14 completed, 2 withdrawn, 1 unknown. 17 Phase 1, 1 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 17 | Completed 14, Withdrawn 2, Unknown 1 |
| Phase 2 | 1 | Withdrawn 1 |
Follow Dexlansoprazole: new trials by email Literature Review of Dexlansoprazole trials Research Report on Dexlansoprazole
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 |
|---|---|---|---|---|---|---|
| Phase 1 Dexlansoprazole Delayed-Release Capsules for Acid-Related Disorders in Infants Aged 1 to 11 Months Dexlansoprazole - Pediatric Gastroesophageal Reflux Disease | Phase 1 | Withdrawn | Takeda | 2025-06-15 | 2020-04-15 | |
| Bioequivalence Study of DelanzoᵀᴹDR 60mg (Dexlansoprazole) Capsule With Dexilant® 60mg (Dexlansoprazole) Capsule in Healthy Pakistani Subjects. Dexlansoprazole - Healthy, Bioequivalence Study | Phase 1 | Completed | University of Karachi | 60 | 2021-09-18 | 2023-11-29 |
| A Study to Compare the Bioavailability (BA) of Dexlansoprazole Delayed-release Capsules 30 mg dexlansoprazole capsules manufactured at TOB, 30 mg dexlansoprazole capsules manufactured at TPC, 60 mg dexlansoprazole capsules manufactured at TOB - Healthy Volunteers | Phase 1 | Completed | Takeda | 122 | 2019-01-10 | 2020-03-19 |
| A Study to Evaluate the Pharmacokinetics of Dexlansoprazole 30 Milligram (mg) and 60 mg Delayed-release Capsules in Healthy Chinese Participants Dexlansoprazole - Healthy Volunteers | Phase 1 | Completed | Takeda | 40 | 2017-11-22 | 2019-05-10 |
| A Clinical Trial to Evaluate the Safety and Tolerability of Dexlansoprazole Injection in Healthy Chinese Adults（Part 2） Dexlansoprazole Injection, Lansoprazole Injection - Effect of Drugs, Safety Issues | Phase 1 | Unknown | First Affiliated Hospital of Zhejiang University | 70 | 2017-05-05 | 2017-04-19 |
| Bioequivalence Study of Dexlansoprazole Capsules From Two Manufacturing Plants 30 mg dexlansoprazole capsules manufactured at TOB, 30 mg dexlansoprazole capsules manufactured at TPC, 60 mg dexlansoprazole capsules manufactured at TOB - Healthy Volunteers | Phase 1 | Completed | Takeda | 116 | 2017-04-25 | 2019-06-14 |
| A Clinical Trial to Evaluate the Safety and Tolerability of Dexlansoprazole Injection in Healthy Chinese Adults (Part 1) dexlansoprazole injection, placebo - Safety Issues | Phase 1 | Completed | First Affiliated Hospital of Zhejiang University | 28 | 2017-01-01 | 2017-03-16 |
| Pharmacodynamic Properties of CJ-12420 on Evening Dosing Dexlansoprazole 60 MG, CJ-12420 50mg, CJ-12420 100mg - Healthy | Phase 1 | Completed | HK inno.N Corporation | 24 | 2015-05-13 | 2017-02-06 |
| Sensory Evaluation of Dexlansoprazole Delayed-Release Orally Disintegrating Tablets Dexlansoprazole - Gastroesophageal Reflux Disease, Erosive Esophagitis | Phase 1 | Completed | Takeda | 8 | 2014-02-01 | 2015-03-06 |
| Bioavailability, Safety, and Pharmacodynamics of Dexlansoprazole Delayed-Release Orally Disintegrating Tablets in Healthy Participants Dexlansoprazole Delayed Release Orally Disintegrating Tablets, Dexlansoprazole Delayed Release Capsules - Bioavailability | Phase 1 | Completed | Takeda | 52 | 2014-02-01 | 2015-04-14 |
| A Bioequivalence Study of Dexlansoprazole From Doxirazole 60 mg Capsules (Hikma Pharma,Egypt)and Dexilant 60 mg Delayed Release (DR) Capsules (Takeda Pharmaceuticals America Inc., USA) Doxirazole, Dexilant - Healthy | Phase 1 | Completed | Genuine Research Center, Egypt | 60 | 2013-02-01 | 2015-08-20 |
| Predictors of Proton Pump Inhibitor (PPI) Response in Eosinophilic Esophagitis dexlansoprazole - Gastroesophageal Reflux Disease, Eosinophilic Esophagitis | Phase 1 / Phase 2 | Withdrawn | Mayo Clinic | 2012-03-01 | 2012-04-19 | |
| Effect of Dexlansoprazole on Bone Homeostasis Dexlansoprazole, Esomeprazole, Placebo - Homeostasis, Bone and Bones | Phase 1 | Completed | Takeda | 115 | 2010-11-01 | 2024-03-18 |
| Can E-cadherin Found in Tissue/Blood be Valuable in Identifying & Monitoring Patients With Post-proton Pump Inhibitor (PPI)-Responsive Heartburn Dexlansoprazole - Heartburn, Gastroesophageal Reflux Disease | Phase 1 | Completed | University of North Carolina, Chapel Hill | 40 | 2010-06-01 | 2016-12-19 |
| Study to Evaluate the Pharmacokinetics and Safety of Dexlansoprazole in Pediatric Subjects With Symptomatic Gastroesophageal Reflux Disease Dexlansoprazole - Gastroesophageal Reflux | Phase 1 | Completed | Takeda | 36 | 2010-03-01 | 2012-04-05 |
| A Study of the Effects of Multiple Doses of Dexlansoprazole, Lansoprazole, Omeprazole or Esomeprazole on the Pharmacokinetics and Pharmacodynamics of Clopidogrel in Healthy Participants. Clopidogrel, Clopidogrel and Lansoprazole, Clopidogrel and Dexlansoprazole - Healthy | Phase 1 | Completed | Takeda | 160 | 2009-12-01 | 2012-02-03 |
| Pharmacokinetic and Safety of Dexlansoprazole in Adolescents With Gastroesophageal Reflux Disease Dexlansoprazole MR - Gastroesophageal Reflux | Phase 1 | Completed | Takeda | 36 | 2009-05-01 | 2012-02-02 |
Gastroesophageal Reflux (5) · Heartburn (3) · Deglutition Disorders (1) · Eosinophilic Esophagitis (1) · Esophagitis, Peptic (1) · Laryngopharyngeal Reflux (1) · Stomach Ulcer (1) · Zollinger-Ellison Syndrome (1)
Takeda (10) · First Affiliated Hospital of Zhejiang University (2) · Genuine Research Center, Egypt (1) · HK inno.N Corporation (1) · Mayo Clinic (1) · University of Karachi (1) · University of North Carolina, Chapel Hill (1)
United States (10) · China (2) · Egypt (1) · Israel (1) · Italy (1) · Mexico (1) · Pakistan (1) · Poland (1) · South Korea (1)
Lihua Wu, Doctor (2) · Ahmed Elshafeey, Ph.D. Pharma (1) · Eunji Kim (1) · Jeffrey A Alexander, MD (1) · Prof. Dr. Muhammad R Shah, PhD (1) · Roy C Orlando, MD (1)
PMID 21716130, PMID 22464259, PMID 23333143, PMID 30445008, PMID 31338800
2014 (1)