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

Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00534677
• Other study ID #: 297-Med/ERC-04
• Status: Completed
• Phase: Phase 4
• First received: September 24, 2007
• Last updated: December 4, 2007
• Start date: May 2004
• Est. completion date: July 2005

Study information

• Verified date: September 2007
• Source: Aga Khan University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Pakistan: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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).

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 320
• Est. completion date: July 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cirrhosis
• Hematemesis
• Hypertension, Portal
• Melena
• Portal Hypertension

Intervention

Drug:
• Terlipressin
2 mg stat & then 1 mg q6h iv and Placebo of Octreotide
• Octreotide
Octreotide 50mcg/hr infusion & a placebo of Terlipressin

Locations

Country	Name	City	State
Pakistan	The Aga Khan University Hospital	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Aga Khan University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety & Efficacy		5 days	Yes