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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02388724
Other study ID # TAK-438_303
Secondary ID U1111-1138-4788C
Status Completed
Phase Phase 3
First received
Last updated
Start date March 24, 2015
Est. completion date July 27, 2017

Study information

Verified date February 2019
Source Takeda
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Vonoprazan
Vonoprazan tablets
Lansoprazole
Lansoprazole capsules
Vonoprazan Placebo
Vonoprazan placebo-matching tablets
Lansoprazole Placebo
Lansoprazole placebo-matching capsules

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Takeda

Countries where clinical trial is conducted

China,  Korea, Republic of,  Malaysia,  Taiwan, 

Outcome

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
See also
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