Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Recruiting Phase 2 study of Gastroesophageal Reflux Disease (GERD), sponsored by Takeda.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Daily electronic diaries (eDiaries) will be completed which contain Pediatric Gastroesophageal Reflux Disease Symptom Daily Diaries (PGSDD) questionnaires that document presence or absence of hurting or burning in the stomach, chest or throat vomiting, regurgitation and trouble eating. Parents or caregivers of participants aged 2 to 8 years will complete the PGSDD (parent) in the eDiary for their child and participants aged 9 to 11 years will complete PGSDD (child) in the eDiary themselves. The
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2023-02-20 |
| Est. Completion | 2027-10-31 |
| Phase | Phase 2 |
What NCT02616302 shows while recruiting
NCT02616302 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 2,519-participant average among 5 other Gastroesophageal Reflux Disease (GERD) trials with a reported enrollment target (97% lower).
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 names 20 study sites across 17 states, led by 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.
Learn More About Clinical Trials
Similar trials for Gastroesophageal Reflux Disease (GERD)
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.
-
Indiana University Gastrointestinal Motility Diagnosis Registry
RECRUITING
-
Esophageal Cancer Risk Registry
RECRUITING
-
Is the Neosquamous Epithelium "Normal" Following Endoscopic Ablation of Dysplastic Barrett's Esophagus?
COMPLETED
-
Rabeprazole Extended Release 50 mg Versus Ranitidine 150 mg for Maintenance of Healed Erosive Gastroesophageal Reflux Disease (GERD)
COMPLETED · Phase 3
-
Racial Disparity in Barrett's Esophagus
COMPLETED
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00969111 · 70 participants · NA
Postoperative or Salvage Radiotherapy (RT) for Node Negative Prostate Cancer Following Radical Prostatectomy
- NCT01712620 · 70 participants · Phase 2
Spironolactone for Pulmonary Arterial Hypertension
- NCT02143830 · 70 participants · Phase 2
HSCT for Patients With Fanconi Anemia Using Risk-Adjusted Chemotherapy
- NCT02601339 · 70 participants
NIRS Monitoring in Premature Infants
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI