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NCT00269438 · ClinicalTrials.gov registry record · Phase 3

New Tablet Formulation and Dosing Regimen of Balsalazide Disodium in Mildly to Moderately Active Ulcerative Colitis

A Phase 3 study, sponsored by Bausch Health Americas.

Completed
Registry status
Phase 3
Development phase
225
Enrollment target

NCT00269438 is a Phase 3 study that has completed, run by Bausch Health Americas. The registered enrollment target is 225 participants.

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The verdict

NCT00269438, a Phase 3 study, has completed, sponsored by Bausch Health Americas.

COMPLETED
Registry status
Phase 3
Development phase
225 participants
Enrollment target

Study Summary

The purpose of this study is to establish the efficacy and safety of a new tablet formulation and dosing regimen of balsalazide disodium dosed twice daily in achieving clinical improvement in subjects with mildly to moderately active ulcerative colitis after 8 weeks of therapy.

Interventions

  • DRUG 5 ASA, enemas, suppositories, corticosteroids

Trial Details

FieldValue
Enrollment Target 225 participants
Start Date 2005-12
Est. Completion 2007-06
Phase Phase 3

Sponsor

Bausch Health Americas

168 total trials

What the Registry Record Tells You About NCT00269438

The ClinicalTrials.gov registry entry for NCT00269438 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 225 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bausch Health Americas, which has 168 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which 5 ASA, enemas, suppositories, corticosteroids is the first listed.

NCT00269438 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00269438 about?

NCT00269438 is a clinical study titled "New Tablet Formulation and Dosing Regimen of Balsalazide Disodium in Mildly to Moderately Active Ulcerative Colitis". The purpose of this study is to establish the efficacy and safety of a new tablet formulation and dosing regimen of balsalazide disodium dosed twice daily in achieving clinical improvement in subjects with mildly to moderately active ulcerative colitis after 8 weeks of therapy.

What is the current status of trial NCT00269438?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 225 participants. The study started on 2005-12. Estimated completion is 2007-06.

What interventions are being tested in trial NCT00269438?

The interventions under investigation include: 5 ASA, enemas, suppositories, corticosteroids (DRUG).

Who is sponsoring clinical trial NCT00269438?

This trial is sponsored by Bausch Health Americas, which has 168 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.