The purpose of the study is to demonstrate the efficacy of vonoprazan (TAK-438) versus lansoprazole in the treatment of erosive esophagitis classified as Los Angeles (LA) classification grades A to D at Week 8.
The drug being tested in this study is called vonoprazan. Vonoprazan is being tested to treat people who have erosive esophagitis. This study will look at mucosal healing of people who take vonoprazan versus lansoprazole. This study will enroll approximately 480 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups-which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need): * Vonoprazan 20 mg * Lansoprazole 30 mg All participants will be asked to take one tablet and one capsule at the same time each day 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-center trial will be conducted worldwide. The overall time to participate in this study is up to 11 weeks. 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
481
Vonoprazan tablets
Lansoprazole capsules
Vonoprazan placebo-matching tablets
Percentage of Participants With Endoscopic Healing of Erosive Esophagitis During the 8-Week Treatment Phase
Endoscopic healing is defined as participants endoscopically diagnosed as Los Angeles classification grade O during the treatment phase. Grade O indicates there are no mucosal breaks in the mucosa.
Time frame: 8 weeks
Percentage of Participants With Endoscopic Healing of Erosive Esophagitis After 2 Weeks and 4 Weeks of Treatment
Endoscopic healing is defined as participants endoscopically diagnosed as Los Angeles classification grade O during the treatment phase. Grade O indicates there are no mucosal breaks in the mucosa.
Time frame: Week 2 and Week 4
Number of Participants Reporting Who Had One or More Treatment-emergent Adverse Event (TEAE)
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product; 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.
Time frame: On or after the start of study drug (Day 1) to 14 days after the last dose of study medication (up to 10 weeks)
Number of Participants With Markedly Abnormal Clinical Laboratory Findings
Clinical Laboratory Safety tests included Chemistry, Hematology and Urinalysis. Number of participants with any markedly abnormal values in laboratory tests collected throughout study is reported. ALT = alanine aminotransferase, AST = aspartate aminotransferase, GGT = gamma-glutamyl transferase, CPK = creatine phosphokinase, BUN = blood urea nitrogen, LLN = lower limit of normal or lower reference limit, ULN = upper limit of normal or upper reference limit, g/L = grams per liter, U/L = units per liter, mmol/L = millimoles per liter, pmol/L = picomoles per liter.
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Lansoprazole placebo-matching capsules
Beijing Chao Yang Hospital
Beijing, Beijing Municipality, China
China-Japan Friendship hospital
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Beijing Tongren Hospital, Capital Medical Univeristy
Beijing, Beijing Municipality, China
PLA.The Military General Hospital of Beijing
Beijing, Beijing Municipality, China
Fuzhou General Hospital of Nanjing Military Command
Fuzhou, Fujian, China
Guangdong General Hospital
Guangzhou, Guangdong, China
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
The 2nd Xiangya Hospital Central South University
Changsha, Hu'nan, China
Chenzhou No.1 People's Hospital
Chenzhou, Hu'nan, China
...and 54 more locations
Time frame: From Day 1 to 14 days after the last dose of study medication (up to 10 weeks)
Number of Participants With Markedly Abnormal Electrocardiogram (ECG) Findings
Number of participants with any markedly abnormal 12-lead ECG findings is reported. bpm = beats per minute, msec = milliseconds, CHG= change from baseline.
Time frame: From Day 1 to 14 days after the last dose of study medication (up to 10 weeks)
Number of Participants With Markedly Abnormal Vital Sign Measurements
Number of participants with any markedly abnormal vital signs measurements is reported. Vital signs included body temperature (oral, tympanic, or infra-axillary measurement), sitting blood pressure (5 minutes), and pulse. °C = degrees Celsius, mmHg = millimeters of mercury, bpm = beats per minute.
Time frame: From Day 1 to 14 days after the last dose of study medication (up to 10 weeks)
Change From Baseline in Serum Gastrin
The change between the serum gastrin values collected at Weeks 2, 4, and 8 relative to baseline.
Time frame: Baseline and Weeks 2, 4, and 8
Change From Baseline in Serum Pepsinogen I
The change between the serum pepsinogen I values collected at Weeks 2, 4, and 8 relative to baseline.
Time frame: Baseline and Weeks 2, 4, and 8
Change From Baseline in Serum Pepsinogen II
The change between the serum pepsinogen II values collected at Weeks 2, 4, and 8 relative to baseline.
Time frame: Baseline and Weeks 2, 4, and 8