Comparison of TAK-438 (Vonoprazan) to Lansoprazole in the Treatment of Duodenal Ulcer Participants With or Without Helicobacter Pylori Infection
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| ClinicalTrials.gov Identifier: NCT03050359 |
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Recruitment Status :
Completed
First Posted : February 10, 2017
Results First Posted : June 12, 2020
Last Update Posted : June 12, 2020
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Sponsor:
Takeda
Information provided by (Responsible Party):
Takeda
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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 duodenal ulcer.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Duodenal Ulcer | Drug: TAK-438 Drug: Lansoprazole Drug: TAK-438 Placebo Drug: Lansoprazole Placebo Drug: Bismuth-Containing Quadruple Therapy | Phase 3 |
The drug being tested in this study is called TAK-438. TAK-438 is being tested to treat people who have duodenal ulcers and also may or may not have Helicobacter pylori (HP) infection. This study will look at duodenal ulcer healing and also the elimination of HP in people who take TAK-438 versus lansoprazole. The study will enroll approximately 530 patients.
Participants were randomly assigned (by chance, like flipping a coin) to one of the two treatment groups-which remained undisclosed to the participant and study doctor during the study (unless there is an urgent medical need):
- TAK-438 20 mg
- Lansoprazole 30 mg
HP+ participants will be asked to take a TAK- 438 tablet and a lansoprazole capsule twice daily in conjunction with bismuth-containing quadruple therapy for 2 weeks, followed up by a TAK-438 tablet and a lansoprazole capsule once daily for up to 4 weeks. HP negative (HP-) participants will be asked to take a TAK-438 tablet and a lansoprazole capsule once daily for up to 6 weeks.
This multi-center trial will be conducted China, Korea and Taiwan. The overall time to participate in this study is up to 10 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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 533 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 20 mg Compared to Lansoprazole 30 mg Once- or Twice-Daily in the Treatment of Endoscopically Confirmed Duodenal Ulcer Subjects With or Without Helicobacter Pylori Infection |
| Actual Study Start Date : | April 5, 2017 |
| Actual Primary Completion Date : | March 19, 2019 |
| Actual Study Completion Date : | July 19, 2019 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Experimental: TAK-438 20 mg
H. pylori negative (HP -) participants: TAK-438 20 mg, tablets, orally, once daily (QD) and lansoprazole placebo-matching capsules, orally, QD for up to 6 weeks. H. pylori positive (HP +) participants: TAK-438 20 mg, tablets, orally, twice daily (BID) and lansoprazole placebo-matching capsules, orally, BID for first 2 weeks along with Bismuth-Containing Quadruple Therapy followed byTAK-438 20 mg, tablets, orally, QD and lansoprazole placebo-matching capsules, orally, QD for up to 4 weeks.
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Drug: TAK-438
TAK-438 tablets
Other Name: Vonoprazan Drug: Lansoprazole Placebo Lansoprazole placebo-matching capsules Drug: Bismuth-Containing Quadruple Therapy 1 g Amoxicillin, 500 mg clarithromycin and 600 mg bismuth potassium citrate/bismuth tripotassium dicitrate, twice daily (BID). |
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Experimental: Lansoprazole 30 mg
H. pylori negative (HP -) participants: lansoprazole 30 mg, capsules, orally, QD and TAK-438 placebo-matching tablets, orally, QD for up to 6 weeks. HP + participants: lansoprazole 30 mg, capsules, orally, BID and TAK-438 placebo-matching tablets, orally, BID for first 2 weeks along with Bismuth-Containing Quadruple Therapy followed by lansoprazole 30 mg, capsules, orally, QD and TAK-438 placebo-matching tablets, orally, BID for up to 4 weeks.
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Drug: Lansoprazole
Lansoprazole capsules
Other Name: Prevacid Drug: TAK-438 Placebo TAK-438 placebo-matching tablets. Drug: Bismuth-Containing Quadruple Therapy 1 g Amoxicillin, 500 mg clarithromycin and 600 mg bismuth potassium citrate/bismuth tripotassium dicitrate, twice daily (BID). |
Primary Outcome Measures :
- Percentage of Participants With Endoscopically Confirmed Healing of Duodenal Ulcers [ Time Frame: Week 4 or Week 6 ]Endoscopic healing was defined as the disappearance of all white coats associated with duodenal ulcers as confirmed endoscopically.
