Vonoprazan Study in Patients With Erosive Esophagitis to Evaluate Long-term Safety
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|ClinicalTrials.gov Identifier: NCT02679508|
Recruitment Status : Active, not recruiting
First Posted : February 10, 2016
Last Update Posted : December 23, 2020
|Condition or disease||Intervention/treatment||Phase|
|Erosive Esophagitis||Drug: Vonoprazan Drug: Lansoprazole||Phase 4|
This is a multicenter, open-label, randomized, parallel-group study to exploratorily evaluate the effect on gastric mucosal tissue and the safety of long-term administration of vonoprazan in maintenance treatment after healed EE, and the curative effect of vonoprazan versus lansoprazole in participants with EE.
Participants endoscopically diagnosed with EE of Los Angeles (LA) Classification Grades A to D at the start of treatment (Week 0 of the healing phase) will be randomly assigned to receive either vonoprazan 20 mg or lansoprazole 30 mg to be taken once daily for up to 8 weeks. Subjects with healed EE as confirmed endoscopically at Week 4 or 8 in the healing phase will enter the maintenance phase.
In the maintenance phase, the vonoprazan group and the lansoprazole group will be administered a starting dose of 10 mg and 15 mg, respectively, once daily up to 260 weeks.
If the principal investigator or investigator judged the effect of vonoprazan 10 mg or lansoprazole 15 mg to be insufficient as the maintenance treatment of EE, vonoprazan and lansoprazole may be increased to 20 mg and 30 mg, respectively.
The research period will consist of two subperiods: healing phase in which participants with EE will receive treatment (for 4 or 8 weeks) and maintenance phase in which participants will receive maintenance treatment (for 260 weeks), and thus, a total of up to 268 weeks. The number of visits will be a maximum of 18 visits. Planned number of research subjects, as the number of research subjects for entry to the maintenance phase, will be 130 participants in the vonoprazan group and 65 participants in the lansoprazole group.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||202 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Vonoprazan Study In Patients With Erosive Esophagitis to Evaluate Long-term Safety: A Study to Evaluate the Safety of Long-term Administration of Vonoprazan in Maintenance Treatment in Patients With Erosive Esophagitis (EE)|
|Actual Study Start Date :||March 29, 2016|
|Estimated Primary Completion Date :||February 28, 2022|
|Estimated Study Completion Date :||February 28, 2022|
Experimental: Vonoprazan group
Vonoprazan 20 mg administered orally once daily in the healing phase + vonoprazan 10 mg (as the initial dose and adjusted to vonoprazan 10 mg or 20 mg) administered orally once daily in the maintenance phase
Vonoprazan fumarate 10 mg or 20 mg capsules
Active Comparator: Lansoprazole group
Lansoprazole 30 mg administered orally once daily in the healing phase + lansoprazole 15 mg (as the initial dose and adjusted to lansoprazole 15 mg or 30 mg) administered orally once daily in the maintenance phase
Lansoprazole 15 mg or 30 mg capsules
- Percentage of participants with clinically significant Gastric mucosa histopathology findings [ Time Frame: Up to Week 268 ]For each gastric mucosa histopathological endpoint (presence or absence of malignant alteration of epithelial cells, presence or absence of prominence/hyperplasia of wall cells, presence or absence of hyperplasia of crypt epithelial cells, presence or absence of proliferation of endocrine cells, and presence or absence of hyperplasia of G cells), the proportion of research participants who have the events for assessment in maintenance phase shall be calculated for each treatment group.
- Endoscopic erosive esophagitis (EE) recurrence rate [ Time Frame: Up to Week 268 ]
- EE healing rate at the end of the healing phase [ Time Frame: Up to Week 8 ]
- Number of Participants Reporting One or More Treatment-emergent Adverse Events [ Time Frame: Up to Week 268 ]An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.
- Percentage of participants with clinically significant endoscopic findings [ Time Frame: Up to Week 268 ]For each endoscopic endpoint (presence or absence of fundic gland polyp, presence or absence of hyperplastic polyp, presence or absence of cobblestone mucosa, presence or absence of multiple white flat elevation, and presence or absence of black spots), the proportion of research participants who have the clinically significant events at each time point for assessment shall be calculated for each treatment group.
- Percentage of participants with clinically significant histological evaluation of gastritis according to the Sydney classification [ Time Frame: Up to Week 268 ]For each histological endpoint of gastritis according to the Sydney classification [inflammation (mononuclear infiltration), activity (neutrophilic infiltration), atrophy, intestinal metaplasia, and H. pylori], the proportion of research participants who have the clinically significant events at each time point for assessment shall be calculated for each treatment group.
- Percentage of participants who have gastric polyp in maintenance phase [ Time Frame: Up to Week 268 ]For gastric polyp, the proportion of research participants who have gastric polyp in maintenance phase of this study shall be calculated for each treatment group.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02679508
|Study Director:||Medical Director||Takeda Pharmaceuticals Limited|