Clinical trials: Duodenal Ulcer
Gastric Ulcer (GU), Duodenal Ulcer (DU)
A Phase I/III Study of D961H 10 mg and 20 mg in Japanese Paediatric Patients With Gastrointestinal Acid Related Diseases
The objective of this study is to assess the safety, pharmacokinetics, pharmacodynamics and efficacy of repeated once daily oral administration of D961H 10 mg and D961H 20 mg in Japanese paediatric patients aged 1 to 14 years old…
- Conditions
- Gastric Ulcer (GU), Duodenal Ulcer (DU), Anastomotic Ulcer (AU), Non-erosive Reflux Esophagitis Disease (NERD)
- Trial name
- NCT02153398
- Testing
- D961H sachet 10 mg, D961H capsule 10mg, D961H capsule 20 mg
- Where
- 15 sites in Japan
- Volunteers
- 55 people
- Sponsor
- AstraZeneca
Gastric Ulcer
Study to Evaluate the Incidence of Gastric Ulcers Following Administration of Either PA32540 or Enteric Coated Aspirin 325 mg in Subjects Who Are at Risk for Developing Aspirin-Associated Ulcers
Primary: To demonstrate that PA32540 causes fewer gastric ulcers in subjects at risk for developing aspirin-associated gastric ulcers compared to enteric coated (EC) aspirin 325 mg.
- Trial name
- NCT00960869
- Testing
- PA32540, EC-Aspirin 325 mg
- Where
- United States
- Volunteers
- 519 people
- Sponsor
- POZEN
Gastric Ulcer, Duodenal Ulcer
Study of Esomeprazole 20 mg or 40 mg vs Placebo Effectiveness on the Occurrence of Peptic Ulcers in Subjects on Low Dose Acetylsalicylic Acid (LDA)
The purpose of this study is to compare the effect of esomeprazole 20 or 40 mg once daily versus placebo on the occurrence of peptic ulcers during 26 weeks in subjects on continuous low-dose acetylsalicylic acid.
- Trial name
- Oberon (NCT00441727)
- Testing
- Esomeprazole 40 mg, Esomeprazole 20 mg
- Where
- 189 sites in United States, Argentina and 18 more
- Volunteers
- 2,426 people
- Sponsor
- AstraZeneca
Gastric Ulcer
Comparison of TAK-438 (Vonoprazan) to Lansoprazole in the Treatment of Gastric Ulcer Participants With or Without Helicobacter Pylori Infection
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.
- Trial name
- NCT03050307
- Testing
- TAK-438, Lansoprazole, Bismuth-Containing Quadruple Therapy
- Where
- 81 sites in China, Philippines and 2 more
- Volunteers
- 234 people
- Sponsor
- Takeda
Gastric or Duodenal Ulcers
Long-term Use of Takepron Capsules on the Prevention of Recurrence of Gastric/Duodenal Ulcer in Patients Receiving Low-dose Aspirin
The purpose of this study is to investigate the safety and efficacy of long-term administration of lansoprazole (Takepron) for up to 12 months in the routine clinical setting in patients receiving low-dose aspirin
- Trial name
- NCT02099682
- Testing
- Lansoprazole
- Volunteers
- 3,366 people
- Sponsor
- Takeda
Duodenal Ulcer
Comparison of TAK-438 (Vonoprazan) to Lansoprazole in the Treatment of Duodenal Ulcer Participants With or Without Helicobacter Pylori Infection
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.
