MedTrace Logo

Open-Label, Long-term Balsalziade Disodium Tablet Ulcerative Colitis Study

NCT00486031 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 443

Last updated 2019-08-15

Study results available
· View outcomes & findings →

Summary

The objective of the study is to evaluate the long-term safety and tolerability of treatment with balsalazide disodium tablets in subjects who are in remission from ulcerative colitis or who have mildly to moderately active UC.

Conditions

Interventions

DRUG

Balsalazide Disodium

Sponsors & Collaborators

  • Bausch Health Americas, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2008-04-30
Completion
2008-12-31

Countries

  • United States

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 NCT00486031 on ClinicalTrials.gov