A research study for subjects with clinically significant heartburn

Updated on 23 November 2020


This study will assess the efficacy and safety of study drug, vonoprazan (20 mg once daily [QD]) compared to lansoprazole (30 mg QD) in the healing and relief of heartburn in subjects with endoscopically proven Erosive Esophagitis (EE).



Study Duration: Following an initial Screening period (of up to 35 days), subjects will be randomized to receive either study medication - vonoprazan 20 mg or lansoprazole 30 mg - for up to 8 weeks. For subjects showing endoscopic healing at week 2 of treatment or week 8 of treatment, they may enter the maintenance phase of the study to continue for 24 weeks. Subjects that do not show endoscopic improvement by week 8 will be discontinued from the study. Subjects will have a safety follow-up visit planned 4 weeks after the last dose of study drug. The total duration of the study is up to 41 weeks.Study Medication/Investigational Product: Eligible study participants will be randomly assigned treatment of vonoprazan 20 mg daily or lansoprazole 30 mg daily in the initial 8 week healing phase. In the maintenance phase, blinded study drug (vonoprazan 10 mg QD, vonoprazan 20 mg QD, or lansoprazole 15 mg QD) will be taken orally for 24 weeks.Study Procedures/Safety Assessments: Physical Exams with the study doctors, vital signs, laboratory test values (hematology, serum chemistry, urinalysis); serum gastrin and pepsinogen I/II levels, gastric biopsy, electrocardiogram (for Maintenance Phase only), twice daily symptom entry in an electronic diary.Stipend: A stipend will be provided to qualified study participants to help defray time and travel costs. Stipends are paid on a periodic basis as specifically outlined in the subject information and consent form.Note: There is no stipend for a pre-study visit, if such a visit is scheduled.

Condition Helicobacter pylori, Heartburn, Gastroesophageal Reflux Disease (GERD), Heartburn (Pediatric)
Clinical Study IdentifierTX237537
Last Modified on23 November 2020


Yes No Not Sure

Inclusion Criteria

Be male or female ≥ 18 years of age
If a male or female of reproductive age/childbearing potential
Be willing to use contraception (birth control) throughout study participation
Not planning pregnancy
Not a currently pregnant or currently lactating female
Have a diagnosis of erosive esophagitis (EE) of LA classification Grades A to D confirmed endoscopically during the screening period

Exclusion Criteria

The subject is determined to be positive for Helicobacter pylori (HP) or has had an HP infection within 45 days of randomization
The subject has endoscopic Barrett's esophagus (>1 cm of columnar-lined esophagus) and/or definite dysplastic changes in the esophagus OR any other condition affecting the esophagus
An active gastric or duodenal ulcer at the start of the screening period
The subject has a history of malignancy (including MALToma) or has been treated for malignancy within 5 years prior to the start of the Screening Period
_The subject may be included in the study if he/she has cured cutaneous basal cell carcinoma or cervical carcinoma in situ._
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