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Dexlansoprazole for Acid Reflux in Children
Study Summary
This trial will test the side effects and effectiveness of Dexlansoprazole in children with GERD.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2016 Phase 4 trial • 296 Patients • NCT02351960Trial Design
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- I might need surgery that requires a hospital stay during the study.I need a procedure to widen my esophagus to allow an endoscope to pass.I do not have severe allergies, asthma, or serious health issues affecting my heart, lungs, liver, kidneys, blood, brain, or metabolism.I have been diagnosed with celiac disease.I have a history of inflammatory or irritable bowel disease.I have not had active stomach or upper small intestine ulcers in the last 4 weeks.I am a woman and have had my first menstrual period.I have or had a condition that causes excessive stomach acid.I have had symptoms of acid reflux for at least 3 months.I tried stopping my acid reflux medication before, but my symptoms came back.I have not had major stomach or esophagus surgery, except for ulcer repair.I haven't donated blood, had a transfusion, or undergone plasmapheresis in the last 3 months.I am between 2 and 11 years old.I tried stopping my acid reflux medication before, but my symptoms came back.I had severe bleeding in my stomach or upper intestines within the last month.You have experienced stomach, chest, or throat pain or burning for at least 3 days out of a 7-day period, and this has been confirmed by the study doctor.I have Barrett's esophagus with changes in my esophagus cells.I am allergic to dexlansoprazole or similar heartburn medications.I don't need to take any medications that aren't allowed in the study.I (or my guardian) understand and can follow the study's requirements.I have not had any diseases, treatments, or injuries to my esophagus.I have been diagnosed with or show signs of eosinophilic esophagitis.
- Group 1: Weight >30 kg: Dexlansoprazole 30 mg
- Group 2: Weight ≤30 kg: Dexlansoprazole 30 mg
- Group 3: Weight ≤30 kg: Dexlansoprazole 15 mg
- Group 4: Weight >30 kg: Dexlansoprazole 60 mg
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is the enrollment pool of this research project restricted to adults aged 18 and above?
"Patients aged between 2 and 11 years old are eligible to join this medical trial."
What do physicians typically prescribe Dexlansoprazole for?
"Dexlansoprazole is an effective remedy for healing erosive esophagitis, heartburn, and other related ailments."
How many individuals are participating in the experiment?
"As of the date of this writing, no recruitment is being conducted for this clinical trial. Initially released on November 28th 2022 and recently modified September 16th 2022, it does not currently have any open slots for participation. Other related studies are underway with 80 trials recruiting patients suffering from esophagitis, peptic ulcer disease four separate ones involving Dexlansoprazole specifically looking to admit participants."
What other experimental trials have been conducted regarding Dexlansoprazole?
"Presently, there are four clinical trials actively examining the efficacy of Dexlansoprazole with zero studies in Phase 3. Although most experiments related to this drug occur in Bucheon, Gyeonggi-do, a total of 48 sites across the world have been designated for patient testing."
Are there any available slots in this research endeavor for participants?
"Clinicaltrials.gov reports that recruitment for this clinical trial has been closed since September 16th, 2022; the study was initially announced on November 28th of the same year. That said, there are 84 other trials actively searching for participants at present."
What qualifications do individuals need to be accepted for participation in this trial?
"This clinical trial is in search of 70 minors aged 2 to 11 that are afflicted with esophagitis and peptic. To be eligible, the participant (or parent/guardian depending on age) must agree to sign consent forms and have a medical history indicating 3 months or more of GERD-related symptoms which persisted after withdrawal from acid suppressant therapy. Furthermore, diary entries showing pain or burning in stomach/chest/throat on at least three out of seven days during screening period will also qualify potential participants for enrollment. Lastly, an endoscopy within 1 week prior to signing the consent form may replace the need for a"
What potential risks have been associated with Dexlansoprazole consumption?
"The safety rating for Dexlansoprazole is 2 since it has only been studied in Phase 2 trials and there are no efficacy data available."
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