Efficacy and Safety of Dexlansoprazole Modified Release Formulation to Treat Heartburn (NCT00251745) | Clinical Trial Compass
CompletedPhase 3
Efficacy and Safety of Dexlansoprazole Modified Release Formulation to Treat Heartburn
United States908 participantsStarted 2005-12
Plain-language summary
The purpose of this study is to assess the efficacy and safety of daily treatment with Dexlansoprazole modified release (MR) (60 mg or 90 mg once daily \[QD\]) compared to placebo QD in relief of daytime and nighttime heartburn over 4 weeks in subjects with gastroesophageal reflux disease (GERD).
Who can participate
Age range
18 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:
* Subjects with Non-Erosive Gastroesophageal Reflux Disease identifying their main symptom as heartburn.
* History of episodes of heartburn for 6 months or longer prior to screening.
* History of episodes of heartburn for 4 or more days during the 7 days prior to Day -1 as recorded in the electronic diary.
Exclusion Criteria:
* Use of prescription or non-prescription proton pump inhibitors (PPIs), histamine (H2) receptor antagonists, sucralfate, misoprostol or prokinetics throughout the study·
* Use of antacids (except for study supplied Gelusil®).
* Use of drugs with significant anticholinergic effects.
* Need for continuous anticoagulant (blood thinner) therapy.
* Endoscopic Barrett's esophagus and/or definite dysplastic changes in the esophagus.
* History of dilatation of esophageal strictures, other than a Schatzki's ring (a ring of mucosal tissue near the lower esophageal sphincter).
* Current or historical evidence of Zollinger-Ellison syndrome or other hypersecretory condition.
* History of gastric, duodenal or esophageal surgery except simple oversew of an ulcer.
* Acute upper gastrointestinal (UGI) hemorrhage within 4 weeks of the screening endoscopy.
* Erosive Esophagitis seen on endoscopy during study screening.
* Co-existing diseases affecting the esophagus.
* Abnormal laboratory values that suggest significant clinical disease.
* Known acquired immunodeficiency syndrome (AIDS)
* Females pregnant or lactating.
* History of Alcohol abuse.
* H…
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 Days With Neither Daytime Nor Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Median
Timeframe: 4 weeks
2
Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Mean