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CompletedNCT03050307Updated Jun 18, 2021Results posted

Comparison of TAK-438 (Vonoprazan) to Lansoprazole in the Treatment of Gastric Ulcer Participants With or Without Helicobacter Pylori Infection

A Phase 3 interventional study of TAK-438 and Lansoprazole in Gastric Ulcer, sponsored by Takeda. Completed at 81 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-06-18.

Sponsored by Takeda · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
234
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to demonstrate the non-inferior efficacy of TAK-438 versus lansoprazole in the treatment of participants with gastric ulcer.

Read the detailed description

The drug being tested in this study is called TAK-438. TAK-438 is being tested to treat people who have stomach ulcers and also may or may not have Helicobacter pylori (HP) infection. This study will look at stomach ulcer healing and also the elimination of HP in people who take TAK-438 versus lansoprazole.

The study will enroll approximately 830 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 participants and study doctor during the study (unless there is an urgent medical need):

  • TAK-438 20 mg
  • Lansoprazole 30 mg

Study treatment will depend upon the Helicobacter pylori infection status of the participant, and include bismuth-containing quadruple therapy for the first 2 weeks in H pylori infected (HP+) participants. HP+ participants will be asked to take a TAK- 438 tablet or a lansoprazole capsule twice daily in conjunction with bismuth-containing quadruple therapy for 2 weeks, followed up by a TAK-438 tablet or a lansoprazole capsule once daily for up to 6 weeks. HP- participants will be asked to take a TAK-438 tablet or a lansoprazole capsule once daily for up to 8 weeks.

This multi-center trial will be conducted in China, Korea, Taiwan, and Philippines. The overall time to participate in this study is up to 12 weeks. Participants will make multiple visits plus final visit at 2 weeks or 4 weeks after last dose of study drug for a follow-up assessment.

02

Conditions studied

  • Gastric Ulcer

Keywords

  • Drug therapy
03

In context

Stomach Ulcer

112 studies on the registry are indexed under Stomach Ulcer; 13 are open to participants now.

This study's enrollment of 234 is below the median of 265 across 86 interventional studies indexed under Stomach Ulcer.

Browse Stomach Ulcer studies →

Lead sponsor

Takeda is the lead sponsor of 1,002 studies on the registry; 92 are open to participants now.

Of its 173 completed or terminated interventional studies of FDA-regulated products, 149 (86%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Has endoscopic evidence of active gastric ulcer(s) (i.e. mucosal defects with white coating [including cases associated with blood coagula as long as there is no active bleeding]) measuring 5 mm or larger in longest diameter within 14 days prior to randomization.

Exclusion criteria

Exclusion Criteria:

  1. Has received TAK-438 in a previous clinical study or as a therapeutic agent.
  2. Has a history or clinical manifestations of significant central nervous system (CNS), cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urological, endocrine or hematological disease that, in the opinion of the investigator, would confound the study results or compromise participant safety.
  3. Has been treated with Helicobacter pylori eradication therapy within 30 days prior to study treatment.
  4. Has any gastric ulcer of >2 cm in any diameter or with >3 separate gastric ulcers in total as evident by endoscopy within 14 days prior to randomization.
  5. Has a diagnosis of gastric malignancy or a gastric ulcer whose morphology suggested malignancy as evident by endoscopy within 14 days prior to randomization.
  6. Is suspected of having acute gastro-duodenal mucosal lesions (AGDML) as evident by endoscopy within 14 days prior to randomization.
  7. Has a linear ulcer (including a linear ulcer scar) that has been confirmed by endoscopy within 14 days prior to randomization.
  8. Has active postoperative (e.g. endoscopic mucosal resection/endoscopic submucosal dissection) ulcer(s) as confirmed by endoscopy within 14 days prior to randomization.
  9. Has duodenal ulcer that has been confirmed by endoscopy within 14 days prior to randomization.
  10. Has ulcers for which medical therapy alone is not indicated (e.g., perforation, pyloric stenosis, duodenal stenosis, major bleeding).
  11. Has undergone therapeutic upper gastrointestinal (GI) endoscopic therapy (e.g., endoscopic hemostasis or excision including biopsy) within 30 days prior to visit 1.
  12. Has Zollinger-Ellison syndrome or gastric acid hypersecretion or those with a history of gastric acid hypersecretion.
  13. Has undergone major surgical procedures within 30 days prior to Visit 1 or are scheduled to undergo surgical procedures that may affect gastric acid secretion (e.g., abdominal surgery, vagotomy or craniotomy).
  14. Has a history of malignancy or was treated for malignancy within 5 years before the start of the visit 1 (the participant may be included in the study if he/she has cured cutaneous basal cell carcinoma or cervical carcinoma in situ).
  15. Has a known acquired immunodeficiency syndrome or hepatitis infection, 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-viral load-RNA-negative).

