A Double Blind Study Comparing Two Doses of IV Esomeprazole After Successful Endoscopic Therapy
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
A bleeding peptic ulcer remains a serious medical problem with significant morbidity and mortality. Endoscopic therapy significantly reduces further bleeding, surgery, and mortality in patients with bleeding peptic ulcers and is now recommended as the first hemostatic modality for these patients.
In the past few years, adjuvant use of a high-dose proton pump inhibitor (PPI) after endoscopic therapy has been endorsed in some studies. However, low dose of PPI has also been supported in the management of these patients.
The investigators enroll 130 patients with active bleeding or nonbleeding visible vessels in this study. They are randomly assigned as 40 mg/day or 160mg/day IV nexium group. All patients receive successful endoscopic therapy with heater probe or hemoclip placement.
In the low dose group (N=65), 40 mg IV Nexium daily is given for three days. Thereafter, the patients receive 40 mg nexium orally daily for two months. In the large dose group (N=65), 160 mg/day continuous infusion is given for three days. Thereafter, the patients receive 40 mg nexium orally daily for two months.
The primary end point is recurrent bleeding before discharge and within 14 days. At day 14, volume of blood transfused, number of surgeries performed, and the mortality rates of the two groups are compared as well.
| Condition | Intervention | Phase |
|---|---|---|
|
Upper Gastrointestinal Bleeding |
Drug: Esomeprazole Drug: esomeprazole |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Double Blind Study Comparing Low Dose and High Dose IV Esomeprazole After Successful Endoscopic Therapy in Patients With Peptic Ulcer Bleeding |
- Two different doses intravenous proton pump inhibitors in patients with peptic ulcer bleeding after successful endoscopic therapy- a prospective randomized comparative trial. [ Time Frame: two years ] [ Designated as safety issue: Yes ]recurrent bleeding before discharge and within 14 days
- Two different doses intravenous proton pump inhibitors in patients with peptic ulcer bleeding after successful endoscopic therapy- a prospective randomized comparative trial. [ Time Frame: two years ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 65 |
| Study Start Date: | August 2011 |
| Estimated Study Completion Date: | January 2014 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Esomeprazole
Esomeprazole 40 mg IV daily is given for three days followed by40mg once daily orally for two months.
|
Drug: Esomeprazole
Esomeprazole 40 mg IV daily is given for three days. Thereafter, the patients receive 40 mg Esomeprazole orally daily for two months.
Other Name: Esomeprazole
|
|
Active Comparator: esomeprazole
esomeprazole 160 mg/day continuous infusion is given for three days followed by 40mg once daily orally for two months.
|
Drug: Esomeprazole
Esomeprazole 40 mg IV daily is given for three days. Thereafter, the patients receive 40 mg Esomeprazole orally daily for two months.
Other Name: Esomeprazole
Drug: esomeprazole
esomeprazole 160 mg/day continuous infusion is given for three days. Thereafter, the patients receive 40 mg nexium orally daily for two months.
Other Name: nexium
|
Detailed Description:
A bleeding peptic ulcer remains a serious medical problem with significant morbidity and mortality. Endoscopic therapy significantly reduces further bleeding, surgery, and mortality in patients with bleeding peptic ulcers and is now recommended as the first hemostatic modality for these patients.
In the past few years, adjuvant use of a high-dose proton pump inhibitor (PPI) after endoscopic therapy has been endorsed in some studies. However, low dose of PPI has also been supported in the management of these patients.
We enroll 130 patients with active bleeding or nonbleeding visible vessels in this study. They are randomly assigned as 40 mg/day or 160mg/day IV nexium group. All patients receive successful endoscopic therapy with heater probe or hemoclip placement.
In the low dose group (N=65), 40 mg IV Nexium daily is given for three days. Thereafter, the patients receive 40 mg nexium orally daily for two months. In the large dose group (N=65), 160 mg/day continuous infusion is given for three days. Thereafter, the patients receive 40 mg nexium orally daily for two months.
The primary end point is recurrent bleeding before discharge and within 14 days. At day 14, volume of blood transfused, number of surgeries performed, and the mortality rates of the two groups are compared as well.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- a peptic with active bleeding, a non-bleeding visible vessel or an adherent blood clot at the ulcer base is observed within24 hours of hospital admission
Exclusion Criteria:
- Patients are excluded from the study if they are pregnant, do not obtain initial hemostasis with endoscopic injection epinephrine, do not give written informed consent,have bleeding tendency(platelet count <50*109/L,serum prothrombin <30% of normal, or were taking anticoagulants), uremia
Contacts and Locations| Contact: Hwai-jeng Lin, Doctor | 886-2-27372181 | buddhistlearning@gmail.com |
| Taiwan | |
| Taipei Medical University Hospital | Recruiting |
| Taipei, Taiwan, 110 | |
| Contact: Hwai-jeng Lin, M.D. 886-2-27372181 ext 3040 buddhistlearning@gmail.com | |
| Principal Investigator: Hwai-jeng Lin, M.D. | |
| Study Chair: | Hwai-jeng Lin, MD | Taipei Medical University |
More Information
No publications provided
| Responsible Party: | Lin Hwai-Jeng, Taipei Medical University |
| ClinicalTrials.gov Identifier: | NCT01275937 History of Changes |
| Other Study ID Numbers: | TMUH-2011 |
| Study First Received: | January 12, 2011 |
| Last Updated: | August 11, 2011 |
| Health Authority: | Taiwan: Institutional Review Board |
Additional relevant MeSH terms:
|
Gastrointestinal Hemorrhage Hemorrhage Gastrointestinal Diseases Digestive System Diseases Pathologic Processes Omeprazole |
Anti-Ulcer Agents Gastrointestinal Agents Therapeutic Uses Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on October 18, 2012
