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

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 353-participant average among 25 other Gastroesophageal Reflux Disease trials with a reported enrollment target (82% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A Treatment Emergent Adverse Event (TEAE) is defined

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
Takeda

408 total trials

What the finished NCT01642615 record still lists

NCT01642615 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 63 participants, a relatively small participant target, below the 353-participant average among 25 other Gastroesophageal Reflux Disease trials with a reported enrollment target (82% lower).

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 names 20 study sites across 14 states, led by 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.

Learn More About Clinical Trials

Similar trials for Gastroesophageal Reflux Disease

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 NCT01642615's enrollment target sits among peer trials

63 16th of 25 higher than 10 of 25 other Gastroesophageal Reflux Disease trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Gastroesophageal Reflux Disease 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 NCT01642615, the US trial registry maintained by the National Library of Medicine. NCT01642615 (small enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.