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

Primary Purpose

Delayed Bleeding,, Healing Ulcer, Quality of Ulcer

Status

Unknown status

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Ecabet

About this trial

This is an interventional treatment trial for Delayed Bleeding,

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Samsung Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

PPI+placebo

PPI+ES

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT01308177

First Posted

March 2, 2011

Last Updated

March 2, 2011

Sponsor

Samsung Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT01308177

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

March 2011

Overall Recruitment Status

Unknown status

Study Start Date

March 2011 (undefined)

Primary Completion Date

March 2012 (Anticipated)

Study Completion Date

March 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Samsung Medical Center

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Delayed Bleeding,, Healing Ulcer, Quality of Ulcer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

PPI+placebo

Arm Type

Placebo Comparator

Arm Title

PPI+ES

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Ecabet

Intervention Description

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

Primary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

Samsung Medical Center

City

Seoul

Country

Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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