NCT00152399

Study to Assess the Efficacy and Safety of Somatostatin in the Treatment of Acute Severe Upper Gastrointestinal Bleeding

A Multicenter, Randomized, Double-Blind, Placebo Controlled Trial To Study The Efficacy And The Safety Of The Early Administration Of Somatostatin (Ucb) 12 Mg/24 H IV Infusion And Two IV Boluses Of 250 Mcg During 72 Hours In The Treatment Of Subjects With Acute Severe Upper Gastrointestinal Bleeding (UGIB) With Suspicion Of Peptic Ulcer Bleeding [The PUB Study]

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 370 (planned)
• Sponsor: UCB Pharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To assess the efficacy and safety of the early administration of somatostatin in infusion during 72 hours plus 2 boluses, compared to placebo in the control of acute severe UGIB with suspicion of PUB.

Conditions

• Peptic Ulcer

Interventions

Type	Name	Description
DRUG	Somatostatin UCB (drug)

Timeline

• Start date: 2000-09-01
• Primary completion: 2005-10-01
• Completion: 2005-10-01
• First posted: 2005-09-09
• Last updated: 2012-09-18

Locations

22 sites across 6 countries: Belgium, France, Greece, Hungary, Poland, Spain