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

This study has been completed.
Information provided by:
Aga Khan University Identifier:
First received: September 24, 2007
Last updated: December 4, 2007
Last verified: September 2007
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
Drug: Terlipressin
Drug: Octreotide
Phase 4

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:

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.


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

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.
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Please refer to this study by its identifier: NCT00534677

The Aga Khan University Hospital
Karachi, Sindh, Pakistan, 74800
Sponsors and Collaborators
Aga Khan University
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

Responsible Party: Dr. Shahab Abid, The Aga Khan University 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
Vasoactive agents
Safety & Efficacy

Additional relevant MeSH terms:
Hypertension, Portal
Digestive System Diseases
Gastrointestinal Diseases
Gastrointestinal Hemorrhage
Liver Diseases
Pathologic Processes
Signs and Symptoms
Signs and Symptoms, Digestive
Antidiuretic Agents
Antihypertensive Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Gastrointestinal Agents
Natriuretic Agents
Physiological Effects of Drugs
Vasoconstrictor Agents processed this record on May 24, 2016