses of 40 mg, 60 mg, 80 mg, or 120 mg.

Sponsors & Collaborators

  • Prometheus Laboratories

    lead INDUSTRY

Principal Investigators

  • David T. Rubin, M.D. · The University of Chicago Hospitals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2009-10-31
Completion
2009-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT00676832 on ClinicalTrials.gov