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NCT02166008

Cytoprotective Agent for Peptic Ulcer Prevention in Patients Taking Dual Antiplatelet Agents: A Randomized Double-blind Placebo Control Trial Study

Completed Phase 2/Phase 3 Last updated 26 February 2019
What this trial tests

Phase 2/Phase 3 trial testing Repamipide in Gastric Ulcer Induced by Anti-platelet Agent in 142 participants. Completed in 1 June 2018.

Timeline
1 July 2014
Primary endpoint
1 June 2017
1 June 2018

Quick facts

Lead sponsorKing Chulalongkorn Memorial Hospital
PhasePhase 2/Phase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment142
Start date1 July 2014
Primary completion1 June 2017
Estimated completion1 June 2018
Sites1 location across Thailand

Drugs / interventions tested

Conditions studied

Sponsor

King Chulalongkorn Memorial Hospital

Who can join

Adults 18 to 70, any sex, with Gastric Ulcer Induced by Anti-platelet Agent or Duodenal Ulcer Induced by Anti-platelet Agent. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sponsor's own description

* Primary objective : To evaluate the efficacy of Rapamide in peptic ulcer prevention in patients taking dual antiplatelet agents * Study Design: Single center, double-blind, randomized-control trial study * Study drug: Repamipide vs. placebo * Assessment criteria The patients will be discharged from the study when one of the followings occurred, 1. Peptic ulcer from upper endoscopy at 3 and 6 month follow up 2. Clinical of upper gastrointestinal bleeding with peptic ulcer from upper endoscopy 3. Anemia by CBC at 1,3 ,6,12 month with peptic ulcer from upper endoscopy 4. Evidence of recurrent myocardial infarction from stent thrombosis

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Cytoprotective agent for peptic ulcer prevention in patients taking dual antiplatelet agents: A randomized, double-blind placebo-controlled trial.
    Pittayanon R, Piyachaturawat P, Rerknimitr R, Prueksapanich P, et al · · 2019 · cited 1× · PMID 30919492 · DOI 10.1111/jgh.14671

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