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NCT00627016 · ClinicalTrials.gov registry record · Phase 3

A Study of Dexlansoprazole Modified Release Formulation to Treat Night Heartburn

A Phase 3 study of Gastroesophageal Reflux, sponsored by Takeda.

Completed
Registry status
Phase 3
Development phase
305
Enrollment target
20
Study locations

NCT00627016: Completed Phase 3 study of Gastroesophageal Reflux, sponsored by Takeda.

NCT00627016 is a Phase 3 study of Gastroesophageal Reflux that has completed, run by Takeda. The registered enrollment target is 305 participants, below the 2,877-participant average among 33 other Gastroesophageal Reflux trials with a reported enrollment target (89% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00627016, a Phase 3 study of Gastroesophageal Reflux, has completed, sponsored by Takeda.

COMPLETED
Registry status
Phase 3
Development phase
305 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is to determine whether Dexlansoprazole once daily (QD) is effective in treating patients with night heartburn.

Primary Outcome

Percentage calculated by the number of heartburn-free nights out of the total number of nights during the treatment period with a diary entry indicating presence or absence of nighttime heartburn in subjects who had ≥1 diary entry indicating presence or absence of nighttime heartburn, as indicated by the subject's daily diary. Subjects indicate the presence (Yes/No) of nocturnal heartburn symptoms in a Daily Electronic Diary. Nights missing diary results were excluded from the numerator and deno

Conditions Studied

Gastroesophageal Reflux

Interventions

  • DRUG Placebo
  • DRUG Dexlansoprazole

Study Locations (20)

California

  • - Anaheim
  • - Garden Grove
  • - Lancaster
  • - Oakland
  • - San Diego
  • - Sherwood
  • - Westlake Village

Florida

  • - Jupiter
  • - Miami
  • - New Smyrna Beach
  • - Ocala
  • - St. Petersburg
  • - Zephyrhills

Arizona

  • - Tucson

Illinois

  • - Moline

Iowa

  • - Clive

Kansas

  • - Wichita

Louisiana

  • - Metairie

Maryland

  • - Prince Frederick

Trial Details

FieldValue
Enrollment Target 305 participants
Start Date 2008-03
Est. Completion 2009-03
Phase Phase 3
Takeda

408 total trials

What the finished NCT00627016 record still lists

NCT00627016 is an interventional study that assigns participants to a tested intervention. The registered 305 participants enrollment target is mid-sized for trials with a published cap, below the 2,877-participant average among 33 other Gastroesophageal Reflux trials with a reported enrollment target (89% lower).

The record links to 1 condition, with Gastroesophageal Reflux appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT00627016 names 20 study sites across 9 states, led by California, Florida, Arizona.

Frequently Asked Questions

What is clinical trial NCT00627016 about?

NCT00627016 is a clinical study titled "A Study of Dexlansoprazole Modified Release Formulation to Treat Night Heartburn". The purpose of this study is to determine whether Dexlansoprazole once daily (QD) is effective in treating patients with night heartburn.

What is the current status of trial NCT00627016?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 305 participants. The study started on 2008-03. Estimated completion is 2009-03.

What conditions does trial NCT00627016 study?

This clinical trial studies the following conditions: Gastroesophageal Reflux.

What interventions are being tested in trial NCT00627016?

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

Who is sponsoring clinical trial NCT00627016?

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

Where is trial NCT00627016 being conducted?

This trial has 20 study locations across Arizona, California, Florida, Illinois, Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Gastroesophageal Reflux

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00627016's enrollment target sits among peer trials

305 6th of 33 higher than 28 of 33 other Gastroesophageal Reflux trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Gastroesophageal Reflux 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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Related registry views

Source: ClinicalTrials.gov NCT00627016, the US trial registry maintained by the National Library of Medicine. NCT00627016 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.