  16. Laboratory tests performed prior to randomization 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).
  17. Has hypersensitivity to TAK-438, proton pump inhibitors (PPIs), bismuth, clarithromycin, or amoxicillin. Skin testing may be performed according to local standard practice (for HP+ participants only).
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
234 participants (actual)

Study arms

  • Experimental
    TAK-438 20 mg

    Helicobacter Pylori positive (HP+) participants: TAK-438 20 mg tablet, twice daily (BID) along with lansoprazole placebo-matching, capsule BID in addition to bismuth-containing quadruple antibiotic therapy for the first 2 weeks. Following 2 weeks of eradication therapy participants received TAK-438 20 mg QD along with lansoprazole matching placebo 30 mg, capsule QD for up to 6 weeks. HP negative (HP-) participants: TAK-438 20 mg tablet, (QD) along with lansoprazole matching placebo, 30 mg capsule QD for up to 8 weeks.

    Drug: TAK-438 · Drug: Lansoprazole Placebo · Drug: Bismuth-Containing Quadruple Therapy

  • Experimental
    Lansoprazole 30 mg

    HP+ participants: Lansoprazole 30 mg, capsule, orally, BID and TAK-438 placebo-matching tablet, orally, BID along with bismuth-containing quadruple antibiotic therapy for first 2 weeks. Following 2 weeks participants received Lansoprazole 30 mg, capsule, orally, QD along with TAK-438 placebo-matching tablet, orally, QD for up to 6 weeks. HP- participants: Lansoprazole 30 mg, capsule, orally, QD along with TAK-438 placebo-matching tablet, orally, QD for up to 8 weeks.

    Drug: Lansoprazole · Drug: TAK-438 Placebo · Drug: Bismuth-Containing Quadruple Therapy

Interventions

  • DrugTAK-438

    TAK-438 tablets

    Also known as: Vonoprazan

  • DrugLansoprazole

    Lansoprazole capsules

    Also known as: Prevacid

  • DrugTAK-438 Placebo

    TAK-438 placebo-matching tablets

  • DrugLansoprazole Placebo

    Lansoprazole placebo-matching capsules

  • DrugBismuth-Containing Quadruple Therapy

    1 g Amoxicillin, 500 mg clarithromycin and 600 mg bismuth potassium citrate/bismuth tripotassium dicitrate, twice daily (BID).

06

What researchers measure

Primary outcomes

  1. Percentage of Participants With Endoscopically Confirmed Healing of Gastric Ulcers (GUs) at Weeks 4 or 8

    Endoscopic healing was defined as the disappearance of all white coats associated with GUs confirmed endoscopically.

    Time frame: Week 4 or 8

Secondary outcomes

  1. Percentage of Helicobacter Pylori Infected (HP+) Participants With Successful HP Eradication After 4 or 8 Weeks of Treatment

    HP infection status was determined by 13C-UBT. The urea breath test is used to detect infection with HP, a bacteria associated with stomach ulcers, by testing individual breath samples in a central laboratory. The data is provided only for HP+ participants. The participant could take 4 or 8 weeks of treatment for GU healing, then additional 4 weeks later, to have the urea breath test (UBT) test to detect HP.

    Time frame: 4 weeks post treatment (up to approximately 12 weeks)

  2. Percentage of Participants With Endoscopically Confirmed Healing of GU at Week 4

    Endoscopic healing was defined as the disappearance of all white coats associated with GUs confirmed endoscopically.

