Gastric Ulcer Clinical Trial
Official title:
A 12-month, Phase 3, Open-label, Multi-center Study to Evaluate the Long-term Safety of PN400 in Subjects Who Are at Risk for Developing NSAID-associated Ulcers
This study uses an open-label design and will be conducted in approximately 60 sites aiming to enroll a total number of 200 subjects to ensure that at least 100 subjects will have 12 months exposure to PN400 (VIMOVO).
PN400 is proposed for the treatment of the signs and symptoms of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis or other medical conditions expected to require daily NSAID therapy for at least 12 months in patients at risk for developing NSAID-associated gastric ulcers. This study is designed to provide long-term safety data for PN400 in order to gain regulatory approval to make PN400 available for clinical use in this subject population. ;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| 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 |
NCT01129011 -
Evaluating PN 400 (VIMOVO) in Reducing Gastric Ulcers Compared to Non-steroidal Antiinflammatory Drug (NSAID) Naproxen
|
Phase 3 | |
| 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 | |
| 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 |
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 |
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 |
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
|