Clinical Trials Logo
  1. Home
  2. Gastric Ulcer
  3. NCT03291418

To Compare the Gastrointestinal Safety of a 14-Day Oral Dosing Regimen of ATB-346 to Sodium Naproxen in Healthy Subjects

Gastric Ulcer Clinical Trial

Official title:
A Double-Blind, Controlled Study to Compare the Gastrointestinal Safety of a 14-Day Oral Dosing Regimen of ATB-346 to Sodium Naproxen in Healthy Subjects

Clinical Trial Summary

A Double-Blind, Controlled Study to Compare the Gastrointestinal Safety of a 14-Day Oral Dosing Regimen of ATB-346 to Sodium Naproxen in Healthy Subjects

Clinical Trial Description

Healthy male and female subjects (n=240) are randomized into two dose groups of 120 subjects each. Gastroduodenal endoscopies are performed pre-dose and post-dose, i.e., after 14 days of either ATB-346 (250 mg once daily) or naproxen sodium (550 mg twice daily) and the incidence of gastric mucosal damage is recorded for comparison between the two treatment arms. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03291418
Study type Interventional
Source Antibe Therapeutics Inc.
Contact
Status Completed
Phase Phase 1/Phase 2
Start date September 8, 2017
Completion date April 30, 2018
View Details
See also
  Status Clinical Trial Phase
Completed NCT05518929 - Hypoxia During Gastroenterological Endoscope Procedures Sedated With Ciprofol In Overweight Or Obesity Patients Phase 4
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 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
Completed NCT01568398 - A Unblinded Study of TAK-438 (20 mg) for Prevention of Recurrence of Gastric or Duodenal Ulcer During Long-Term Low-Dose Aspirin Therapy Phase 3