    Time frame: Week 4

  3. Percentage of Participants With Post-treatment Resolution of Gastrointestinal Symptoms Associated With GU

    The gastrointestinal symptoms included epigastric pain \[postprandial, fasting, nocturnal\], abdominal bloating, nausea/vomiting, heartburn, lack of appetite. The severity of gastrointestinal symptoms associated with GU were recorded as: none = 0, mild = 1, moderate = 2 or severe = 3. The data is reported in categories for percentage of participants with resolution of gastrointestinal symptoms associated with GU.

    Time frame: Week 2 up to Week 8

07

Results

Posted Jun 18, 2021

Participant flow

Participants took part in the study at 60 investigative sites in China, Korea, and Taiwan from 17 April 2017 to 26 May 2020.

Participant flow — Overall Study
MilestoneTAK-438 20 mgLansoprazole 30 mg
Started115119
Completed107110
Not completed89
Withdrew: Adverse event42
Withdrew: Significant protocol deviation01
Withdrew: Lost to follow-up01
Withdrew: Voluntary withdrawal34
Withdrew: Reason not specified11

Outcome measures

PrimaryPercentage of Participants With Endoscopically Confirmed Healing of Gastric Ulcers (GUs) at Weeks 4 or 8

Endoscopic healing was defined as the disappearance of all white coats associated with GUs confirmed endoscopically.

Time frame:
Week 4 or 8
Reported as:
Number · percentage of participants
Percentage of Participants With Endoscopically Confirmed Healing of Gastric Ulcers (GUs) at Weeks 4 or 8
percentage of participantsTAK-438 20 mgLansoprazole 30 mg
Percentage of Participants With Endoscopically Confirmed Healing of Gastric Ulcers (GUs) at Weeks 4 or 891.1 (84.193 to 95.635)94.7 (88.896 to 98.044)
Statistical analysis
  • TAK-438 20 mg vs Lansoprazole 30 mg · Exact (clopper-pearson): -3.7 · 95% CI -10.966 to 3.339
SecondaryPercentage of Helicobacter Pylori Infected (HP+) Participants With Successful HP Eradication After 4 or 8 Weeks of Treatment

HP infection status was determined by 13C-UBT. The urea breath test is used to detect infection with HP, a bacteria associated with stomach ulcers, by testing individual breath samples in a central laboratory. The data is provided only for HP+ participants. The participant could take 4 or 8 weeks of treatment for GU healing, then additional 4 weeks later, to have the urea breath test (UBT) test to detect HP.

Time frame:
4 weeks post treatment (up to approximately 12 weeks)
Reported as:
Number · percentage of participants
Percentage of Helicobacter Pylori Infected (HP+) Participants With Successful HP Eradication After 4 or 8 Weeks of Treatment
percentage of participantsTAK-438 20 mgLansoprazole 30 mg
Percentage of Helicobacter Pylori Infected (HP+) Participants With Successful HP Eradication After 4 or 8 Weeks of Treatment88.0 (78.439 to 94.363)80.8 (69.921 to 89.099)
Statistical analysis
  • TAK-438 20 mg vs Lansoprazole 30 mg · Exact (clopper-pearson): 7.2 · 95% CI -4.469 to 18.825
SecondaryPercentage of Participants With Endoscopically Confirmed Healing of GU at Week 4

Endoscopic healing was defined as the disappearance of all white coats associated with GUs confirmed endoscopically.

Time frame:
Week 4
Reported as:
Number · percentage of participants
Percentage of Participants With Endoscopically Confirmed Healing of GU at Week 4
percentage of participantsTAK-438 20 mgLansoprazole 30 mg
Percentage of Participants With Endoscopically Confirmed Healing of GU at Week 476.1 (67.035 to 83.788)82.1 (73.777 to 88.738)
Statistical analysis
  • TAK-438 20 mg vs Lansoprazole 30 mg · Exact (clopper-pearson): -6.0 · 95% CI -16.644 to 4.741
SecondaryPercentage of Participants With Post-treatment Resolution of Gastrointestinal Symptoms Associated With GU

The gastrointestinal symptoms included epigastric pain \[postprandial, fasting, nocturnal\], abdominal bloating, nausea/vomiting, heartburn, lack of appetite. The severity of gastrointestinal symptoms associated with GU were recorded as: none = 0, mild = 1, moderate = 2 or severe = 3. The data is reported in categories for percentage of participants with resolution of gastrointestinal symptoms associated with GU.

