Clinical Trial: Long-term Oral Esomeprazole for Prevention of Peptic Ulcer Rebleeding in High-risk Patients

Study Status: Terminated
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Secondary Prevention With Long-term Oral Esomeprazole for Peptic Ulcer Recurrence and Rebleeding in High-risk Rockall Scores ≥ 6 Patients

Brief Summary: The purpose of this study is to determine whether a long-term prophylactic use of esomeprazole 20 mg twice daily or once daily has prevention effectiveness in reducing the recurrence of peptic ulcer bleeding after ulcer healed with 16-week oral esomeprazole therapy in high-risk patients whose Rockall score ≥ 6.

Detailed Summary:

This study is conducted at the inpatient wards of National Cheng Kung University Hospital, a tertiary health care center in Tainan, Taiwan. All participants give written informed consent before enrollment. Each enrolled patient receives an 80 mg loading dose of intravenous esomeprazole (Nexium®, AstraZeneca AB, Södertälje, Sweden) immediately after achieving haemostasis by gastroscopy. Patients then receive a 3-day continuous high-dose (8 mg/h) esomeprazole infusion and then receive 40 mg oral esomeprazole twice daily for 11 days and once daily for following 98 days. The total duration of intravenous and oral esomeprazole is 16 weeks. After gastroscopy to confirm enrollment eligibility and ulcer healed, all patients are assessed using the Rockall risk scoring system at the primary endoscopy. Patients with Rockall scores ≥ 6 are randomized into the double-dose (D) group or the single-dose (S) group following simple randomization procedures with a 1:1 allocation ratio according to the result by the investigator who draw an envelope from a large box of sealed envelopes each containing a written code designating the D group or the S group. Patients in the D group and S groups receive 20 mg oral esomeprazole twice daily or once daily for 36 weeks, respectively. The cohort control group includes patients from a previous study who had peptic ulcer bleeding and Rockall scores ≥ 6 but who did not receive esomeprazole or other proton pump inhibitors after 16-week proton pump inhibitor treatment.

One investigator generates the random allocation sequence and enrolls the participants and a different investigator assigns participants to interventions. The endoscopists and staff who check hemoglobin levels, hemodynamic status, melena, hematochezia or the aspirates through a nasogastric tube are blinded to the study group allocation. All enrolled patients are i
Sponsor: Hsiu-Chi Cheng

Current Primary Outcome: The recurrent bleeding [ Time Frame: 52 weeks ]

The recurrent bleeding is defined as 1) recurrent melena, haematochezia, the presence of bloody aspirates through a nasogastric tube and 2) relapse of haemodynamic instability, including systolic blood pressure <90 mm Hg, heart rate >120 bpm or a drop in haemoglobin concentration of >2 g/dL, or sudden increase in transfusion requirements. For each patient with either suspected or active rebleeding, the hemoglobin level and gastroscopy are performed to confirm any blood or coffee-ground-like materials in the stomach, or the persistence of stigmata indicating recent haemorrhage. The gastroscopy also determines whether the source of rebleeding was a peptic ulcer or some other non-ulcer bleeding source, such as varices.


Original Primary Outcome: Same as current

Current Secondary Outcome: The recurrence of peptic ulcer confirmed by follow-up endoscopy [ Time Frame: between the 17th and 52th weeks ]

In each patient, the follow-up endoscopy will be performed during the period between the 17th and 52th weeks and the definition of recurrence of ulcer is the size of ulcer > 0.5 cm.


Original Secondary Outcome: Same as current

Information By: National Cheng-Kung University Hospital

Dates:
Date Received: May 25, 2015
Date Started: May 2015
Date Completion: May 2017
Last Updated: May 25, 2015
Last Verified: May 2015