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

Sponsor:	Aga Khan University
Information provided by:	Aga Khan University
ClinicalTrials.gov Identifier:	NCT00534677

Purpose

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).

Condition	Intervention	Phase
Portal Hypertension Cirrhosis Hematemesis Melena	Drug: Terlipressin Drug: Octreotide	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	Efficacy And Safety Of Terlipressin Vs Octreotide As Adjuvant Therapy In Bleeding Esophageal Varices

Resource links provided by NLM:

Genetics Home Reference related topics: North American Indian childhood cirrhosis

MedlinePlus related topics: Cirrhosis Esophagus Disorders High Blood Pressure Varicose Veins

Drug Information available for: Terlipressin Octreotide acetate Octreotide

U.S. FDA Resources

Further study details as provided by Aga Khan University:

Primary Outcome Measures:

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

Enrollment:	320
Study Start Date:	May 2004
Study Completion Date:	July 2005

Arms	Assigned Interventions
Active Comparator: A	Drug: Terlipressin 2 mg stat & then 1 mg q6h iv and Placebo of Octreotide Other Name: Novapresin
Active Comparator: B	Drug: Octreotide Octreotide 50mcg/hr infusion & a placebo of Terlipressin Other Name: sandostatin

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00534677

Locations

Pakistan
The Aga Khan University Hospital
Karachi, Sindh, Pakistan, 74800

Sponsors and Collaborators

Aga Khan University

Investigators

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

More Information

No publications provided

Responsible Party:	Dr. Shahab Abid, The Aga Khan University
ClinicalTrials.gov Identifier:	NCT00534677 History of Changes
Other Study ID Numbers:	297-Med/ERC-04
Study First Received:	September 24, 2007
Last Updated:	December 4, 2007
Health Authority:	Pakistan: Research Ethics Committee

Keywords provided by Aga Khan University:

Variceal bleed
Cirrhosis
Vasoactive agents

Terlipressin
Octreotide
Safety & Efficacy

Additional relevant MeSH terms:

Esophageal and Gastric Varices
Hematemesis
Hypertension
Hypertension, Portal
Liver Cirrhosis
Fibrosis
Melena
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Liver Diseases
Gastrointestinal Hemorrhage
Hemorrhage
Pathologic Processes
Vomiting

Signs and Symptoms, Digestive
Signs and Symptoms
Vascular Diseases
Cardiovascular Diseases
Octreotide
Terlipressin
Lypressin
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Gastrointestinal Agents
Vasoconstrictor Agents
Cardiovascular Agents
Antihypertensive Agents

ClinicalTrials.gov processed this record on February 12, 2012