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OpenTrials
Completed

NCT Number: NCT00534677

The Safety & Efficacy of Terlipressin vs Octreotide for the Control of Variceal Bleed

Terlipressin and Octreotide are two common agents used as adjuvants in the management of variceal bleeding. Both agents have been claimed equivalent to endoscopic therapy in randomized studies. There are no head to head clinical trials of these two agents available in the literature. We aimed to compare the efficacy and safety of Terlipressin and Octreotide in combination with Endoscopic Variceal band Ligation (EVL)in patients presenting with Esophageal Variceal Bleed (EVB).

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Key information

Conditions

Portal Hypertension Cirrhosis Digestive System Diseases Fibrosis Gastrointestinal Diseases Gastrointestinal Hemorrhage Hematemesis Hemorrhage Hypertension, Portal Liver Diseases Melena Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The Aga Khan University Hospital

Karachi, Sindh, 74800, Pakistan

About this study

The effectiveness of combining Endoscopic treatment with Octreotide or Terlipressin has not been prospectively studied in esophageal variceal hemorrhage (EVH).

This prospective, randomized clinical trial will help us in better patient management more efficiently and cost effectively.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All cirrhotic patients with upper GI bleed secondary to esophageal varices of 18 years or more of age

Exclusion criteria

  • Ulcerative esophagitis,
  • Mallory Weiss tear,
  • Bleeding gastric or duodenal ulcers,
  • Bleeding from gastric varices or portal hypertensive gastropathy and
  • Upper GI bleed as a result of thrombocytopenia or bleeding diathesis.

Treatment and study plan

Terlipressin

Drug

2 mg stat & then 1 mg q6h iv and Placebo of Octreotide

Other names: Novapresin

Octreotide

Drug

Octreotide 50mcg/hr infusion & a placebo of Terlipressin

Other names: sandostatin

Primary outcomes

  1. Safety & Efficacy

    Time frame: 5 days

Sponsors and collaborators

Lead sponsor

Aga Khan University

Other

Registry information

Official study title

Efficacy And Safety Of Terlipressin Vs Octreotide As Adjuvant Therapy In Bleeding Esophageal Varices

Important dates

Study start
2004
Study completion
2005
First posted
Sep 26, 2007
Registry last updated
Dec 5, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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