NCT01757275

A Multi-center, Randomised, Double-blind, Parallel-group Phase III Study to Assess High Dose Esomeprazole Na i.v. Treatment (Bolus Infusion of 80 mg Followed by a Continuous Infusion of 8 mg Per Hour Administered for 72 Hours) for Prevention of Rebleeding

Completed Phase 3 Results posted Last updated 9 February 2016

What this trial tests

Phase 3 trial testing Esomeprazole Na in Bleeding Peptic Ulcer in 239 participants. Completed in 1 December 2014.

Timeline

1 February 2013

Primary endpoint
1 December 2014

1 December 2014

Quick facts

Lead sponsor	AstraZeneca
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	239
Start date	1 February 2013
Primary completion	1 December 2014
Estimated completion	1 December 2014
Sites	12 locations across China

Drugs / interventions tested

• Esomeprazole Na — full drug profile →
• Cimetidine (CIMETIDINE) — full drug profile →
• Esomeprazole Mg — full drug profile →

Conditions studied

• Bleeding Peptic Ulcer — all drugs for Bleeding Peptic Ulcer →

Sponsor

AstraZeneca — full company profile →

Who can join

Adults 18 to 70, any sex, with Bleeding Peptic Ulcer. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Rate of Clinically Significant Rebleeding Within 72 Hours
  Time frame: 72 hours
  Diagnostic criteria for clinically significant rebleeding based on either A, B or C: A) Endoscopy - initiated by clinical signs of bleeding defined as one of B1 or B2 or B3 and endoscopic verification, ie one of A1 or A2. A1: Blood in stomach (this criteria cannot be used during the first 6 hours after primary endoscopic haemostasis). A2: A verified active bleeding from a peptic ulcer (Forrest I

Sponsor's own description

To describe the rate of clinically significant rebleeding during 72 hours continuous i.v. infusion of high dose esomeprazole Na in patients in China with primary successful endoscopic haemostatic therapy of a bleeding peptic ulcer, with cimetidine i.v. in

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Intravenous Esomeprazole for Prevention of Peptic Ulcer Rebleeding: A Randomized Trial in Chinese Patients.
   Bai Y, Chen DF, Wang RQ, Chen YX, et al · · 2015 · cited 7× · PMID 26581750 · DOI 10.1007/s12325-015-0265-6