Clinical Trials Logo
  1. Home
  2. Peptic Ulcer
  3. NCT01138969
  4. Details
NCT01138969 Clinical Trial

Efficacy of Proton Pump Inhibitor in Prevention of Clopidogrel-related Peptic Ulcer

Peptic Ulcer Clinical Trial

Official title:
Efficacy of Proton Pump Inhibitor in Prevention of Clopidogrel-related Peptic Ulcer and Gastrointestinal Bleeding

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01138969
Other study ID # VGHKS98-CT6-12
Secondary ID
Status Completed
Phase Phase 2
First received June 7, 2010
Last updated September 6, 2015
Start date August 2008
Est. completion date December 2012

Study information
Verified date September 2015
Source Kaohsiung Veterans General Hospital.
Contact n/a
Is FDA regulated No
Health authority Taiwan: Institutional Review Board
Study type Interventional

Clinical Trial Summary

Proton Pump Inhibitors (PPI) can prevent the recurrence of peptic ulcer in clopidogrel users.

Description:

The aim of the prospective, randomized study is to investigate the efficacy of PPI in prevention of ulcer recurrence for clopidogrel users. We plan to enroll 300 clopidogrel users without baseline gastroduodenal ulcer at initial endoscopy. The patients will be randomly assigned to receive either (1) esomeprazole (20 mg qd) plus clopidogrel or (2) clopidogrel treatment alone for 6 months. The ulcer recurrence rate between the treatment groups will be compared.

Recruitment information / eligibility
Status Completed
Enrollment 165
Est. completion date December 2012
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- We plan to enroll 300 clopidogrel users without baseline gastroduodenal ulcer at initial endoscopy. The patients will be randomly assigned to receive either (1) esomeprazole (20 mg qd) plus clopidogrel or (2) clopidogrel treatment alone for 6 months.

Exclusion Criteria:

- 1.serious disease 2.refuse informed consent

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• esomeprazole
esomeprazole 20 mg qd for 6 months

Locations
Country Name City State
Taiwan Kaohsiung Veterans General Hospital Kaohsiung

Sponsors (1)
Lead Sponsor Collaborator
Kaohsiung Veterans General Hospital.

Country where clinical trial is conducted

Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Recurrent Peptic Ulcer Number of participants with recurrent peptic ulcer within 6 months 6 months No
Secondary Peptic Ulcer Bleeding participants with peptic ulcer bleeding within 6 months 6 months No
See also
  Status Clinical Trial Phase
Recruiting NCT00471029 - Compare Efficacy of Gastric Acid Suppression by Oral and Intravenous Administration of Esomeprazole in Patients With Peptic Ulcer Phase 4
Completed NCT00152399 - Study to Assess the Efficacy and Safety of Somatostatin in the Treatment of Acute Severe Upper Gastrointestinal Bleeding Phase 2
Not yet recruiting NCT02961296 - Helicobacter Pylori Antibiotic Susceptibility Testing of Korea N/A
Completed NCT00212225 - Risk Factors for Gastric Disease in Pediatric Helicobacter Pylori (H. Pylori) N/A
Completed NCT02342470 - Efficacy and Safety of PMK-S005 in the Prevention of Recurrent Peptic Ulcer in Low-dose Aspirin Users Phase 2
Completed NCT02296021 - Helicobacter Pylori Eradication With Berberine Quadruple Therapy Versus Bismuth-containing Quadruple Therapy Phase 4
Completed NCT00977678 - Drop in Gastroscopy - Experience After 9 Months N/A
Terminated NCT04025983 - Effectiveness of GastimunHp Plus in Supporting the Treatment of Peptic Ulcer Disease With Helicobacter Pylori Infection N/A
Recruiting NCT03868267 - Japanese Upper GI Symptoms Compared With Iranian and Canadian Patients Presenting
Completed NCT05237115 - Helicobacter Pylori Eradication With Probiotics Combined With Triple Therapy Versus Bismuth-containing Quadruple Therapy Phase 4
Completed NCT01667718 - Bismuth Improves the Efficacy of Levofloxacin-containing Triple Therapy for Helicobacter Pylori Treatment Phase 4
Not yet recruiting NCT04784910 - Study to Evaluate the Efficacy and Safety of DWP14012 in Prevention of NSAIDs Induced Peptic Ulcer Phase 3
Recruiting NCT02436018 - WEI NASAL JET for The Sedation of Outpatient Upper Gastrointestinal Endoscopy N/A
Completed NCT03367897 - Bleeding Ulcer and Erosions Study "BLUE Study"
Active, not recruiting NCT02001727 - HEP-FYN 12-Years Follow-up N/A
Completed NCT01667692 - Aizthromycin or Clarithromycin in H-pylori Eradication Regimen Phase 4
Completed NCT01376414 - H. Pylori Testing for Patients With Non-specific Upper Abdominal Pain in the Emergency Department N/A
Completed NCT01080326 - Feasibility of Translumenal Endoscopic Omental Patch Closure of Perforated Viscus N/A
Completed NCT02536989 - Different Dose of Intravenous Omeprazole to Treat Bleeding Ulcer With Adherent Clot Phase 4
Completed NCT00920400 - Diagnostic Value of Fecal Calprotectin in Disorders of the Upper Gastrointestinal Tract N/A