Time frame:
Week 2 up to Week 8
Reported as:
Number · percentage of participants
Percentage of Participants With Post-treatment Resolution of Gastrointestinal Symptoms Associated With GU
percentage of participantsTAK-438 20 mgLansoprazole 30 mg
Epigastric Pain (Postprandial)78.9 (54.435 to 93.948)80.0 (59.296 to 93.169)
Epigastric Pain (Fasting/Nocturnal)85.0 (70.165 to 94.290)80.5 (65.133 to 91.179)
Abdominal Bloating81.3 (54.354 to 95.953)65.2 (42.734 to 83.624)
Nausea/Vomiting100.0 (100.0 to 100.0)100.0 (100.0 to 100.0)
Heartburn95.8 (78.880 to 99.895)85.7 (67.335 to 95.966)
Lack of Appetite77.8 (39.991 to 97.186)90.0 (55.498 to 99.747)
Statistical analysis
  • TAK-438 20 mg vs Lansoprazole 30 mg · Exact (clopper-pearson): -1.1 · 95% CI -25.175 to 23.070
  • TAK-438 20 mg · Exact (clopper-pearson): 4.5 · 95% CI -11.907 to 20.931
  • TAK-438 20 mg vs Lansoprazole 30 mg · Exact (clopper-pearson): 16.0 · 95% CI -11.255 to 43.321
  • TAK-438 20 mg vs Lansoprazole 30 mg · Exact (clopper-pearson): 10.1 · 95% CI -5.109 to 25.348
  • TAK-438 20 mg vs Lansoprazole 30 mg · Exact (clopper-pearson): -12.2 · 95% CI -45.138 to 20.694

Adverse events

Collected over From first dose up to 4 weeks post dose (up to approximately 12 weeks). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
TAK-438 20 mg0/115 (0%)3/115 (2.6%)43/115 (37.4%)
Lansoprazole 30 mg0/119 (0%)2/119 (1.7%)15/119 (12.6%)
Most frequent serious events
Most frequent serious events
EventTAK-438 20 mgLansoprazole 30 mg
AppendicitisInfections and infestations1/1150/119
MeningitisInfections and infestations1/1150/119
Gastric cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)1/1150/119
Angina pectorisCardiac disorders0/1151/119
Liver abscessInfections and infestations0/1151/119
Most frequent other events
Most frequent other events
EventTAK-438 20 mgLansoprazole 30 mg
Pepsinogen test positiveInvestigations29/1156/119
Blood gastrin increasedInvestigations24/1155/119
Pepsinogen I increasedInvestigations23/1158/119
DysgeusiaNervous system disorders2/1157/119
Alanine aminotransferase increasedInvestigations6/1153/119

Baseline characteristics

All Randomized Participants.

Age, Continuous
Age, Continuous(years)TAK-438 20 mgLansoprazole 30 mgTotal
Mean54.0 ± 13.6853.5 ± 13.3753.7 ± 13.50
Sex: Female, Male
Sex: Female, Male(Participants)TAK-438 20 mgLansoprazole 30 mgTotal
Female292756
Male8692178
Race (NIH/OMB)
Race (NIH/OMB)(Participants)TAK-438 20 mgLansoprazole 30 mgTotal
American Indian or Alaska Native000
Asian114119233
Native Hawaiian or Other Pacific Islander000
Black or African American000
White000
More than one race101
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(Participants)TAK-438 20 mgLansoprazole 30 mgTotal
China6571136
Korea, Republic Of444286
Taiwan, Province Of China6612
Height
Height(cm)TAK-438 20 mgLansoprazole 30 mgTotal
Mean165.4 ± 7.49167.1 ± 7.96166.2 ± 7.76
Weight
Weight(kg)TAK-438 20 mgLansoprazole 30 mgTotal
Mean63.76 ± 10.74366.83 ± 11.37065.32 ± 11.149
Body Mass Index
Body Mass Index(kg/m^2)TAK-438 20 mgLansoprazole 30 mgTotal
Mean23.25 ± 3.22423.85 ± 3.25523.56 ± 3.247
Smoking classification
Smoking classification(Participants)TAK-438 20 mgLansoprazole 30 mgTotal
The Participant has Never Smoked4952101
The Participant is a Current Smoker5051101
The Participant is an Ex-smoker161632

12 further baseline measures are reported on the registry.

