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NCT01642615 · ClinicalTrials.gov registry record · Phase 2

Safety and Efficacy of Dexlansoprazole Delayed-Release Capsules for Healing of Erosive Esophagitis and Maintenance of Healed Erosive Esophagitis and Relief of Heartburn in Adolescents

A Phase 2 study of Gastroesophageal Reflux Disease and Erosive Esophagitis, sponsored by Takeda.

Completed
Registry status
Phase 2
Development phase
63
Enrollment target
20
Study locations

NCT01642615 is a Phase 2 study of Gastroesophageal Reflux Disease and Erosive Esophagitis that has completed, run by Takeda. The registered enrollment target is 63 participants, below the 345-participant average among 24 other Gastroesophageal Reflux Disease trials with a reported enrollment target (82% lower). The trial reports 20 study locations across 14 states.

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The verdict

NCT01642615, a Phase 2 study of Gastroesophageal Reflux Disease and Erosive Esophagitis, has completed, sponsored by Takeda.

COMPLETED
Registry status
Phase 2
Development phase
63 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is to assess the safety and effectiveness of treatment with once daily oral administration of dexlansoprazole delayed-release capsules in adolescents with erosive esophagitis (EE) and for maintenance of healed EE and relief of heartburn.

Conditions Studied

Gastroesophageal Reflux Disease Erosive Esophagitis

Interventions

  • DRUG Placebo
  • DRUG Dexlansoprazole

Study Locations (20)

California

  • - Anaheim
  • - Los Angeles
  • - San Francsco

Alabama

  • - Huntsville
  • - Mobile

Arizona

  • - Phoenix
  • - Tucson

Colorado

  • - Centennial
  • - Thornton

Illinois

  • - Chicago
  • - Park Ridge

Indiana

  • - Indianapolis

Kentucky

  • - Louisville

Massachusetts

  • - Boston

Trial Details

FieldValue
Enrollment Target 63 participants
Start Date 2012-07
Est. Completion 2014-11
Phase Phase 2

Sponsor

Takeda

408 total trials

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What the Registry Record Tells You About NCT01642615

The ClinicalTrials.gov registry entry for NCT01642615 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 63 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 345-participant average among 24 other Gastroesophageal Reflux Disease trials with a reported enrollment target (82% lower). The listed sponsor is Takeda, which has 408 total studies on file at ClinicalTrials.gov.

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

NCT01642615 reports 20 study locations spanning 14 distinct geographic areas - top geographies include California, Alabama, Arizona.

Frequently Asked Questions

What is clinical trial NCT01642615 about?

NCT01642615 is a clinical study titled "Safety and Efficacy of Dexlansoprazole Delayed-Release Capsules for Healing of Erosive Esophagitis and Maintenance of Healed Erosive Esophagitis and Relief of Heartburn in Adolescents". The purpose of this study is to assess the safety and effectiveness of treatment with once daily oral administration of dexlansoprazole delayed-release capsules in adolescents with erosive esophagitis (EE) and for maintenance of healed EE and relief of heartburn.

What is the current status of trial NCT01642615?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 63 participants. The study started on 2012-07. Estimated completion is 2014-11.

What conditions does trial NCT01642615 study?

This clinical trial studies the following conditions: Gastroesophageal Reflux Disease, Erosive Esophagitis.

What interventions are being tested in trial NCT01642615?

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

Who is sponsoring clinical trial NCT01642615?

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

Where is trial NCT01642615 being conducted?

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

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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.