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Efficacy of Ecabet Sodium and Proton Pump Inhibitor Combination Therapy in the Treatment of Iatrogenic Ulcer After Endoscopic Submucosal Dissection

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ClinicalTrials.gov Identifier: NCT01308177
Recruitment Status : Unknown
Verified March 2011 by Samsung Medical Center.
Recruitment status was:  Enrolling by invitation
First Posted : March 3, 2011
Last Update Posted : March 3, 2011
Sponsor:
Information provided by:
Samsung Medical Center

Brief Summary:
  • Endoscopic submucosal dissection (ESD) is widely indicated to treat gastric adenomas and early gastric cancer (EGC).ESD is able to obtain en bloc resection of larger specimens. However, ESD has more frequent complications (delayed bleeding, ulcer healing, ulcer pain, and etc) due to a more complex procedure. To prevent delayed bleeding, to induce rapid ulcer healing, and to control the ulcer pain acid-suppressing agents (PPI, H2RA) are generally administered. although PPIs are widely indicated as first-line drugs for peptic ulcers, PPI drugs are not fully superior to H2RAs or other combination drugs for treatment of iatrogenic ulcer healing and delayed bleeding.
  • Ecabet sodium (ES)is a widely used mucoprotective agent for the treatment of gastric ulcers. Recently, one study showed the additional benefits of using ES in combination with the PPI after ESD. however, this study did not show the difference of delayed bleeding and the benefit of ulcer pain control. thus, our study prospectively evaluated the difference of delayed bleeding and the benefit of ulcer pain control after ESD.

Condition or disease Intervention/treatment Phase
Delayed Bleeding, Healing Ulcer Quality of Ulcer Drug: Ecabet Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of an Ecabet Sodium and Proton Pump Inhibitor (PPI) Combination Therapy in the Treatment of Iatrogenic Ulcer After Endoscopic Submucosal Dissection: A Prospective Randomized Controlled Trial
Study Start Date : March 2011
Estimated Primary Completion Date : March 2012
Estimated Study Completion Date : March 2012

Arm Intervention/treatment
Placebo Comparator: PPI+placebo Drug: Ecabet
comparison between PPI+ ES (lanston 30mg bid+ ES 1g/1.5g/pkg bid) and PPI+placebo (lanston 30mg bid)for 28 days
Active Comparator: PPI+ES Drug: Ecabet
comparison between PPI+ ES (lanston 30mg bid+ ES 1g/1.5g/pkg bid) and PPI+placebo (lanston 30mg bid)for 28 days



Primary Outcome Measures :
  1. to determine the difference in delayed bleeding with PPI or PPI+ES [ Time Frame: the time of bleeding occured or post 4 weeks after ESD ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • gastric adenomas or differentiated EGC (any size without ulcers or signs of submucosal invasion; intramucosal differentiated-type EGC < 3 cm with a scar; and no lymph node involvement or metastasis by CT)

Exclusion Criteria:

  • recent use of a PPI, H2RA, bismuth, and antibiotics
  • current use of aspirin, non-steroidal anti-inflammatory drugs, or corticosteroids
  • Helicobacter pylori infection not evaluated appropriately by endoscopic biopsy and serology
  • a history of subtotal gastrectomy; patients who underwent surgery due to ESD complications; known hypersensitivity to PPIs
  • chronic co-morbid disease, such as chronic liver and renal disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01308177


Locations
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Samsung Medical Center

Responsible Party: Jaej Kim, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01308177     History of Changes
Other Study ID Numbers: 2010-10-044
First Posted: March 3, 2011    Key Record Dates
Last Update Posted: March 3, 2011
Last Verified: March 2011

Additional relevant MeSH terms:
Ulcer
Pathologic Processes
Proton Pump Inhibitors
Ecabet
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Protease Inhibitors
Anticarcinogenic Agents
Protective Agents
Physiological Effects of Drugs
Antineoplastic Agents