Secondary Outcome Measures :
- Percentage of Helicobacter Pylori Infected (HP+) Participants With Successful HP Eradication After 4 or 6 Weeks of Treatment [ Time Frame: 4 weeks post treatment (Up to 10 weeks) ]HP infection status was 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.
- Percentage of Participants With Endoscopically Confirmed Healing of Duodenal Ulcer at Week 4 [ Time Frame: Week 4 ]Endoscopic healing is defined as the disappearance of all white coats associated with duodenal ulcers as confirmed endoscopically.
- Percentage of Participants With Posttreatment Resolution of Gastrointestinal Symptoms Associated With Duodenal Ulcer at Weeks 2 Through 6 [ Time Frame: Week 2 up to Week 6 ]The percentage of participants with resolution of various gastrointestinal symptoms are reported as categories. Gastrointestinal symptoms included epigastric pain (postprandial, fasting, nocturnal), abdominal bloating, nausea/vomiting, heartburn and lack of appetite. The severity of subjective symptoms of erosive esophagitis were recorded as: none = 0, mild = 1, moderate = 2 or severe = 3.
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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 duodenal ulcer(s) (i.e., mucosal defects with white coating [including cases associated with blood coagulation as long as there is no active bleeding]) measuring 5 mm or larger in longest diameter within 14 days prior to randomization.
Exclusion Criteria:
- Has received TAK-438 in a previous clinical study or as a therapeutic agent.
- 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.
- Has been treated with Helicobacter pylori eradication therapy within 30 days prior to study treatment.
- Has a diagnosis of duodenal malignancy or a duodenal ulcer whose morphology suggested malignancy as evident by endoscopy within 14 days prior to randomization.
- Is suspected of having acute gastro-duodenal mucosal lesions (AGDML) as evident by endoscopy within 14 days prior to randomization.
- Has a linear ulcer (including a linear ulcer scar) that has been confirmed as evident by endoscopy within 14 days prior to randomization.
- Has active postoperative (eg, endoscopic mucosal resection / endoscopic submucosal dissection) ulcer(s) as confirmed by endoscopy within 14 days prior to randomization.
- Has gastric ulcer that has been confirmed by endoscopy within 14 days prior to randomization.
- Has ulcers for which medical therapy alone is not indicated (eg, perforation, pyloric stenosis, duodenal stenosis, major bleeding).
- Has undergone therapeutic upper gastrointestinal (GI) endoscopic therapy (eg, endoscopic hemostasis or excision including biopsy) within 30 days prior to visit 1.
- Has Zollinger-Ellison syndrome or gastric acid hypersecretion or those with a history of gastric acid hypersecretion.
- 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 (eg, abdominal surgery, vagotomy or craniotomy).
- 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).
- Has a known acquired immunodeficiency syndrome (AIDS) 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).
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Laboratory tests performed prior to randomization revealed any of the following abnormalities in the participant:
- Creatinine levels: >2 mg/dL (>177 μmol/L).
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST), or total bilirubin levels: > upper limit of normal (ULN).
- 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): NCT03050359
Locations
Show 81 study locations
Sponsors and Collaborators
Takeda
Investigators
| Study Director: | Medical Director Clinical Science | Takeda |
Study Documents (Full-Text)
Documents provided by Takeda:
Documents provided by Takeda:
Study Protocol [PDF] August 30, 2018
Statistical Analysis Plan [PDF] July 23, 2019
| Responsible Party: | Takeda |
| ClinicalTrials.gov Identifier: | NCT03050359 |
| Other Study ID Numbers: |
TAK-438_304 U1111-1139-0293 ( Registry Identifier: WHO ) CTR20170104 ( Registry Identifier: CFDA ) |
| First Posted: | February 10, 2017 Key Record Dates |
| Results First Posted: | June 12, 2020 |
| Last Update Posted: | June 12, 2020 |
| Last Verified: | May 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment. |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Takeda:
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Drug therapy Gastrointestinal Diseases Digestive System Diseases Lansoprazole Anti-Ulcer Agents |
Gastrointestinal Agents Proton Pump Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
Additional relevant MeSH terms:
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Duodenal Ulcer Ulcer Pathologic Processes Peptic Ulcer Duodenal Diseases Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases Stomach Diseases |
Lansoprazole Dexlansoprazole Bismuth Anti-Ulcer Agents Gastrointestinal Agents Proton Pump Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antacids |