08

Study locations

81 sites
  • The First Affiliated Hospital of Anhui Medical University
    Hefei, Anhui 230024, China
  • Yijishan hospital of Wan nan Medical college
    Wuhu, Anhui 241001, China
  • Peking University First Hospital
    Beijing,P.R., Beijing 100034, China
  • Beijing Chao Yang Hospital
    Beijing, Beijing 100020, China
  • The General Hospital of People's Armed Police Forces China
    Beijing, Beijing 100039, China
  • The Central Hospital of China Aerospace Corporation
    Beijing, Beijing 100049, China
  • Beijing Friendship Hospital, Capital Medical University
    Beijing, Beijing 100050, China
  • Beijing Tong Ren Hospital, Capital Medical University
    Beijing, Beijing 100730, China
  • The Second Affiliated Hospital of Chongqing Medical University
    Chongqing, Chongqing 40010, China
  • Fuzhou General Hospital of Nanjing Military Area Command of Chinese PLA
    Fuzhou, Fujian 350025, China
  • The First Affiliated Hospital of Xiamen University
    Xiamen, Fujian 361003, China
  • Zhangzhou Hospital
    Zhangzhou, Fujian 363000, China
  • The First People's Hospital of Foshan
    Foshan, Guangdong 528000, China
  • Guangdong General Hospital
    Guangzhou, Guangdong 510080, China
  • The Sixth Affiliated Hospital of Sun Yat-Sen University
    Guangzhou, Guangdong 510655, China
  • Peking University Shenzhen Hospital
    Shenzhen, Guangdong 518000, China
  • Haikou People's Hospital
    Haikou, Hainan 570208, China
  • Shiyan Taihe Hospital
    Shiyan, Hebei 442000, China
  • Jingzhou Central Hospital
    Jingzhou, Hubei 434020, China
  • Union Hospital of Tongji Medical College of Huazhong Science and Techology University
    Wuhan, Hubei 420104, China
  • Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
    Wuhan, Hubei 430030, China
  • Wuhan General Hospital of Guangzhou Military
    Wuhan, Hubei 430070, China
  • The 2nd Xiangya Hospital Central South University
    Changsha, Hunan 410011, China
  • Chenzhou No.1 People's Hospital
    Chenzhou, Hunan 432000, China
  • Changsha Central Hospital
    Yuhua, Hunan 410018, China
  • The First People's Hospital of Changzhou
    Changzhou City, Jiangsu 213003, China
  • Nanjing First Hospital
    Nanjing, Jiangsu 210012, China
  • Wuxi 4th People's Hospital
    Wuxi, Jiangsu 214062, China
  • Wuxi People's Hospital
    Wuxi, Jiangsu 241023, China
  • Affiliated Hospital of Jiangsu University
    Zhenjiang, Jiangsu 212001, China
  • The First Affiliated Hospital of NanChang University
    Nanchang, Jiangxi 330006, China
  • Jiangxi Nanchang 3rd Hospital
    Nanchang, Jiangxi 330009, China
  • Jiangxi Pingxiang People's Hospital
    Pingxiang, Jiangxi 337055, China
  • The First Hospital of Jilin University
    Changchun, Jilin 130000, China
  • Jilin 4th People'S hospital
    Changchun, Jilin 130012, China
  • China-Japan Union Hospital of Jilin University
    Changchun, Jilin 130033, China
  • Jilin central Hospital
    Jilin, Jilin 132011, China
  • Jilin Siping Central Hospital
    Siping, Jilin 136000, China
  • General Hospital of Shenyang Military Region
    Shenyang, Liaoning 110016, China
  • General Hospital of Ningxia Medical University
    Yinchuan, Ningxia 750004, China
  • People's Hospital of Qinghai Province
    Xining, Qinghai 810007, China
  • Ruijin Hospital, Shanghai Jiaotong Uni. School of Med.
    Huangpu Qu, Shanghai 200020, China
  • Zhongshan Hospital Fudan University
    Shanghai, Shanghai 200032, China
  • Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
    Shanghai, Shanghai 200092, China
  • Shanghai Tongji Hospital
    Shanghai, Shanghai 200442, China
  • The 2nd Hospital of Xi An Jiaotong University
