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High Dose Oral 4-Aminosalicylic Acid (PASER®) to Control Acute Flares of Mild to Moderate Crohn's Disease

NCT00417690 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2008-10-15

No results posted yet for this study

Summary

The purpose of this 4 week study is to determine whether PASER®, an approved delayed-release oral formulation of 4-aminosalicylic acid, in doses of 4 grams three times daily for 2 weeks followed by 4 grams twice daily for 2 weeks, will resolve an acute flare of ileocecal Crohn's disease.

Conditions

Interventions

DRUG

4-Aminosalicylic acid

Oral granules administered as one 4 g packet three times daily for two weeks followed by one 4 g packet two times daily for two weeks

DRUG

PASER placebo granules

Oral granules administered administered as one packet three times daily for two weeks followed by one packet two times daily for two weeks

Sponsors & Collaborators

  • Jacobus Pharmaceutical

    lead INDUSTRY

Principal Investigators

  • David P. Jacobus, MD · Jacobus Pharmaceutical

  • Kathy L. Ales, MD · Jacobus Pharmaceutical

  • Daniel Present, MD · Icahn School of Medicine at Mount Sinai

  • Stephen B. Hanauer, MD · University of Chicago Hospitals

  • John Hanson, MD · Charlotte Gastroenterology & Hepatology, PLLC

  • Iris Dotan, MD · Tel-Aviv Sourasky Medical Center

  • Rami Eliakim, MD · Rambam Health Care Campus

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2007-12-31
Completion
2008-10-31

Countries

  • United States
  • Israel

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 NCT00417690 on ClinicalTrials.gov