Trial Outcomes & Findings for Effect of High-dose Oral Rabeprazole on Recurrent Bleeding After the Endoscopic Treatment of Bleeding Peptic Ulcers (NCT NCT00838682)
NCT ID: NCT00838682
Last Updated: 2010-09-24
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
106 participants
Primary outcome timeframe
day 3
Results posted on
2010-09-24
Participant Flow
1. Location: Uijeongbu St. Mary's hospital and Bucheon St. Mary's hospital, The Catholic University of Korea 2. Period: from April 1, 2006 to April 19, 2007 and from October 1, 2007 to December 31, 2008.
Patients who presented with overt or suspected upper gastrointestinal bleeding were eligible. These eligible patients were required to have an high-risk bleeding peptic ulcer on emergent endoscopy performed within 24 hours after the hospitalization. Among those, patients who achieved primary hemostasis with endoscopic hemostatic treatment.
Participant milestones
| Measure |
Rabeprazole Sodium
Oral Rabeprazole 20 mg twice daily for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy.
|
Omeprazole
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.
|
|---|---|---|
|
Overall Study
STARTED
|
54
|
52
|
|
Overall Study
COMPLETED
|
29
|
33
|
|
Overall Study
NOT COMPLETED
|
25
|
19
|
Reasons for withdrawal
| Measure |
Rabeprazole Sodium
Oral Rabeprazole 20 mg twice daily for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy.
|
Omeprazole
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
21
|
14
|
|
Overall Study
detection of exclusion criteria
|
4
|
3
|
|
Overall Study
Protocol Violation
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Effect of High-dose Oral Rabeprazole on Recurrent Bleeding After the Endoscopic Treatment of Bleeding Peptic Ulcers
Baseline characteristics by cohort
| Measure |
Rabeprazole Sodium
n=54 Participants
Oral Rabeprazole 20 mg twice daily for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy.
|
Omeprazole
n=52 Participants
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.
|
Total
n=106 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
56.1 years
STANDARD_DEVIATION 16.2 • n=5 Participants
|
57.1 years
STANDARD_DEVIATION 15.8 • n=7 Participants
|
56.6 years
STANDARD_DEVIATION 16.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
|
Region of Enrollment
Korea, Republic of
|
54 participants
n=5 Participants
|
52 participants
n=7 Participants
|
106 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: day 3Population: intention to treat (ITT)
Outcome measures
| Measure |
Rabeprazole Sodium
n=54 Participants
Oral Rabeprazole 20 mg twice daily for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy.
|
Omeprazole
n=52 Participants
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.
|
|---|---|---|
|
Rebleeding Within 3 Days
|
2 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 6wkPopulation: intention to treat (ITT)
Rebleeding after 3 days was assessed by checking the patients from day 3 to discharge and bleeding event or regular follow-up after discharge to week 6.
Outcome measures
| Measure |
Rabeprazole Sodium
n=54 Participants
Oral Rabeprazole 20 mg twice daily for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy.
|
Omeprazole
n=52 Participants
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.
|
|---|---|---|
|
Rebleeding After 3 Days
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 6wkPopulation: intention to treat (ITT)
This sencodary endpoint "surgery" is the operation for bleeding control of peptic ulcer bleeding such as gastric or duodenal primary closure, and subtotal gastrectomy with/without vagotomy.
Outcome measures
| Measure |
Rabeprazole Sodium
n=54 Participants
Oral Rabeprazole 20 mg twice daily for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy.
|
Omeprazole
n=52 Participants
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.
|
|---|---|---|
|
Surgery
|
2 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 6wkPopulation: intention to treat (ITT)
Outcome measures
| Measure |
Rabeprazole Sodium
n=54 Participants
Oral Rabeprazole 20 mg twice daily for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy.
|
Omeprazole
n=52 Participants
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.
|
|---|---|---|
|
Death
|
1 participants
|
0 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: day 3Population: intention to treat (ITT)
In order to compare the total amount of blood transfusion, mean units of blood transfusion was used.
Outcome measures
| Measure |
Rabeprazole Sodium
n=54 Participants
Oral Rabeprazole 20 mg twice daily for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy.
|
Omeprazole
n=52 Participants
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.
|
|---|---|---|
|
Mean Units of Blood Transfusion
|
1.3 Mean units of blood transfusion
Standard Deviation 1.4
|
1.4 Mean units of blood transfusion
Standard Deviation 1.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6wkPopulation: intention to treat (ITT)
Outcome measures
| Measure |
Rabeprazole Sodium
n=54 Participants
Oral Rabeprazole 20 mg twice daily for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy.
|
Omeprazole
n=52 Participants
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.
|
|---|---|---|
|
Duration of Hospital Stay
|
8.0 days
Standard Deviation 5.6
|
6.7 days
Standard Deviation 2.1
|
Adverse Events
Rabeprazole Sodium
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Omeprazole
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Rabeprazole Sodium
n=54 participants at risk
Oral Rabeprazole 20 mg twice daily for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy.
|
Omeprazole
n=52 participants at risk
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.
|
|---|---|---|
|
Hepatobiliary disorders
hepatic enzyme elevation
|
1.9%
1/54 • Number of events 1 • week 6
|
1.9%
1/52 • Number of events 1 • week 6
|
|
Nervous system disorders
tonic seizure like activity
|
1.9%
1/54 • Number of events 1 • week 6
|
0.00%
0/52 • week 6
|
|
Cardiac disorders
Ventricular premature beats
|
0.00%
0/54 • week 6
|
1.9%
1/52 • Number of events 1 • week 6
|
Additional Information
Hiun-Suk Chae
The Catholic University of Korea, Uijeongbu St. Mary's Hospital
Phone: 82-31-820-3019
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place