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NCT01642602 · ClinicalTrials.gov registry record · Phase 2

Safety and Efficacy of Dexlansoprazole Delayed-Release Capsules in Treating Symptomatic Non-Erosive Gastroesophageal Reflux Disease in Adolescents

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

Completed
Registry status
Phase 2
Development phase
104
Enrollment target
20
Study locations

NCT01642602: Completed Phase 2 study of Gastroesophageal Reflux Disease, sponsored by Takeda.

NCT01642602 is a Phase 2 study of Gastroesophageal Reflux Disease that has completed, run by Takeda. The registered enrollment target is 104 participants, below the 352-participant average among 25 other Gastroesophageal Reflux Disease trials with a reported enrollment target (70% 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

NCT01642602, a Phase 2 study of Gastroesophageal Reflux Disease, has completed, sponsored by Takeda.

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

Study Summary

The purpose of this study was to assess the safety and effectiveness of once daily oral administration of dexlansoprazole delayed-release capsules in adolescent participants with symptomatic non-erosive gastroesophageal reflux disease (GERD).

Primary Outcome

A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that started or worsened on or after Study Day 1 (defined as first dose day), and no more than 30 days after the last dose of study drug.

Conditions Studied

Gastroesophageal Reflux Disease

Interventions

  • DRUG Dexlansoprazole

Study Locations (20)

California

  • - Anaheim
  • - Los Angeles
  • - San Francsco

Alabama

  • - Huntsville
  • - Mobile

Arizona

  • - Phoenix
  • - Tucson

Colorado

  • - Centennial
  • - Thornton

Illinois

  • - Chicago
  • - Park Ridge

Florida

  • - Miami

Georgia

  • - Atlanta

Indiana

  • - Indianapolis

Trial Details

FieldValue
Enrollment Target 104 participants
Start Date 2012-07
Est. Completion 2014-01
Phase Phase 2
Takeda

408 total trials

What the finished NCT01642602 record still lists

NCT01642602 is an interventional study that assigns participants to a tested intervention. The registered 104 participants enrollment target is mid-sized for trials with a published cap, below the 352-participant average among 25 other Gastroesophageal Reflux Disease trials with a reported enrollment target (70% lower).

The record links to 1 condition, with Gastroesophageal Reflux Disease appearing as the primary indexed condition, and to 1 intervention - of which Dexlansoprazole is the first listed.

NCT01642602 names 20 study sites across 14 states, led by California, Alabama, Arizona.

Frequently Asked Questions

What is clinical trial NCT01642602 about?

NCT01642602 is a clinical study titled "Safety and Efficacy of Dexlansoprazole Delayed-Release Capsules in Treating Symptomatic Non-Erosive Gastroesophageal Reflux Disease in Adolescents". The purpose of this study was to assess the safety and effectiveness of once daily oral administration of dexlansoprazole delayed-release capsules in adolescent participants with symptomatic non-erosive gastroesophageal reflux disease (GERD).

What is the current status of trial NCT01642602?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 104 participants. The study started on 2012-07. Estimated completion is 2014-01.

What conditions does trial NCT01642602 study?

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

What interventions are being tested in trial NCT01642602?

The interventions under investigation include: Dexlansoprazole (DRUG).

Who is sponsoring clinical trial NCT01642602?

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

Where is trial NCT01642602 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Colorado, Florida. 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 NCT01642602's enrollment target sits among peer trials

104 13th of 25 higher than 13 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 NCT01642602, the US trial registry maintained by the National Library of Medicine. NCT01642602 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.