NCT00838682

Brief Summary

This study is conducted to compare and evaluate the effect of administering a high-dose intravenous proton pump inhibitors or high-dose oral Rabeprazole in preventing recurrent bleeding after the endoscopic treatment of bleeding peptic ulcers.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Apr 2006

Typical duration for phase_4

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 5, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 6, 2009

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

September 24, 2010

Completed
Last Updated

September 24, 2010

Status Verified

August 1, 2010

Enrollment Period

2.8 years

First QC Date

February 5, 2009

Results QC Date

August 2, 2010

Last Update Submit

August 31, 2010

Conditions

Peptic Ulcer Hemorrhage

Keywords

peptic ulcer bleedingrabeprazoleproton pump inhibitor

Outcome Measures

Primary Outcomes (1)

  • Rebleeding Within 3 Days

    day 3

Secondary Outcomes (3)

  • Rebleeding After 3 Days

    6wk

  • Surgery

    6wk

  • Death

    6wk

Other Outcomes (2)

  • Mean Units of Blood Transfusion

    day 3

  • Duration of Hospital Stay

    6wk

Study Arms (2)

rabeprazole sodium

EXPERIMENTAL

Oral Rabeprazole 20 mg twice daily for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy.

Drug: Rabeprazole

Omeprazole

ACTIVE COMPARATOR

Intravenous Omeprazole 80 mg as a bolus injection followed by continuous infusion at 8 mg per hour for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy.

Drug: omeprazole sodium IV

Interventions

omeprazole sodium IVDRUG

Intravenous Omeprazole (brand name: Losec® injection 40 mg) 80 mg as a bolus injection followed by continuous infusion at 8 mg per hour for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy.

Also known as: Losec IV
Omeprazole
RabeprazoleDRUG

Oral Rabeprazole 20 mg twice daily for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy.

Also known as: Pariet
rabeprazole sodium

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Bleeding peptic ulcer: Among patients suspected to have upper GI bleeding based on hematemesis or melena, those with peptic ulcers(Forrest I, IIa and IIb) in whom active bleeding, non-bleeding visible vessels and fresh blood clots are observed on upper GI endoscopy performed within 24 hours after the hospitalization
  • patients who achieved primary hemostasis with endoscopic hemostasis procedure via upper GI endoscopy

You may not qualify if:

  • Patients who refuse endoscopic procedure
  • Patients with complications from gastric ulcer that require operative treatment prior to upper GI endoscopic treatment(e.g., gastric outlet obstruction, peptic ulcer perforation)
  • Pregnancy
  • Patients with serious concurrent diseases such as malignant tumors or end-stage diseases
  • History of previous gastrectomy or vagotomy
  • Known hypersensitivity to proton pump inhibitors
  • Elderly patients
  • Epilepsy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Bucheon St. Mary's Hospital

Bucheon-si, Kyungkido, South Korea

Location

Uijeongbu St.Mary's Hospital

Uijeongbu-si, Kyungkido, South Korea

Location

MeSH Terms

Conditions

Peptic Ulcer Hemorrhage

Interventions

Rabeprazole

Condition Hierarchy (Ancestors)

Gastrointestinal HemorrhageGastrointestinal DiseasesDigestive System DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Limitations and Caveats

This was the two-center study and was stopped before the complete enrollment leading to small numbers of subjects statistically underpowered.

Results Point of Contact

Title
Hiun-Suk Chae
Organization
The Catholic University of Korea, Uijeongbu St. Mary's Hospital
chs@catholic.ac.kr
82-31-820-3019

Study Officials

  • Hiun-Suk Chae, Professor

    The Catholic University of Korea

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 5, 2009

First Posted

February 6, 2009

Study Start

April 1, 2006

Primary Completion

January 1, 2009

Study Completion

March 1, 2009

Last Updated

September 24, 2010

Results First Posted

September 24, 2010

Record last verified: 2010-08

Locations

KR(2)