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

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UCB

Status and phase

Completed
Phase 2

Conditions

Peptic Ulcer

Treatments

Drug: Somatostatin UCB (drug)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00152399
9823

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Male or female non-cirrhotic patients at least 18 years old suspected to bleed from PU.
  • Patients with haematemesis and/or hematochezia and/or melena which have been observed by a member of a clinical team (GP, hospital physician, nurse, ...).
  • Either, documented signs of hypovolemia related to the current bleeding episode Or, occurrence of symptoms of hypovolemia

Exclusion criteria

  • Treatment of the present bleeding episode with somatostatin or its analogues, vasoactive drugs, or endoscopic therapy.
  • Any treatment with PPIs (IV or per os) within the last 48 hours preceding randomisation.
  • Treatment (endotherapy or pharmacotherapy) for upper gastrointestinal ulcer bleeding in the last 30 days.
  • Deficient haemostasis (platelets < 40 x 109/l, international normalised ratio of the prothrombin time > 1.5 (or prothrombin time < 70%), or activated partial thromboplastin time > 40 seconds (or according to the normal ranges validated, from local lab))
  • Anticoagulant therapy (vitamin K antagonists or heparin including LMW heparins)
  • Terminal stage illness in which endoscopy is contraindicated

Trial contacts and locations

22

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Data sourced from clinicaltrials.gov

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