Gastric Ulcer Clinical Trial
Official title:
Nexium Capsules Specific Clinical Experience Investigation for Long-term Use Concerning Prevention of Recurrence of Gastric Ulcer or Duodenal Ulcer With NSAIDs
| NCT number | NCT01562600 |
| Other study ID # | D961HC00012 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | April 19, 2012 |
| Est. completion date | August 27, 2015 |
| Verified date | August 2019 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
The purpose of this investigation is to collect following data in patients given Nexium capsule (Nexium) for long term in usual-post-marketing therapy to prevention of recurrence of gastric ulcer or duodenal ulcer with non-steroidal anti-inflammatory drug (NSAID).
| Status | Completed |
| Enrollment | 1634 |
| Est. completion date | August 27, 2015 |
| Est. primary completion date | August 27, 2015 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility |
Inclusion Criteria: -Patients who are given NSAIDs for long terms to control pain due to disease such as rheumatoid arthritis and osteoarthritis, and given Nexium to suppress recurrence of gastric ulcer or duodenal ulcer. Exclusion Criteria: - Patients having gastric ulcer/duodenal ulcer when Nexium is started (Active phase (A1, A2) or healing phase (H1, H2) of Sakita-Miwa classification on endoscopy) - Patients who had been given Nexium for suppression of recurrence of gastric ulcer/duodenal ulcer. |
| Country | Name | City | State |
|---|---|---|---|
| Japan | Research Site | Aichi | |
| Japan | Research Site | Akita | |
| Japan | Research Site | Aomori | |
| Japan | Research Site | Chiba | |
| Japan | Research Site | Ehime | |
| Japan | Research Site | Fukui | |
| Japan | Research Site | Fukuoka | |
| Japan | Research Site | Fukushima | |
| Japan | Research Site | Gifu | |
| Japan | Research Site | Gunma | |
| Japan | Research Site | Hiroshima | |
| Japan | Research Site | Hokkaido | |
| Japan | Research Site | Hyogo | |
| Japan | Research Site | Ibaraki | |
| Japan | Research Site | Ishikawa | |
| Japan | Research Site | Iwate | |
| Japan | Research Site | Kagawa | |
| Japan | Research Site | Kagoshima | |
| Japan | Research Site | Kanagawa | |
| Japan | Research Site | Kochi | |
| Japan | Research Site | Kumamoto | |
| Japan | Research Site | Kyoto | |
| Japan | Research Site | Mie | |
| Japan | Research Site | Miyagi | |
| Japan | Research Site | Miyazaki | |
| Japan | Research Site | Nagano | |
| Japan | Research Site | Nagasaki | |
| Japan | Research Site | Nara | |
| Japan | Research Site | Niigata | |
| Japan | Research Site | Oita | |
| Japan | Research Site | Okayama | |
| Japan | Research Site | Osaka | |
| Japan | Research Site | Saga | |
| Japan | Research Site | Saitama | |
| Japan | Research Site | Shiga | |
| Japan | Research Site | Shimane | |
| Japan | Research Site | Shizuoka | |
| Japan | Research Site | Tochigi | |
| Japan | Research Site | Tokushima | |
| Japan | Research Site | Tokyo | |
| Japan | Research Site | Tottori | |
| Japan | Research Site | Toyama | |
| Japan | Research Site | Wakayama | |
| Japan | Research Site | Yamagata | |
| Japan | Research Site | Yamaguchi | |
| Japan | Research Site | Yamanashi |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
Japan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of Adverse Drug Reactions | Adverse event incidence | 1 Year | |
| Secondary | Non-recurrence rate of peptic ulcer | 1 Year |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05518929 -
Hypoxia During Gastroenterological Endoscope Procedures Sedated With Ciprofol In Overweight Or Obesity Patients
|
Phase 4 | |
| Completed |
NCT03291418 -
To Compare the Gastrointestinal Safety of a 14-Day Oral Dosing Regimen of ATB-346 to Sodium Naproxen in Healthy Subjects
|
Phase 1/Phase 2 | |
| Not yet recruiting |
NCT05526339 -
HFNO Combined With NPA Reduces Hypoxia During Sedated Gastrointestinal Endoscopy In Obese Patients
|
N/A | |
| Completed |
NCT01435525 -
Nexium Capsules Helicobacter Pylori Specific Clinical Experience Investigation
|
N/A | |
| Completed |
NCT00527787 -
Evaluating PN 400 (VIMOVO) in Reducing Gastric Ulcers Compared to Non-steroidal Antiinflammatory Drug (NSAID) Naproxen
|
Phase 3 | |
| Terminated |
NCT00594854 -
Evaluating PN 400 (VIMOVO) in Reducing Gastric Ulcers in High Risk Subjects Compared to Arthrotec
|
Phase 3 | |
| Completed |
NCT01129011 -
Evaluating PN 400 (VIMOVO) in Reducing Gastric Ulcers Compared to Non-steroidal Antiinflammatory Drug (NSAID) Naproxen
|
Phase 3 | |
| Recruiting |
NCT05517408 -
Dose Exploration of Ciprofol for Sedation in Gastrointestinal Endoscopic Diagnosis and Treatment of Obese Patients.
|
N/A | |
| Recruiting |
NCT01946633 -
Remote-controlled Capsule Endoscopy: a Feasibility Study
|
N/A | |
| Completed |
NCT01964131 -
BE Study Between a Capsule and a Sachet Formulation of D961H by Pharmacodynamics in Japanese Healthy Male Subjects
|
Phase 1 | |
| Completed |
NCT01150162 -
Mucosta in Gastric Ulcer Treatment, Effectiveness and Safety Evaluation
|
Phase 3 | |
| Recruiting |
NCT01037491 -
Comparison of Ulcer Healing in Patients Taking Rabeprazole With Different Antiplatelets
|
N/A | |
| Completed |
NCT00961350 -
A 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
|
Phase 3 | |
| Completed |
NCT00960869 -
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
|
Phase 3 | |
| Completed |
NCT00595517 -
Long Term Study to Investigate the Efficacy & Safety of D961H (Esomeprazole) for the Prevention of NSAIDs-induced Ulcer
|
Phase 3 | |
| Completed |
NCT00428701 -
An Open-label, Exploratory Trial to Assess Gastric Acid Control in Critically Ill Subjects Receiving Nexium
|
Phase 4 | |
| Completed |
NCT01452711 -
Efficacy of TAK-438 Compared to AG-1749 (Lansoprazole) in the Treatment of Gastric Ulcer
|
Phase 3 | |
| Terminated |
NCT05579444 -
Systems Biology of Gastrointestinal and Related Diseases
|
||
| Completed |
NCT02761512 -
Study to Evaluate the Safety and Efficacy of CJ-12420 in Patients With Gastric Ulcer
|
Phase 3 | |
| Recruiting |
NCT03057171 -
A Study on the Gastrointestinal Disease and Helicobacter Pylori Controlled Long Non-coding RNA
|