Efficacy of Dexlansoprazole MR on Heartburn Control in Participants Previously Receiving Twice Da… (NCT00847808) | Clinical Trial Compass
CompletedPhase 3
Efficacy of Dexlansoprazole MR on Heartburn Control in Participants Previously Receiving Twice Daily Proton Pump Inhibitor Therapy
United States178 participantsStarted 2009-02
Plain-language summary
The purpose of this study is to determine if patients with well-controlled heartburn symptoms on twice-daily proton pump inhibitor therapy remain well-controlled after stepping down to once-daily (QD) dexlansoprazole modified release (MR) 30 mg.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Prior to any study-specific procedures being performed, the participant voluntarily signs an Investigational Review Board-approved informed consent form (ICF) and any privacy statement/authorization form required (eg, The Health Insurance Portability and Accountability Act (HIPAA) authorization)
✓. Has a history of gastroesophageal reflux disease symptom, including heartburn, prior to therapy, who are currently being treated with twice daily proton pump inhibitors, excluding Dexilant (dexlansoprazole).
✓. Taking a stable dose of any twice daily proton pump inhibitors for less than or equal to 1 year and greater than 8 weeks prior to Screening.
✓. Participant is well-controlled on their current twice daily proton pump inhibitors.
✓. Females cannot be nursing and must have a negative urine pregnancy test at Day -1 or be of non-childbearing potential. If females are of child bearing potential, must have a negative serum human chorionic gonadotropin (hCG) pregnancy test during Screening and on an acceptable form of contraception, or have had bilateral tubal ligation if performed a minimum of 90 days prior to Day 1.
Exclusion criteria
✕. Has a history of co-existing diseases affecting the esophagus, history of radiation therapy or cryotherapy to the esophagus, caustic or physiochemical trauma such as sclerotherapy to the esophagus.
✕. Has active gastric or duodenal ulcers during the 30 days prior to Screening.
✕. Has acute upper gastrointestinal hemorrhage during the 30 days prior to Screening.
✕
What they're measuring
1
Proportion of Participants Who Remain Well Controlled After Switching From Their Current Twice-daily Proton Pump Inhibitor Therapy to Dexlansoprazole MR.