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

NCT01308177 | Unknown Phase 4

• 1 other identifier: 2010-10-044
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• to determine the difference in delayed bleeding with PPI or PPI+ES

  the time of bleeding occured or post 4 weeks after ESD

Study Arms (2)

PPI+placebo

PLACEBO COMPARATOR

Drug: Ecabet

PPI+ES

ACTIVE COMPARATOR

Drug: Ecabet

Interventions

Ecabet 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; PPI+placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

MeSH Terms

Interventions

ecabet

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 2, 2011
• First Posted: March 3, 2011
• Study Start: March 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: March 3, 2011

Record last verified: 2011-03

Locations

KR (1)