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

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ClinicalTrials.gov Identifier: NCT03050307
Recruitment Status : Completed
First Posted : February 10, 2017
Last Update Posted : June 24, 2020
Sponsor:
Information provided by (Responsible Party):
Takeda

Brief 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.

Condition or disease Intervention/treatment Phase
Gastric Ulcer Peptic Ulcer Gastrointestinal Diseases Digestive System Diseases Lansoprazole Anti-Ulcer Agents Gastrointestinal Agents Proton Pump Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Drug: TAK-438 Drug: Lansoprazole Drug: TAK-438 Placebo Drug: Lansoprazole Placebo Drug: Bismuth-Containing Quadruple Therapy Phase 3

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 16 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 234 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Double-Blind, Double-Dummy, Phase 3 Study to Evaluate the Efficacy and Safety of Oral TAK-438 20mg Compared to Lansoprazole 30mg Once- or Twice-Daily in the Treatment of Endoscopically Confirmed Gastric Ulcer Subjects With or Without Helicobacter Pylori Infection
Actual Study Start Date : April 17, 2017
Actual Primary Completion Date : February 19, 2020
Actual Study Completion Date : May 26, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: TAK-438 20 mg (HP- Participants)
TAK-438 20 mg, tablet, orally, once daily and lansoprazole placebo-matching capsule, orally, once daily for up to 8 weeks.
Drug: TAK-438
TAK-438 tablets
Other Name: Vonoprazan

Drug: Lansoprazole Placebo
Lansoprazole placebo-matching capsules

Experimental: TAK-438 20 mg (HP+ Participants)
TAK-438 20 mg, tablet, orally, twice daily and lansoprazole placebo-matching capsule, orally, twice daily along with bismuth-containing quadruple therapy (amoxicillin 1 g, twice daily, clarithromycin 500 mg twice daily, and bismuth potassium citrate 600 mg [equivalent to 220 mg bismuth] twice daily) for first 2 weeks. TAK-438 20 mg, tablet, orally, once daily and lansoprazole placebo-matching capsule, orally, once daily for up to 6 weeks.
Drug: TAK-438
TAK-438 tablets
Other Name: Vonoprazan

Drug: Lansoprazole Placebo
Lansoprazole placebo-matching capsules

Drug: Bismuth-Containing Quadruple Therapy
Bismuth-Containing Quadruple Therapy

Active Comparator: Lansoprazole 30 mg (HP- Participants)
Lansoprazole 30 mg, capsule, orally, once daily and TAK-438 placebo-matching tablet, orally, once daily for up to 8 weeks.
Drug: Lansoprazole
Lansoprazole capsules
Other Name: Prevacid

Drug: TAK-438 Placebo
TAK-438 placebo-matching tablets

Active Comparator: Lansoprazole 30 mg (HP+ Participants)
Lansoprazole 30 mg, capsule, orally, twice daily and TAK-438 placebo-matching tablet, orally, twice daily along with bismuth-containing quadruple therapy (amoxicillin 1 g, twice daily, clarithromycin 500 mg, twice daily, and bismuth potassium citrate 600 mg [equivalent to 220 mg bismuth] twice daily) for first 2 weeks. Lansoprazole 30 mg, capsule, orally, once daily and TAK-438 placebo-matching tablet, orally, once daily for up to 6 weeks.
Drug: Lansoprazole
Lansoprazole capsules
Other Name: Prevacid

Drug: TAK-438 Placebo
TAK-438 placebo-matching tablets

Drug: Bismuth-Containing Quadruple Therapy
Bismuth-Containing Quadruple Therapy




Primary Outcome Measures :
  1. Percentage of Participants with Endoscopically Confirmed Healing of Gastric Ulcer(s) at Week 4 or 8 [ Time Frame: Week 4 or 8 ]
    Rate of Endoscopic healing is defined as the percentage of participants in whom the disappearance of all white coats associated with gastric ulcers has been endoscopically confirmed.


Secondary Outcome Measures :
  1. Percentage of Helicobacter Pylori Infected (HP+) Participants with Successful Helicobacter Pylori Eradication After 4 or 8 Weeks of Treatment [ Time Frame: After 4 or 8 weeks of treatment (up to 16 weeks) ]
    HP infection status will be determined by ^13C Urea Breath Test (^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.

  2. Percentage of Participants with Endoscopically Confirmed Healing of Gastric Ulcer at Week 4 [ Time Frame: Week 4 ]
    Rate of Endoscopic healing is defined as the percentage of participants in whom the disappearance of all white coats associated with gastric ulcers has been endoscopically confirmed.

  3. Percentage of Participants with Posttreatment Resolution of Gastrointestinal Symptoms Associated with Gastric Ulcer at Weeks 2 through 8 [ Time Frame: Week 2 up to Week 8 ]
    Gastrointestinal symptoms are defined as: epigastric pain (postprandial, fasting, nocturnal), abdominal bloating, nausea, heartburn and lack of appetite.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

  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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03050307


Locations
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Sponsors and Collaborators
Takeda
Investigators
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Study Director: Medical Director Clinical Science Takeda
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Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT03050307    
Other Study ID Numbers: TAK-438_302
U1111-1138-8706 ( Other Identifier: WHO )
CTR20170100 ( Registry Identifier: CFDA )
First Posted: February 10, 2017    Key Record Dates
Last Update Posted: June 24, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Takeda:
Drug therapy
Additional relevant MeSH terms:
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Peptic Ulcer
Gastrointestinal Diseases
Stomach Ulcer
Ulcer
Digestive System Diseases
Pathologic Processes
Duodenal Diseases
Intestinal Diseases
Stomach Diseases
Lansoprazole
Dexlansoprazole
Bismuth
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antacids