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 ]
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 ]
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