    Xi'an, Shanxi 710004, China
  • Tianjin Medical University Affiliated General Hospital
    Tianjin, Tianjin 300052, China
  • The First Affiliated Hospital of Kunming Medical College
    Kunming, Yunnan 650032, China
  • 1st Affiliated Hospital of Zhejiang University
    Hangzhou, Zhejiang 310003, China
  • Zhejiang Hospital
    Hangzhou, Zhejiang 310013, China
  • Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
    Hangzhou, Zhejiang 310016, China
  • The Second Affiliated Hospital of Wenzhou Medical College
    Wenzhou, Zhejiang 325027, China
  • The Second Affiliated Hospital Zhejiang University School of Medicine
    Hangzhou, 310009, China
  • Yonsei University Wonju Severance Christian Hospital
    Wonju-si, Gangwon-do 26426, Korea, Republic of
  • Korea University Ansan Hospital
    Ansan-si, Gyeonggi-do 15355, Korea, Republic of
  • The Catholic University of Korea, Bucheon St. Mary s Hospital
    Bucheon-si, Gyeonggi-do 14647, Korea, Republic of
  • Hanyang Univerisy Guri Hospital
    Guri-si, Gyeonggi-do 11923, Korea, Republic of
  • Seoul National University Bundang Hospital
    Seongnam-si, Gyeonggi-do 13620, Korea, Republic of
  • The Catholic University of Korea, St. Vincent's Hospital
    Suwon-si, Gyeonggi-do 16247, Korea, Republic of
  • Wonkwang University Hospital
    Iksan-si, Jeollabuk-do 54538, Korea, Republic of
  • Chonbuk National University Hospital
    Jeonju-si, Jeollabuk-do 54907, Korea, Republic of
  • Dong-A University Hospital
    Busan, 49201, Korea, Republic of
  • Kyungpook National University Hospital
    Daegu, 41944, Korea, Republic of
  • Yeungnam University Hospital
    Daegu, 42415, Korea, Republic of
  • Chonnam National University Hospital
    Gwangju, 61469, Korea, Republic of
  • The Catholic University of Korea, Incheon St. Mary's Hospital
    Incheon, 21431, Korea, Republic of
  • Gachon University Gil Medical Center
    Incheon, 21565, Korea, Republic of
  • Korea University Anam Hospital
    Seoul, 02841, Korea, Republic of
  • Kangbuk Samsung Hospital
    Seoul, 03181, Korea, Republic of
  • Severance Hospital, Yonsei University
    Seoul, 03722, Korea, Republic of
  • Cebu Doctors University Hospital
    Cebu City, 6000, Philippines
  • De La Salle University Medical Center
    Dasmarinas City, Cavite, 4114, Philippines
  • Davao Doctors Hospital
    Davao, 8000, Philippines
  • West Visayas State University Medical Center
    Iloilo City, 5000, Philippines
  • Philippine General Hospital
    Manila, 1000, Philippines
  • St. Luke's Medical Center Global City
    Taguig City, 1634, Philippines
  • China Medical University Hospital
    Taichung, 40447, Taiwan
  • National Taiwan University Hospital
    Taipei, 100, Taiwan
  • Taipei Veterans General Hospital
    Taipei, 11217, Taiwan
  • Tri-Service General Hospital
    Taipei, 11490, Taiwan
  • Chang Gung Memorial Hospital, Linkou
    Taoyuan County, 333, Taiwan
09

References and documents

Study documents

  • Study protocol · Dec 21, 2016
  • Statistical analysis plan · Jun 5, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

Supporting information: Study protocol, Sap, Icf, Csr

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 18, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03050307
Lead sponsor
Takeda
Responsible party
Sponsor
First posted
Feb 10, 2017
Start date
Apr 17, 2017
Primary completion
Feb 19, 2020
Completion
May 26, 2020
Results posted
Jun 18, 2021
Last update
Jun 18, 2021

Study contacts

Study Director Clinical Science
study director · Takeda

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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