Efficacy and Safety of Vonoprazan Compared to Lansoprazole in the Maintenance Treatment of Erosive Esophagitis
Information source: Takeda
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Erosive Esophagitis
Intervention: Vonoprazan (Drug); Lansoprazole (Drug); Vonoprazan Placebo (Drug); Lansoprazole Placebo (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Takeda Official(s) and/or principal investigator(s): Medical Director Clinical Science, MD, Study Director, Affiliation: Takeda Development Center Asia, Pte Ltd.
Overall contact: Takeda Study Registration Call Center, Phone: 800- 778-2860, Email: medicalinformation@tpna.com
Summary
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.
Clinical Details
Official title: A Randomized, Double-Blind, Double-Dummy, Parallel-group Phase 3 Study to Evaluate the Efficacy and Safety of Oral Once-Daily Administration of TAK-438, 10 or 20 mg Compared to Lansoprazole 15 mg in the Maintenance Treatment of Subjects With Endoscopic Healing of Erosive Esophagitis
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Percentage of Participants with Recurrence of Erosive Esophagitis as Confirmed on Endoscopy after the 24-week Maintenance Phase
Secondary outcome: Percentage of Participants with Recurrence of Erosive Esophagitis after 12 Weeks of Treatment in the Maintenance PhaseNumber and Percentage of Participants With Adverse Events (AE) Number and Percentage of Participants With Abnormal Clinical Laboratory Findings Number and Percentage of Participants With Abnormal Electrocardiogram (ECG) Findings Number and Percentage of Participants With Abnormal Vital Sign Measurements Change from Baseline in Serum Gastrin Change from Baseline in Serum Pepsinogen I Change from Baseline in Serum Pepsinogen II
Detailed description:
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 600 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
All participants 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 6 months. Participants will make 5 visits to the clinic, and will be contacted by
telephone 7-14 days after last dose of study drug for a follow-up assessment.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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 (LA classification
grades A to D) within 84 days of Day 1.
4. 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 1
week, otherwise the endoscopy must be repeated to confirm healing before
randomization in the TAK-438_305 study.
5. 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.
6. 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.
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).
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:
- I. Creatinine levels: >2 mg/dL (>177 μmol/L).
- ii. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels:
>2. 5 times the upper limit of normal (ULN).
- iii. Total bilirubin levels: >2 times the upper limit of normal (ULN).
Locations and Contacts
Takeda Study Registration Call Center, Phone: 800- 778-2860, Email: medicalinformation@tpna.com
Beijing, China; Recruiting
Tianjing, China; Recruiting
Additional Information
Starting date: April 2015
Last updated: July 5, 2015
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