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NCT00321984 · ClinicalTrials.gov registry record · Phase 3

Safety and Efficacy of Dexlansoprazole Modified Release Formulation to Treat Gastroesophageal Reflux Disease

A Phase 3 study, sponsored by Takeda.

Completed
Registry status
Phase 3
Development phase
947
Enrollment target

NCT00321984 is a Phase 3 study that has completed, run by Takeda. The registered enrollment target is 947 participants.

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The verdict

NCT00321984, a Phase 3 study, has completed, sponsored by Takeda.

COMPLETED
Registry status
Phase 3
Development phase
947 participants
Enrollment target

Study Summary

The purpose of this study is to assess the efficacy and safety of Dexlansoprazole modified release (MR) (30 mg once daily \[QD\] or 60 mg QD) compared to placebo in relief of daytime and nighttime heartburn over 4 weeks in subjects with symptomatic, nonerosive gastroesophageal reflux disease (GERD).

Interventions

  • DRUG Placebo
  • DRUG Dexlansoprazole MR

Trial Details

FieldValue
Enrollment Target 947 participants
Start Date 2006-06
Est. Completion 2006-12
Phase Phase 3

Sponsor

Takeda

408 total trials

What the Registry Record Tells You About NCT00321984

The ClinicalTrials.gov registry entry for NCT00321984 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 947 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Takeda, which has 408 total studies on file at ClinicalTrials.gov.

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

NCT00321984 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00321984 about?

NCT00321984 is a clinical study titled "Safety and Efficacy of Dexlansoprazole Modified Release Formulation to Treat Gastroesophageal Reflux Disease". The purpose of this study is to assess the efficacy and safety of Dexlansoprazole modified release (MR) (30 mg once daily \[QD\] or 60 mg QD) compared to placebo in relief of daytime and nighttime heartburn over 4 weeks in subjects with symptomatic, nonerosive gastroesophageal reflux disease (GERD).

What is the current status of trial NCT00321984?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 947 participants. The study started on 2006-06. Estimated completion is 2006-12.

What interventions are being tested in trial NCT00321984?

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

Who is sponsoring clinical trial NCT00321984?

This trial is sponsored by Takeda, which has 408 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.