Erosive Esophagitis Clinical Trial
Official title:
A Randomized, Double-Blind, Double-Dummy Phase 3 Study to Evaluate the Efficacy and Safety of Oral Once-Daily Administration of TAK-438 20 mg Compared to Lansoprazole 30 mg in the Treatment of Subjects With Erosive Esophagitis
Verified date | February 2019 |
Source | Takeda |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 481 |
Est. completion date | July 27, 2017 |
Est. primary completion date | July 27, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 in an endoscopy to have erosive esophagitis, ie, the Los Angeles (LA) classification grades A to D within 7 days of the start of the Day 1 (Visit 2). Note: The recruitment goal is to ensure that those with LA classification grade C/D will account for more than 30% of all participants enrolled (144/480), with no further recruitment of those with grade A/B considered when they account for more than 70% (336/480) of all participants. 4. 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 admitted temporarily for examination. 5. 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 within 84 days prior to the start of the Observation phase. 2. Has received TAK-438 in a previous clinical study or as a therapeutic agent. 3. Is an immediate family member, study site employee, or is in a dependant 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 serious central nerve system (CNS), cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urological, endocrine or hematological disease. 6. Has a history of hypersensitivity or allergies to TAK-438 (including its excipients*) or to proton pump inhibitors (PPIs). *D-mannitol, crystalline cellulose, hydroxypropyl cellulose, fumaric acid, croscarmellose sodium, magnesium stearate, hypromellose, macrogol 6000, titanium oxide, yellow iron sesquioxide and iron sesquioxide. 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 Observation Phase (Visit 1). 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 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 Observation 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 Observation 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) positive, 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 at the start of the Early Observation Phase (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). 19. Is active in the Screening Period after the closure of enrollment identified by the Sponsor or the number of participants randomized with LA classification A/B or C/D have reached the required sample size. |
Country | Name | City | State |
---|---|---|---|
China | Beijing Chao Yang Hospital | Beijing | Beijing |
China | Beijing Friendship Hospital, Capital Medical University | Beijing | |
China | Beijing Tongren Hospital, Capital Medical Univeristy | Beijing | Beijing |
China | China-Japan Friendship hospital | Beijing | Beijing |
China | Peking Union Medical College Hospital | Beijing | Beijing |
China | PLA.The Military General Hospital of Beijing | Beijing | Beijing |
China | No.2 Hospital Affiliated to Jilin University | Changchun | Jilin |
China | The 2nd Xiangya Hospital Central South University | Changsha | Hunan |
China | The First People's Hospital of Changzhou | Changzhou City | Jiangsu |
China | Chenzhou No.1 People's Hospital | Chenzhou | Hunan |
China | The Second Affiliated Hospital of Chongqing Medical University | Chongqing | |
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 | 1st Affiliated Hospital of Zhejiang University | Hangzhou | |
China | 2nd Affiliated Hospital, Zhejiang Univ. School of Medicine | Hangzhou | Zhejiang |
China | Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine | Hangzhou | Zhejiang |
China | Jilin central Hospital | Jilin | Jilin |
China | The First Affiated Hospital of Kunming Medical College | Kunming | Yunnan |
China | The First Affiliated Hospital of NanChang University | Nanchang | |
China | Jiangsu Province People's Hospital | Nanjing | Jiangsu |
China | The Affiliated DrumTower Hospital of Nanjing University | Nanjing | |
China | Ruijin Hospital, Shanghai Jiaotong Uni. School of Med. | Shanghai | Shanghai |
China | TongJi Hospital of Tongji University | Shanghai | Shanghai |
China | Zhongshan Hospital Fudan University | Shanghai | Shanghai |
China | The 2nd Hospital of Tianjin Medical University | Tianjin | Tianjin |
China | Tianjin Medical University General Hospital | Tianjin | Tianjin |
China | Tongji Hospital, Tongji Medical College, Huazhong University of Science & Techology | Wuhan | Hubei |
China | Union Hospital of Tongji Medical College of Huazhong Science and Techology University | Wuhan | Hubei |
China | General Hospital of Ningxia Medical University | Yinchuan | Ningxia |
Korea, Republic of | Pusan National University Hospital | Busan | |
Korea, Republic of | Kyungpook National University Medical Center | Daegu | Gyeongsangbuk-do |
Korea, Republic of | Yeungnam University Hospital | Daegu | |
Korea, Republic of | Wonkwang University School Of Medicine & Hospital | Iksan-si | Jeollabuk-do |
Korea, Republic of | Seoul National University Bundang Hospital | Seongnam-si | Gyeonggi-do |
Korea, Republic of | Asan Medical Center | Seoul | |
Korea, Republic of | Kangbuk Samsung Hospital | Seoul | |
Korea, Republic of | Korea University Anam Hospital | Seoul | |
Korea, Republic of | Kyung Hee University Hospital | Seoul | |
Korea, Republic of | Samsung Medical Center | Seoul | |
Korea, Republic of | Seoul National University Hospital | Seoul | Gyeonggi-do |
Korea, Republic of | The Catholic University of Korea, Seoul St. Marys Hospital | Seoul | |
Malaysia | Hospital Sultana Bahiyah | Alor Setar | Kedah |
Malaysia | Hospital Ampang | Ampang | Selangor |
Malaysia | Hospital Universiti Sains Malaysia | Kelantan | |
Malaysia | Hospital Raja Perempuan Zainab II | Kota Bahru | Kelantan |
Malaysia | Hospital Queen Elizabeth | Kota Kinabalu | Sabah |
Malaysia | Hospital Kuala Lumpur | Kuala Lumpur | |
Malaysia | University Malaya Medical Centre | Kuala Lumpur | |
Malaysia | Hospital Tengku Ampuan Afzan | Kuantan | Pahang |
Taiwan | E-Da Hospital | Kaohsiung | |
Taiwan | Kaohsiung Chang Gung Memorial Hospital | Kaohsiung | |
Taiwan | Kaohsiung Medical University Chung-Ho Memorial Hospital | Kaohsiung | |
Taiwan | Cheng Ching General Hospital-Chung Kang Branch | Taichung | |
Taiwan | China Medical University Hospital | Taichung | |
Taiwan | Chung Shan Medical University Hospital | Taichung | |
Taiwan | National Cheng Kung University Hospital | Tainan | |
Taiwan | National Taiwan University Hospital | Taipei | |
Taiwan | Taipei Veterans General Hospital | Taipei | |
Taiwan | Tri-Service General Hospital | Taipei | |
Taiwan | Taipei Medical University Hospital | Taipei City | |
Taiwan | Chang Gung Memorial Hospital, Linkou | Taoyuan County |
Lead Sponsor | Collaborator |
---|---|
Takeda |
China, Korea, Republic of, Malaysia, Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 8 weeks | |
Secondary | 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. | Week 2 and Week 4 | |
Secondary | 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. | On or after the start of study drug (Day 1) to 14 days after the last dose of study medication (up to 10 weeks) | |
Secondary | 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. | From Day 1 to 14 days after the last dose of study medication (up to 10 weeks) | |
Secondary | 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. | From Day 1 to 14 days after the last dose of study medication (up to 10 weeks) | |
Secondary | 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. | From Day 1 to 14 days after the last dose of study medication (up to 10 weeks) | |
Secondary | Change From Baseline in Serum Gastrin | The change between the serum gastrin values collected at Weeks 2, 4, and 8 relative to baseline. | Baseline and Weeks 2, 4, and 8 | |
Secondary | 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. | Baseline and Weeks 2, 4, and 8 | |
Secondary | 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. | Baseline and Weeks 2, 4, and 8 |
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