- Trial name
- NCT03050359
- Testing
- TAK-438, Lansoprazole, Bismuth-Containing Quadruple Therapy
- Where
- 81 sites in China, Philippines and 2 more
- Volunteers
- 533 people
- Sponsor
- Takeda
Prevention
Comparative Efficacy & Safety Study of D961H Versus Placebo for the Prevention of Gastric and Duodenal Ulcers With Low-dose Aspirin
To assess the efficacy of D961H 20 mg once daily (q.d.) versus placebo in continuous treatment involving patients with a history of gastric and/or duodenal ulcers receiving daily Low-dose aspirin therapy by evaluating time from…
- Trial name
- NCT01069939
- Testing
- Esomeprazole
- Where
- 46 sites in Japan, South Korea and 1 more
- Volunteers
- 427 people
- Sponsor
- AstraZeneca
Gastric Ulcers Duodenal Ulcers Caused by Low-dose Aspirin
Long-term Prevention of Recurrent Gastric or Duodenal Ulcers Caused by Low-dose Aspirin With Rabeprazole (E3810) Treatment (Planetarium Study)
The primary objective of this study to examine the long-term safety of rabeprazole 5 mg or 10 mg tablets administered once daily in participants who were confirmed to have no recurrence of gastric or duodenal ulcer by endoscopic…
- Trial name
- NCT01398410
- Testing
- Rabeprazole
- Where
- 50 sites in Japan
- Volunteers
- 405 people
- Sponsor
- Eisai Co., Ltd.
Refractory Reflux Esophagitis
Double-blind Comparative Study of E3810 Tablets (10 or 20 mg b.i.d.) to Evaluate Efficacy and Safety in Patients With Refractory Reflux Esophagitis
The purpose of this study is to evaluate the efficacy and safety of E3810 tablets in patients with Proton Pump Inhibitor-resistant reflux esophagitis.
- Trial name
- NCT00770913
- Testing
- E3810
- Where
- 54 sites in Japan
- Volunteers
- 337 people
- Sponsor
- Eisai Co., Ltd.
Gastric Ulcer, Duodenal Ulcer, Acute Stress Gastritis, and Acute Gastric Mucosal Lesions
Lansoprazole Intravenous 30 mg Specified Drug-use Survey [Hemostatic Effect/Rebleeding Rate]
The purpose of this survey is to evaluate the safety (i.e., frequency of adverse events) and efficacy (i.e., hemostatic effect, rate of rebleeding after confirmation of hemostasis) of administration of lansoprazole intravenous 30…
- Trial name
- NCT02151786
- Testing
- Lansoprazole
- Volunteers
- 1,120 people
- Sponsor
- Takeda
Peptic Ulcer
Efficacy and Safety Study of HZT-501 in Reducing the Risk of Ibuprofen-associated Ulcers
The purpose of this study is to evaluate whether HZT-501 is effective in reducing the rate of development of ibuprofen-associated ulcers in patients who require long-term daily use of ibuprofen.
- Trial name
- NCT00450658
- Testing
- HZT-501, Ibuprofen
- Volunteers
- 627 people
- Sponsor
- Amgen
Gastric/Duodenal Ulcer, Gastric MALT Lymphoma, Idiopathic Thrombocytopenic Purpura, or H. Pylori Gastritis, and Other
Drug Use Surveillance of Takecab for "Supplement to Helicobacter Pylori Eradication"
The purpose of this study is to evaluate the safety and efficacy on participants receiving first-line eradication and second-line eradication including vonoprazan (Takecab) tablets (triple therapy) in the routine clinical setting.
