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Efficacy and Safety of Vonopr...

Efficacy and Safety of Vonoprazan Compared to Lansoprazole in the Maintenance Treatment of Erosive Esophagitis

Last Updated: 2020-02-21

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

703 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-01

Study Completion Date

2018-12-31

Brief Summary

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This is a comparative study of vonoprazan (TAK-438) (10 mg or 20 mg) in participants in whom endoscopic healing of erosive esophagitis has been confirmed with vonoprazan or adequate treatment with a proton pump inhibitor (PPI), to demonstrate the non-inferiority of vonoprazan to lansoprazole in their maintenance treatment (6 months or 24 weeks) as well as to determine the clinically recommended dose for vonoprazan for maintenance therapy in erosive esophagitis.

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Detailed Description

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The drug being tested in this study is called vonoprazan. Vonoprazan is being tested as a maintenance treatment for people with healed erosive esophagitis (EE). This study will look at participants in whom endoscopic healing of erosive esophagitis has been confirmed with vonoprazan or adequate treatment with a proton pump inhibitor (PPI), to demonstrate the non-inferiority of vonoprazan to Lansoprazole in their maintenance treatment (6 months or 24 weeks) as well as to determine the clinically recommended dose for vonoprazan for maintenance therapy in erosive esophagitis.

The study will enroll approximately 693 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the three treatment groups-which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):

* TAK-438 10 mg
* TAK-438 20 mg
* Lansoprazole 15 mg

Participants with ongoing erosive esophagitis (EE) will receive lansoprazole 30 mg once daily for 4 or 8 weeks (the Healing phase) until healing of EE is confirmed by endoscopy performed at either Week -4 and/or Day 1 before eligible for randomization to maintenance phase. In Maintenance phase, participants with confirming EE healing will be asked to take 2 tablets and a capsule at the same time each morning after breakfast throughout the study. All participants will be asked to record daytime and nighttime (during sleep) subjective symptoms in a diary on a daily basis.

This multi-centre trial will be conducted worldwide. The overall time to participate in this study is 8 months. Participants will make multiple visits to the clinic, and will be contacted by telephone 7-14 days after last dose of study drug for a follow-up assessment.

Conditions

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Erosive Esophagitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Vonoprazan 10 mg

Lansoprazole 30 mg, capsules or tablets, orally, once, daily, for up to 4 or 8 weeks or until confirmed healing of erosive esophagitis (EE) in healing phase for participants with ongoing EE.

Vonoprazan 10 mg, tablets, orally, once, daily, and Vonoprazan 20 mg, placebo-matching tablets, orally, once, daily, and Lansoprazole 15 mg placebo-matching, capsules, orally, once, daily, for up to 24 weeks in maintenance phase for participants with confirmed EE healing.

Group Type EXPERIMENTAL

Vonoprazan

Intervention Type DRUG

Vonoprazan tablets

Lansoprazole

Intervention Type DRUG

Lansoprazole capsules or tablets

Vonoprazan Placebo

Intervention Type DRUG

Vonoprazan placebo-matching tablets

Lansoprazole Placebo

Intervention Type DRUG

Lansoprazole placebo-matching capsules

Vonoprazan 20 mg

Lansoprazole 30 mg, capsules or tablets, orally, once, daily, for up to 4 or 8 weeks or until confirmed healing of erosive esophagitis (EE) in healing phase for participants with ongoing EE.

Vonoprazan 20 mg, tablets, orally, once, daily, and Vonoprazan 10 mg, placebo-matching tablets, orally, once, daily, and Lansoprazole 15 mg, placebo-matching capsules, orally, once, daily, for up to 24 weeks in maintenance phase for participants with confirmed EE healing

Group Type EXPERIMENTAL

Vonoprazan

Intervention Type DRUG

Vonoprazan tablets

Lansoprazole

Intervention Type DRUG

Lansoprazole capsules or tablets

Vonoprazan Placebo

Intervention Type DRUG

Vonoprazan placebo-matching tablets

Lansoprazole Placebo

Intervention Type DRUG

Lansoprazole placebo-matching capsules

Lansoprazole 15 mg

Lansoprazole 30 mg, capsules or tablets, orally, once, daily, for up to 4 or 8 weeks or until confirmed healing of erosive esophagitis (EE) in healing phase for participants with ongoing EE.

Lansoprazole 15 mg, capsules, orally, once, daily, and Vonoprazan 10 mg, placebo-matching tablets, orally, once, daily, and Vonoprazan 20 mg, placebo-matching tablets, orally, once, daily, for up to 24 weeks in maintenance phase for participants with confirmed EE healing.

