Clinical trial NCT00838682: Effect of High-dose Oral Rabeprazole on Recurrent Bleeding After the Endoscopic Treatment of Bleeding Peptic Ulcers
Official title: Effect of High-dose Oral Rabeprazole on Recurrent Bleeding After the Endoscopic Treatment of Bleeding Peptic Ulcers
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Peptic Ulcer Hemorrhage
Keywords: peptic ulcer bleeding
rabeprazole
proton pump inhibitor
Lead sponsor: The Catholic University of Korea
Sponsor class: OTHER
Collaborators: name: Janssen Korea, Ltd., Korea
First posted: 2009-02-06
Enrollment: 106
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 0.1 % of hospitalized patients are attributed to upper gastrointestinal bleeding every year in the U.S. and Europe, among which peptic ulcer is the most common cause of upper gastrointestinal bleeding. Endoscopic hemostasis procedure in the management of bleeding due to peptic ulcers was safe as well as effective and lowered recurrent bleeding, surgery and mortality. Endoscopic treatment is widely used as an effective and safe method but it has disadvantages including the need for the endoscopy specialist and the likelihood of developing the complications such as perforation or recurrent bleeding although they rarely occur. Thus, less invasive medical treatments with fewer side effects have been continuously studied and among them, gastric acid inhibitors have been studied the most.Acid and pepsin inhibit platelet aggregation, activation of blood coagulation system, and fibrinogen polymerization. Blood clots already formed are digested by pepsin and the activity of pepsin is closely related to intragastric pH level. Therefore, it is known that an elevated intragastric pH facilitates hemostasis process, induces hemostasis by stabilizing hematoma and prevents recurrent bleeding. To suffice these conditions, it is reported that a potent gastric acid inhibitor is needed to maintain intragastric pH of 6 or higher.

For the treatment of bleeding peptic ulcers, the intravenous administration of a high-dose proton pump inhibitor after the initial endoscopic treatment has shown a decline in the frequency of recurrent bleeding as well as surgery. Recent studies reported that the use of oral proton pump inhibitor was effective under certain circumstances in the treatment of bleeding peptic ulcers. However, to date, no study has been conducted to compare the effect of a high-dose intravenous proton pump inhibitor with that of oral Rabeprazole after endoscopic treatment of bleeding peptic ulcers. Therefore, in this study, after administering a high-dose intravenous proton pump inhibitor or high-dose oral Rabeprazole in preventing recurrent bleeding following endoscopic treatment of bleeding peptic ulcers, we are going to compare the rate of recurrent bleeding between the two groups as well as to compare and evaluate the surgery rate, mortality rate and the number of days of hospital stay.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Rebleeding Within 3 Days
timeFrame: day 3
Secondary outcomes:
measure: Rebleeding After 3 Days
timeFrame: 6wk
measure: Surgery
timeFrame: 6wk
measure: Death
timeFrame: 6wk
Other outcomes:
measure: Mean Units of Blood Transfusion
timeFrame: day 3
measure: Duration of Hospital Stay
timeFrame: 6wk
Locations:
city: Bucheon
country: Korea, Republic of
facility: Bucheon St. Mary's Hospital
state: Kyungkido
city: Uijeongbu
country: Korea, Republic of
facility: Uijeongbu St.Mary's Hospital
state: Kyungkido
Study officials:
affiliation: The Catholic University of Korea
name: Hiun-Suk Chae, Professor
role: PRINCIPAL_INVESTIGATOR
References: