36 completed, 1 recruiting. 20 Phase 3, 10 Phase 1, 2 Phase 2.
By phase and status
Follow TAK-438: new trials by email Literature Review of TAK-438 trials Research Report on TAK-438
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|
Evaluating the Efficacy of Vonoprazan in Preventing Post-Endoscopic Variceal Band Ligation Ulcers: A Randomized Controlled Trial
Vonoprazan 20 mg, Placebo - Cirrhoses, Liver | Phase 2 | Recruiting | King Edward Medical University | 154 | 2025-12-16 | 2025-12-26 |
A Study of Vonoprazan in Adults With Helicobacter Pylori
Clarithromycin, Amoxicillin, Bismuth potassium citrate - Helicobacter Pylori | Phase 1 | Completed | Takeda | 44 | 2021-04-06 | 2023-08-31 |
A Study to Evaluate the Efficacy and Safety of Bismuth-Containing Quadruple Therapy With Oral Vonoprazan (TAK-438) 20 mg Compared to Esomeprazole 20 mg Twice Daily in Paticipants With Helicobacter Pylori Infection
Vonoprazan, Amoxicillin, Clarithromycin - Helicobacter Pylori | Phase 3 | Completed | Takeda | 510 | 2020-04-30 | 2023-09-07 |
A Bioequivalence (BE) Study of TAK-438 Orally Disintegrating (OD) Tablet
TAK-438 OD, TAK-438 - Japanese Healthy Adult Male | Phase 1 | Completed | Takeda | 48 | 2019-01-30 | 2020-04-07 |
A Study to Evaluate the Bioequivalence (BE) and the Food Effect of TAK-438ASA Tablet
TAK-438ASA, TAK-438, Aspirin - Healthy Volunteers | Phase 1 | Completed | Takeda | 276 | 2018-03-08 | 2019-11-19 |
A Pharmacokinetic Study of TAK-438 in Healthy Adult Chinese Participants
TAK-438 - Healthy Participants | Phase 1 | Completed | Takeda | 33 | 2017-04-19 | 2019-01-30 |
Comparison of TAK-438 (Vonoprazan) to Lansoprazole in the Treatment of Gastric Ulcer Participants With or Without Helicobacter Pylori Infection
TAK-438, Lansoprazole, TAK-438 Placebo - Gastric Ulcer | Phase 3 | Completed | Takeda | 234 | 2017-04-17 | 2021-06-18 |
Comparison of TAK-438 (Vonoprazan) to Lansoprazole in the Treatment of Duodenal Ulcer Participants With or Without Helicobacter Pylori Infection
TAK-438, Lansoprazole, TAK-438 Placebo - Duodenal Ulcer | Phase 3 | Completed | Takeda | 533 | 2017-04-05 | 2020-06-12 |
TAK-438 Bismuth Drug Interaction Study
Clarithromycin, Amoxicillin, Tripotassium bismuth dicitrate - Helicobacter Pylori | Phase 1 | Completed | Takeda | 30 | 2016-09-05 | 2019-01-03 |
Special Drug Use Surveillance of Vonoprazan for "Prevention of Recurrence of Gastric/Duodenal Ulcer in Patients Receiving Non-steroidal Anti-inflammatory Drugs: Long-term Use"
Vonoprazan - A History of Gastric or Duodenal Ulcers | | Completed | Takeda | 1304 | 2016-09-01 | 2023-06-07 |
Special Drug Use Surveillance of Vonoprazan for "Prevention of Recurrence of Gastric/Duodenal Ulcer in Patients Receiving Low-dose Aspirin: Long-term Use"
Vonoprazan - Gastric or Duodenal Ulcers | | Completed | Takeda | 1119 | 2016-09-01 | 2020-03-11 |
Comparison of Vonoprazan to Esomeprazole in Participants With Symptomatic GERD Who Responded Partially to a High Dose of Proton Pump Inhibitor (PPI)