Group Type ACTIVE_COMPARATOR

Lansoprazole

Intervention Type DRUG

Lansoprazole capsules or tablets

Vonoprazan Placebo

Intervention Type DRUG

Vonoprazan placebo-matching tablets

Interventions

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Vonoprazan

Vonoprazan tablets

Intervention Type DRUG

Lansoprazole

Lansoprazole capsules or tablets

Intervention Type DRUG

Vonoprazan Placebo

Vonoprazan placebo-matching tablets

Intervention Type DRUG

Lansoprazole Placebo

Lansoprazole placebo-matching capsules

Intervention Type DRUG

Other Intervention Names

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TAK-438 Prevacid

Eligibility Criteria

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Inclusion Criteria

1. In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
2. The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
3. Has been confirmed on endoscopy to have had erosive esophagitis \[Los Angeles (LA) classification grades A to D\] within 84 days of Day 1.
4. If the participant is not rolled over from TAK-438\_303 study, he/she has undergone an open-label Proton pump inhibitor (PPI) treatment (Lansoprazole 30 mg, once daily) of 4 or 8 weeks within the TAK-438\_305 protocol.
5. Has been confirmed on endoscopy to have healing of erosive esophagitis. This endoscopy, if not part of the TAK-438\_303 study, must have been within the last 14 days prior to randomization, otherwise the endoscopy must be repeated to confirm healing before randomization in the TAK-438\_305 study.
6. Is aged 18 years old or older (or the local age of consent if that is older), male or female, at the time of signing an informed consent, and is being treated on an outpatient basis for erosive esophagitis, including those temporarily admitted for examination.
7. A female participant of childbearing potential who is sexually active with a nonsterilized male partner agrees to use routinely adequate contraception from signing of informed consent throughout the duration of the study and for 4 weeks after last dose of study medication.

Exclusion Criteria

1. Has received any investigational compound (other than study TAK-438\_303) within 84 days prior to screening phase.
2. Has received TAK-438 in a previous clinical study (other than study TAK-438\_303) or as a therapeutic agent.
3. Is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in conduct of this study (eg, spouse, parent, child, sibling) or may consent under duress.
4. Has, in the judgment of the investigator, clinically significant abnormal hematological parameters of hemoglobin, hematocrit, or erythrocytes at Screening.
5. Has a history or clinical manifestations of significant central nervous system (CNS), cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urological, endocrine or hematological disease.
6. Has a history of hypersensitivity or allergies to TAK-438 or to proton pump inhibitors (PPIs) including any associated excipients.
7. Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 1 year prior to the start the screening phase.
8. Is required to take excluded medications.
9. If female, the participant is pregnant or lactating or intending to become pregnant before, during, or within 1 month after participating in this study; or intending to donate ova during such time period.
10. Has participated in another clinical study (other than study TAK-438\_303) within the past 30 days from Visit 1.
11. Has co-morbidities that could affect the esophagus (eosinophilic esophagitis, esophageal varices, scleroderma, viral or fungal infection, esophageal strictures), a history of radiotherapy or cryotherapy for the esophagus; those with corrosive or physiochemical injury (with the possible inclusion in the study of those with Schatzki's ring or Barrett's esophagus).
12. Has a history of surgical procedures that may affect the esophagus (eg, fundoplication and mechanical dilatation for esophageal strictures excluding Schatzki's ring) or a history of gastric or duodenal surgery excluding endoscopic removal of benign polyps.
13. Developed acute upper gastrointestinal bleeding, gastric ulcer (a mucosal defect with white coating) or duodenal ulcer (a mucosal defect with white coating), within 30 days before the start of the Screening Phase (Visit 1) (with the possible inclusion of those with gastric or duodenal erosion). Participants requiring non-steroidal anti-inflammatory drugs (NSAIDs) or aspirin treatment along with the concomitant PPI therapy to prevent gastrointestinal (GI) bleeding should not be enrolled.
14. Has Zollinger-Ellison syndrome or gastric acid hypersecretion or a history of gastric acid hypersecretion.
15. Is scheduled for surgery that requires hospitalization or requires surgical treatment during his/her participation in the study.
16. Has a history of malignancy or was treated for malignancy within 5 years before the start of the Screening Phase (visit 1) (the participant may be included in the study if he/she has cured cutaneous basal cell carcinoma or cervical carcinoma in situ).
17. Has acquired immunodeficiency syndrome (AIDS) or hepatitis, including hepatitis virus carriers (hepatitis B surface antigen \[HBsAg\] or hepatitis C virus (HCV)-antibody-positive) (the participant may be included in the study if he/she is HCV-antigen or HCV-ribonucleic acid \[RNA\]-negative).
18. Laboratory tests performed on visit 1 revealed any of the following abnormalities in the participant:

1. Creatinine levels: \>2 mg/dL (\>177 μmol/L).
2. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST), or total bilirubin levels: \> upper limit of normal (ULN).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director Clinical Science, MD

Role: STUDY_DIRECTOR

Takeda Development Center Asia, Pte Ltd.

Locations

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