Clinical Trial: Efficacy and Safety of PMK-S005 in the Prevention of Recurrent Peptic Ulcer in Low-dose Aspirin Users

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Multiple-center, Randomized, Double-blind, Parallel, Placebo-controlled, Dose-selection Phase II Study to Evaluate the Efficacy and Safety of PMK-S005 in the Prevention of Recurrent Same as current

Current Secondary Outcome:

  • The incidence of endoscopic stomach / duodenal mucosal disease(erosion, ulcer) [ Time Frame: 12 weeks ]
  • The incidence of endoscopic stomach / duodenal erosion [ Time Frame: 12 weeks ]
  • The incidence of endoscopic stomach / duodenal ulcer [ Time Frame: 12 weeks ]
  • The changes of MLS in the gastroduodenal endoscopy result compared to baseline [ Time Frame: 12 weeks ]
  • The incidence of endoscopic esophagitis [ Time Frame: 16 weeks ]
  • Rescue drug use count and the total amount [ Time Frame: 16 weeks ]
  • Changes in gastrointestinal symptoms score [ Time Frame: 16 weeks ]


Original Secondary Outcome: Same as current

Information By: PharmaKing

Dates:
Date Received: December 19, 2014
Date Started: September 2014
Date Completion: December 2016
Last Updated: March 29, 2016
Last Verified: March 2016