Vonoprazan, Esomeprazole, Esomeprazole Placebo - Gastroesophageal Reflux | Phase 2 | Completed | Takeda | 256 | 2016-07-14 | 2020-02-18 |
Drug Use Surveillance of Vonoprazan for "Gastric Ulcer, Duodenal Ulcer, and Reflux Esophagitis"
Vonoprazan - Gastric Ulcer, Duodenal Ulcer, and Reflux Esophagitis | | Completed | Takeda | 3183 | 2016-03-01 | 2019-12-12 |
Special Drug Use Surveillance of Vonoprazan for "Maintenance Therapy of Reflux Esophagitis: Long-term Use"
Vonoprazan - Reflux Esophagitis | | Completed | Takeda | 1237 | 2016-03-01 | 2025-06-10 |
Drug Use Surveillance of Takecab for "Supplement to Helicobacter Pylori Eradication"
Vonoprazan, Amoxicillin hydrate, Clarithromycin - Gastric/Duodenal Ulcer, Gastric MALT Lymphoma, Idiopathic Thrombocytopenic Purpura, or H. Pylori Gastritis, and Other | | Completed | Takeda | 560 | 2015-09-01 | 2019-03-22 |
Efficacy and Safety of Vonoprazan Compared to Lansoprazole in the Maintenance Treatment of Erosive Esophagitis
Vonoprazan, Lansoprazole, Vonoprazan Placebo - Erosive Esophagitis | Phase 3 | Completed | Takeda | 703 | 2015-04-01 | 2020-02-21 |
Efficacy and Safety of Oral Once-Daily Vonoprazan (TAK-438) in Participants With Erosive Esophagitis
Vonoprazan, Lansoprazole, Vonoprazan Placebo - Erosive Esophagitis | Phase 3 | Completed | Takeda | 481 | 2015-03-24 | 2019-06-03 |
Phase 3 Study to Evaluate the Acid-Inhibitory Effect of Multiple Oral Doses of Vonoprazan (TAK-438)
Vonoprazan, Esomeprazole, Rabeprazole sodium - Healthy Volunteers | Phase 3 | Completed | Takeda | 20 | 2014-01-01 | 2016-10-17 |
A Randomized, Double-Blind, Multicenter Study to Evaluate the Acid-inhibitory and Dose-response Efficacy of TAK-438 (20 mg, 40 mg) in Patients With Proton Pump Inhibitor (PPI) - Resistant Erosive Esophagitis
TAK-438 - Erosive Esophagitis | Phase 3 | Completed | Takeda | 19 | 2012-07-01 | 2014-02-10 |
A Unblinded Study of TAK-438 (20 mg) for Prevention of Recurrence of Gastric or Duodenal Ulcer During Long-Term Low-Dose Aspirin Therapy
TAK-438 - Gastric Ulcer, Duodenal Ulcer | Phase 3 | Completed | Takeda | 27 | 2012-05-01 | 2014-02-10 |
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Conditions studied
Duodenal Ulcer (12) · Stomach Ulcer (9) · Esophagitis, Peptic (2) · Gastroesophageal Reflux (2) · Digestive System Diseases (1) · Esophageal and Gastric Varices (1) · Fibrosis (1) · Gastrointestinal Diseases (1) · Hypertension, Portal (1) · Purpura, Thrombocytopenic, Idiopathic (1)
Sponsors
Takeda (36) · King Edward Medical University (1)
Countries
Japan (22) · China (7) · South Korea (5) · Taiwan (4) · Malaysia (2) · Philippines (2) · United Kingdom (2) · Belgium (1) · Bulgaria (1) · Czechia (1) · Estonia (1) · Pakistan (1) · Poland (1)
Top investigators
Steve Warrington (1)
Results publications
PMID 25707624, PMID 27891632, PMID 28988197, PMID 29196436, PMID 39085080, PMID 26935876, PMID 27928738, PMID 28119763, PMID 31409606, PMID 36264125, PMID 38654422, PMID 39965795, PMID 41982134
NIH funding
2008 (1), 2015 (1)