- Trial name
- NCT03219723
- Testing
- Vonoprazan, Amoxicillin hydrate, Clarithromycin
- Where
- Japan
- Volunteers
- 560 people
- Sponsor
- Takeda
Gastric Ulcer
Evaluating PN 400 (VIMOVO) in Reducing Gastric Ulcers in High Risk Subjects Compared to Arthrotec
This randomized, double-blind, parallel-group, controlled, multi-center clinical trial of 6 months duration is designed to assess the efficacy, tolerability and safety of PN400 versus diclofenac/misoprostol in subjects at high…
- Trial name
- NCT00594854
- Testing
- PN400 (VIMOVO), Diclofenac/Misoprostol
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- POZEN
Gastric or Duodenal Ulcers
Long-term Use of Takepron on the Prevention of Recurrence of Gastric/Duodenal Ulcer in Patients Receiving Non-steroidal Anti-inflammatory Drugs
The purpose of this study is to investigate the safety and efficacy of long-term administration of lansoprazole (Takepron) therapy for up to 12 months in the routine clinical setting in patients receiving oral non-steroidal…
- Trial name
- NCT02099708
- Testing
- Lansoprazole
- Volunteers
- 3,502 people
- Sponsor
- Takeda
Reflux Esophagitis
Vonoprazan Study of Investigating the Effect on Sleep Disturbance Associated With Reflux Esophagitis- Exploratory Evaluation
The purpose of this study is to exploratorily evaluate the effect of vonoprazan 20 mg on sleep disturbance of patients with reflux esophagitis, who have heartburn and/or regurgitation and ≥ 6.0 in the Pittsburgh Sleep Quality…
- Trial name
- VISTAEXE (NCT03116841)
- Testing
- Vonoprazan
- Where
- 6 sites in Japan
- Volunteers
- 3 people
- Sponsor
- Takeda
Reflux Esophagitis, Gastric Ulcer
A Study of Esomeplazole (D961H) in Japanese Paediatric Patients With Reflux Esophagitis, Gastric Ulcer or Duodenal Ulcer
This is an open label, parallel group, multi-centre, phase III study to assess the safety and efficacy of D961H in maintenance therapy following initial healing therapy in Japanese paediatric patients with reflux esophagitis, and…
- Conditions
- Reflux Esophagitis, Gastric Ulcer, Duodenal Ulcer
- Trial name
- NCT03553563
- Testing
- D961H capsule 10mg, D961H sachet 10mg
- Where
- 15 sites in Japan
- Volunteers
- 50 people
- Sponsor
- AstraZeneca
Refractory Reflux Esophagitis
Compare D961H 20 mg Bid and 20 mg qd in Patients With Refractory Reflux Esophagitis (Inflammation of Lower Esophagus)
This is a phase 3 multicentre, randomised, double-blind, parallel-group, comparative study to evaluate the efficacy of esomeprazole (D961H) 20 mg twice daily and esomeprazole (D961H) 20 mg once daily in patients (in the form of…
- Trial name
- NCT01669811
- Testing
- Esomeprazole (D961H) twice daily, Esomeprazole (D961H) once daily
- Where
- 63 sites in Japan
- Volunteers
- 1,398 people
- Sponsor
- AstraZeneca
Esophagitis, Reflux, Esophagitis, Peptic
Comparison of Dexlansoprazole MR to Placebo on the Ability to Maintain Healing in Subjects With Healed Erosive Esophagitis
The purpose of this study is to assess the ability of once-daily (QD) treatment with Dexlansoprazole modified-release (MR) 60 mg and 90 mg and placebo in maintaining healing of erosive esophagitis (EE).
- Trial name
- NCT00255151
- Testing
- Dexlansoprazole MR
- Where
- 100 sites in United States
- Volunteers
- 451 people
- Sponsor
- Takeda
Gastric Ulcer
Efficacy and Safety Study of Esomeprazole 20mg qd vs Ranitidine 150mg Bid in Patients With an NSAID-induced Gastric Ulcer
The purpose of this study is to assess the efficacy of esomeprazole 20 mg dosed once daily and ranitidine 150 mg dosed twice daily through 4 weeks of treatment for the healing of gastric ulcers in patients receiving daily…
- Trial name
- NCT00401752
- Testing
- Esomeprazole, Ranitidine
- Where
- 9 sites in China, Hong Kong
- Volunteers
- 397 people
- Sponsor
- AstraZeneca
Reflux Esophagitis
Reflux Esophagitis Phase III Study (Maintenance Treatment)
The primary objective of this study is to evaluate the efficacy of esomeprazole 20 mg once daily for 24 weeks on maintenance of Reflux Esophagitis in patients with healed reflux esophagitis in comparison with omeprazole 10 mg…
- Trial name
- NCT00634114
- Testing
- Esomeprazole, Omeprazole
- Where
- 44 sites in Japan
- Volunteers
- 540 people
- Sponsor
- AstraZeneca