CClinicalTrials.gg
Sign In
CompletedNCT02166008Updated Feb 27, 2019

Cytoprotective Agent and Peptic Ulcer in Dual Antiplatelet :RCT

A Phase 2/3 interventional study of Repamipide and Placebo in Gastric Ulcer Induced by Anti-platelet Agent and Duodenal Ulcer Induced by Anti-platelet Agent, sponsored by King Chulalongkorn Memorial Hospital. Completed at 1 site in Thailand. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-02-27.

Sponsored by King Chulalongkorn Memorial Hospital · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
142
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

  • 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
02

Conditions studied

  • Gastric Ulcer Induced by Anti-platelet Agent
  • Duodenal Ulcer Induced by Anti-platelet Agent

Keywords

  • Repamipide
  • Dual antiplatelet
  • Peptic ulcer
03

In context

Peptic Ulcer

193 studies on the registry are indexed under Peptic Ulcer; 31 are open to participants now.

This study's enrollment of 142 is close to the median of 150 across 142 interventional studies indexed under Peptic Ulcer.

Browse Peptic Ulcer studies →

Lead sponsor

King Chulalongkorn Memorial Hospital is the lead sponsor of 42 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Age 18-70 year-old
  2. Had cardiovascular disease which needed clopidogrel and aspirin
  3. Stable enough for gastroscopy

Exclusion criteria

Exclusion Criteria:

  1. Gastroscopy revealed peptic ulcer
  2. Had contraindication for gastroscopy
  3. Not allowed for gastroscopy by cardiologist
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
142 participants (actual)

Study arms

  • Active comparator
    Repamipide

    Rebamipide (100) 1 tab oral tid for 1 year or peptic ulcer occurred

    Drug: Repamipide

  • Placebo comparator
    placebo

    A placebo is a simulated or otherwise medically ineffectual treatment for a disease or other medical condition intended to deceive the recipient. It will be prescribed as the same regimen of Rabamipide.

    Drug: Placebo

Interventions

  • DrugRepamipide
  • DrugPlacebo

    Also known as: Placebo will be made in the same configuration of rabamipide

06

What researchers measure

Primary outcomes

  1. number of peptic ulcer by end0scopy

    Time frame: 1 year

07

Study locations

1 site
  • King Chulalongkorn Memorial Hospital
    Patumwan, Bangkok 10330, Thailand
08

References and documents

Publications

  • Pittayanon R, Piyachaturawat P, Rerknimitr R, Prueksapanich P, Chaitongrat S, Lertsuwunseri V, Srimahachota S, Mahachai V. Cytoprotective agent for peptic ulcer prevention in patients taking dual antiplatelet agents: A randomized, double-blind placebo-controlled trial. J Gastroenterol Hepatol. 2019 Sep;34(9):1517-1522. doi: 10.1111/jgh.14671. Epub 2019 May 8. PubMed 30919492 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 27, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02166008
Lead sponsor
King Chulalongkorn Memorial Hospital
Responsible party
Rapat Pittayanon, MD (Doctor, King Chulalongkorn Memorial Hospital) — Principal investigator
First posted
Jun 18, 2014
Start date
Jul 2014
Primary completion
Jun 2017
Completion
Jun 2018
Last update
Feb 27, 2019

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Peptic Ulcer→

Other studies from this sponsor

King Chulalongkorn Memorial Hospital

Start the discussion