Safety and Efficacy of Dexlansoprazole Delayed-Release Capsules for Healing of Erosive Esophagiti… (NCT01642615) | Clinical Trial Compass
CompletedPhase 2
Safety and Efficacy of Dexlansoprazole Delayed-Release Capsules for Healing of Erosive Esophagitis and Maintenance of Healed Erosive Esophagitis and Relief of Heartburn in Adolescents
United States, Belgium, Brazil63 participantsStarted 2012-07
Plain-language summary
The purpose of this study is to assess the safety and effectiveness of treatment with once daily oral administration of dexlansoprazole delayed-release capsules in adolescents with erosive esophagitis (EE) and for maintenance of healed EE and relief of heartburn.
Who can participate
Age range
12 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. In the opinion of the investigator, the participant and parent(s) or legal guardian are capable of understanding and complying with protocol requirements.
. Prior to any study-specific procedures being performed, the informed consent and the assent form, according to local country requirements, must be signed and dated by parent(s) or legal guardian and by the participant respectively.
. The participant has a medical history of symptoms of Gastroesophageal Reflux Disease (GERD) for at least 3 months prior to Screening (signed informed consent form and assent, if applicable) as assessed by the investigator.
. The participant has met the electronic diary qualification criteria as assessed by the electronic daily diary defined as follows: heartburn (burning or hurting in your throat, chest, or stomach) on at least 3 of 7 days.(Note: if an endoscopy done within 1 week of signing informed consent and assent is used to confirm diagnosis of EE, the subject does not need to meet this criterion).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of Participants Who Experience Each Treatment Emergent Adverse Event Experienced by ≥5% of Participants During the 8-week Healing Treatment Period
Timeframe: 8 weeks
2
Percent of Participants Who Experience Each Treatment Emergent Adverse Event Experienced by ≥5% of Participants During the 16-week Maintenance Treatment Period
. The participant has endoscopic evidence of EE (LA Grade A-D) based on the screening endoscopy.
. The participant is male or female and aged 12 to 17 years, inclusive.
. A male participant who is nonsterilized and sexually active with a female partner of childbearing potential agrees to use adequate contraception from signing of informed consent and assent throughout the duration of the study and for 30 days after last dose of study medication.
. A female participant of childbearing potential who is or may become sexually active agrees to routinely use adequate contraception from the time of signing the informed consent and assent until 30 days after the last dose of study medication.
Exclusion criteria
. Participant has evidence of cardiovascular, pulmonary, central nervous system, hepatic, hematopoietic, renal, metabolic, endocrine or gastrointestinal disease, or serious allergy, asthma, or allergic skin rash that suggests clinically significant, uncontrolled underlying disease or condition (other than the disease being studied), which may impact the ability of the participant to participate or potentially confound the study results.
. The participant has a co-existing disease affecting the esophagus (eg, esophageal varices, scleroderma, viral or fungal infection, or esophageal stricture), history of radiation therapy or cryotherapy to the esophagus, caustic or physiochemical trauma such as sclerotherapy to the esophagus.
. The participant has known history of Barrett's with dysplastic changes in the esophagus.
. The participant has a known history of eosinophilic esophagitis (EoE) or endoscopic findings suggestive of EoE.
. The participant has a history of celiac disease or participant tests positive for tissue transglutaminase (tTG) antibody.
. The participant has active gastric or duodenal ulcers within 4 weeks prior to Day -1.
. Participant has any finding in his/her medical history, physical examination, or safety clinical laboratory tests giving reasonable suspicion of underlying disease that might interfere with the conduct of the trial.
. Participant has taken any proton pump inhibitor (PPI) within 1 week (7 days) prior to the Screening Visit.