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

Tracking Information

First Received Date ^ICMJE

September 24, 2007

Last Updated Date

December 4, 2007

Start Date ^ICMJE

May 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Safety & Efficacy [ Time Frame: 5 days ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Safety & Efficacy [ Time Frame: 5 days ]

Change History

Complete list of historical versions of study NCT00534677 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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).

Detailed 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.

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Portal Hypertension
Cirrhosis
Hematemesis
Melena

Intervention ^ICMJE

Drug: Terlipressin
Drug: Octreotide

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

320

Completion Date

July 2005

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Pakistan

Administrative Information

NCT ID ^ICMJE

NCT00534677

Responsible Party

Dr. Shahab Abid, The Aga Khan University

Study ID Numbers ^ICMJE

297-Med/ERC-04

Study Sponsor ^ICMJE

Aga Khan University

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:	Shahab Abid, FCPS, FACG	The Aga Khan University
Study Director:	Wasim Jafri, FRCP, FACG	The Aga Khan University
Study Director:	Saeed S Hamid, FRCP, FACG	The Aga Khan University
Study Director:	Salih Mohammad, FCPS; MACG	The Aga Khan University

Information Provided By

Aga Khan University

Verification Date

September 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP