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NCT00408174 · ClinicalTrials.gov registry record · Phase 3

Balsalazide Disodium vs. Mesalamine in Mildly to Moderately Active Ulcerative Colitis

A Phase 3 study, sponsored by Bausch Health Americas.

Completed
Registry status
Phase 3
Development phase
400
Enrollment target

NCT00408174: Completed Phase 3 study, sponsored by Bausch Health Americas.

NCT00408174 is a Phase 3 study that has completed, run by Bausch Health Americas. The registered enrollment target is 400 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (48% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00408174, a Phase 3 study, has completed, sponsored by Bausch Health Americas.

COMPLETED
Registry status
Phase 3
Development phase
400 participants
Enrollment target

Study Summary

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 6 weeks of therapy.

Interventions

  • DRUG Balsalazide disodium

Trial Details

FieldValue
Enrollment Target 400 participants
Start Date 2006-05
Est. Completion 2007-11
Phase Phase 3
Bausch Health Americas

168 total trials

What the finished NCT00408174 record still lists

NCT00408174 is an interventional study that assigns participants to a tested intervention. The registered 400 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (48% lower).

The record links to 0 conditions, and to 1 intervention - of which Balsalazide disodium is the first listed.

NCT00408174 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00408174 about?

NCT00408174 is a clinical study titled "Balsalazide Disodium vs. Mesalamine in Mildly to Moderately Active Ulcerative Colitis". 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 6 weeks of therapy.

What is the current status of trial NCT00408174?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 400 participants. The study started on 2006-05. Estimated completion is 2007-11.

What interventions are being tested in trial NCT00408174?

The interventions under investigation include: Balsalazide disodium (DRUG).

Who is sponsoring clinical trial NCT00408174?

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

How this trial's enrollment target compares

Where NCT00408174's enrollment target sits among peer trials

400 922nd of 2000 higher than 1,039 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00408174, the US trial registry maintained by the National Library of Medicine. NCT00408174 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.