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NCT02616302 · ClinicalTrials.gov registry record · Phase 2

A Study to Check the Safety of Dexlansoprazole and Learn if it Can Treat Symptomatic Nonerosive Gastroesophageal Reflux Disease in Children 2 to 11 Years Old

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

Recruiting
Registry status
Phase 2
Development phase
70
Enrollment target
20
Study locations

NCT02616302 is a Phase 2 study of Gastroesophageal Reflux Disease (GERD) that is actively recruiting participants, run by Takeda. The registered enrollment target is 70 participants, below the 2,519-participant average among 5 other Gastroesophageal Reflux Disease (GERD) trials with a reported enrollment target (97% lower). The trial reports 20 study locations across 17 states.

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The verdict

NCT02616302, a Phase 2 study of Gastroesophageal Reflux Disease (GERD), is actively recruiting participants, sponsored by Takeda.

RECRUITING
Registry status
Phase 2
Development phase
70 participants
Enrollment target
20
Study locations

Study Summary

Gastroesophageal reflux disease (GERD) is caused by food or acid coming up from the stomach into the esophagus, repeatedly. The esophagus is the tube that carries food and liquids from the mouth to the stomach. The body uses stomach acid to break down food, but when acid rises up into the esophagus it can hurt or damage it. People with GERD often feel food coming back up into the throat and mouth and have a burning feeling in their stomach, chest, or throat, called heartburn. Other symptoms of GERD include pain in the stomach or throat, difficulty eating, and throwing up. Symptomatic nonerosive GERD is a condition where people have the symptoms of GERD but the esophagus has not been damaged. People of all ages can have GERD. The causes of GERD in children are similar to those in adults and teenagers. Dexlansoprazole is a medicine that has been shown to help relieve the symptoms of GERD in adults and teenagers. This study aims to find out if dexlansoprazole doses given to children with symptomatic nonerosive GERD, based on their body weight, helps them feel better.

Conditions Studied

Gastroesophageal Reflux Disease (GERD)

Interventions

  • DRUG Dexlansoprazole

Study Locations (20)

Oklahoma

  • Dartmouth-Hitchcock Manchester - Oklahoma City
  • University of California San Francisco - Oklahoma City

Tennessee

  • c/o Chelsea Campbell, RN - Knoxville
  • Vanderbilt University Medical Center, - Nashville

Texas

  • Oklahoma Pediatric Digestive Institute - El Paso
  • University Hospitals Cleveland Medical Center - Laredo

Alabama

  • Childrens Center for Digestive Health Care, LLC - Mobile

California

  • University of Utah/ Primary Childrens Hospital - San Francisco

Colorado

  • Gastrointestinal Associates, PA - Centennial

Florida

  • Envision Clinical Research, LLC - Miami

Georgia

  • GI For Kids - Atlanta

Trial Details

FieldValue
Enrollment Target 70 participants
Start Date 2023-02-20
Est. Completion 2027-10-31
Phase Phase 2

Sponsor

Takeda

408 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02616302

The ClinicalTrials.gov registry entry for NCT02616302 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,519-participant average among 5 other Gastroesophageal Reflux Disease (GERD) trials with a reported enrollment target (97% lower). The listed sponsor is Takeda, which has 408 total studies on file at ClinicalTrials.gov.

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

NCT02616302 reports 20 study locations spanning 17 distinct geographic areas - top geographies include Oklahoma, Tennessee, Texas.

Frequently Asked Questions

What is clinical trial NCT02616302 about?

NCT02616302 is a clinical study titled "A Study to Check the Safety of Dexlansoprazole and Learn if it Can Treat Symptomatic Nonerosive Gastroesophageal Reflux Disease in Children 2 to 11 Years Old". Gastroesophageal reflux disease (GERD) is caused by food or acid coming up from the stomach into the esophagus, repeatedly. The esophagus is the tube that carries food and liquids from the mouth to the stomach. The body uses stomach acid to break down food, but when acid rises up into the esophagus...

What is the current status of trial NCT02616302?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 70 participants. The study started on 2023-02-20. Estimated completion is 2027-10-31.

What conditions does trial NCT02616302 study?

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

What interventions are being tested in trial NCT02616302?

The interventions under investigation include: Dexlansoprazole (DRUG).

Who is sponsoring clinical trial NCT02616302?

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

Where is trial NCT02616302 being conducted?

This trial has 20 study locations across Alabama, California, Colorado, Florida, Georgia. 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.