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NCT00255164 · ClinicalTrials.gov registry record · Phase 3

Efficacy and Safety of Dexlansoprazole MR on Maintaining Healing in Subjects With Healed Erosive Esophagitis

A Phase 3 study, sponsored by Takeda.

Completed
Registry status
Phase 3
Development phase
451
Enrollment target

NCT00255164: Completed Phase 3 study, sponsored by Takeda.

NCT00255164 is a Phase 3 study that has completed, run by Takeda. The registered enrollment target is 451 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (42% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00255164, a Phase 3 study, has completed, sponsored by Takeda.

COMPLETED
Registry status
Phase 3
Development phase
451 participants
Enrollment target

Study Summary

The purpose of this study is to assess the ability of once-daily (QD) treatment with Dexlansoprazole modified-release (MR) 60 mg and 90 mg and placebo in maintaining healing of erosive esophagitis (EE).

Primary Outcome

Crude rates analyzed maintenance of healed EE from baseline of this study and considered prematurely discontinued subjects as relapsed.

Interventions

  • DRUG Placebo
  • DRUG Dexlansoprazole MR

Trial Details

FieldValue
Enrollment Target 451 participants
Start Date 2006-01
Est. Completion 2006-11
Phase Phase 3
Takeda

408 total trials

What the finished NCT00255164 record still lists

NCT00255164 is an interventional study that assigns participants to a tested intervention. The registered 451 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 (42% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT00255164 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00255164 about?

NCT00255164 is a clinical study titled "Efficacy and Safety of Dexlansoprazole MR on Maintaining Healing in Subjects With Healed Erosive Esophagitis". The purpose of this study is to assess the ability of once-daily (QD) treatment with Dexlansoprazole modified-release (MR) 60 mg and 90 mg and placebo in maintaining healing of erosive esophagitis (EE).

What is the current status of trial NCT00255164?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 451 participants. The study started on 2006-01. Estimated completion is 2006-11.

What interventions are being tested in trial NCT00255164?

The interventions under investigation include: Placebo (DRUG), Dexlansoprazole MR (DRUG).

Who is sponsoring clinical trial NCT00255164?

This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00255164's enrollment target sits among peer trials

451 836th of 2000 higher than 1,164 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 NCT00255164, the US trial registry maintained by the National Library of Medicine. NCT00255164 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.