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NCT02615184 · ClinicalTrials.gov registry record · Phase 2
A Study to Check the Safety of Dexlansoprazole and Learn If it Can Heal Erosive Esophagitis (EE) and Keep it Healed in Children 2 to 11 Years Old
A Phase 2 study of Erosive Esophagitis, sponsored by Takeda.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 76
- Enrollment target
- 20
- Study locations
NCT02615184: Recruiting Phase 2 study of Erosive Esophagitis, sponsored by Takeda.
NCT02615184 is a Phase 2 study of Erosive Esophagitis that is actively recruiting participants, run by Takeda. The registered enrollment target is 76 participants, below the 198-participant average among 6 other Erosive Esophagitis trials with a reported enrollment target (62% lower). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02615184, a Phase 2 study of Erosive Esophagitis, is actively recruiting participants, sponsored by Takeda.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 76 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. Sometimes GERD damages the lining of the esophagus, creating breaks. This is called erosive esophagitis (EE). Dexlansoprazole is a type of medicine that helps lower the amount of acid made in the stomach. It has been shown to heal EE and maintain (keep) healing of EE in adults and teenagers. This study is being done to find out if dexlansoprazole can also heal EE and maintain the healing of EE in children.
Primary Outcome
Healing of EE will be assessed by endoscopy.
Conditions Studied
Interventions
- DRUG Dexlansoprazole
Study Locations (20)
Other
- Hospital Universitario San Ignacio - Bogotá
- Fundacion Valle del Lili - Cali
- Centro Medico Imbanaco de Cali S.A - Cali
- El Cielo Medical Center - Puebla City
Tennessee
- GI for Kids - Knoxville
- Vanderbilt University Medical Center - Nashville
Alabama
- University of South Alabama - Mobile
California
- University of California San Francisco - San Francisco
Florida
- D&H National Research Centers - Miami
Georgia
- Children's Center for Digestive Health Care, LLC - Atlanta
Mississippi
- Gastrointestinal Associates, PA - Flowood
Ohio
- University Hospitals Cleveland Medical Center - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 76 participants |
| Start Date | 2023-05-23 |
| Est. Completion | 2027-10-31 |
| Phase | Phase 2 |
What NCT02615184 shows while recruiting
NCT02615184 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 76 participants, a relatively small participant target, below the 198-participant average among 6 other Erosive Esophagitis trials with a reported enrollment target (62% lower).
The record links to 1 condition, with Erosive Esophagitis appearing as the primary indexed condition, and to 1 intervention - of which Dexlansoprazole is the first listed.
NCT02615184 names 20 study sites across 16 states, led by Other, Tennessee, Alabama.
Frequently Asked Questions
What is clinical trial NCT02615184 about?
NCT02615184 is a clinical study titled "A Study to Check the Safety of Dexlansoprazole and Learn If it Can Heal Erosive Esophagitis (EE) and Keep it Healed 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 NCT02615184?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 76 participants. The study started on 2023-05-23. Estimated completion is 2027-10-31.
What conditions does trial NCT02615184 study?
This clinical trial studies the following conditions: Erosive Esophagitis.
What interventions are being tested in trial NCT02615184?
The interventions under investigation include: Dexlansoprazole (DRUG).
Who is sponsoring clinical trial NCT02615184?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02615184 being conducted?
This trial has 20 study locations across Alabama, California, Florida, Georgia, Mississippi. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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