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

NCT ID: NCT01308177

Last Updated: 2011-03-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2012-03-31

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.

Conditions

Delayed Bleeding,; Healing Ulcer; Quality of Ulcer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

PPI+placebo

Group Type: PLACEBO_COMPARATOR

Ecabet

Intervention Type: DRUG

comparison between PPI+ ES (lanston 30mg bid+ ES 1g/1.5g/pkg bid) and PPI+placebo (lanston 30mg bid)for 28 days

PPI+ES

Group Type: ACTIVE_COMPARATOR

Ecabet

Intervention Type: DRUG

comparison between PPI+ ES (lanston 30mg bid+ ES 1g/1.5g/pkg bid) and PPI+placebo (lanston 30mg bid)for 28 days

Interventions

Ecabet

comparison between PPI+ ES (lanston 30mg bid+ ES 1g/1.5g/pkg bid) and PPI+placebo (lanston 30mg bid)for 28 days

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Samsung Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Samsung Medical Center

Locations

Samsung Medical Center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

2010-10-044

Identifier Type: -

Identifier Source: org_study_id